5 highlights at first Genomics and Precision Medicine Expo – Labiotech.eu

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Genomics and Precision Medicine Expo taking place on May 23 and 24 2023 at ExCeL London has announced its top 5 highlights for this years inaugural conference.

The event, which is being run in partnership with Genomics England, will explore the latest advancements and developments in genome sequencing and genomic testing, and the immediate and future potential for the development of precision medicine within the NHS and beyond.

Content throughout the two days will cover topics including discovery, research, development, and regulatory assessment, through to delivery, supply and patient referral.

Lucy Clarke, event manager of Genomics and Precision Medicine Expo, said: The event is a unique chance to discover critical updates, gain practical learnings that you can apply to your own work, and share insights with like-minded peers across patient care and science. With the UK being a key world leader in genomics testing and life sciences, there is a wealth of knowledge to be shared at the Genomics and Precision Medicine Expo.

The first day includes a session on precision cancer medicine: progress, limitations and opportunities. Precision medicine is the desire to tailor each persons treatment according to the underlying biology of their disease.

Also on the first day, a talk in the afternoon will examine implementing whole genome sequencing into routine clinical practice. All children in the U.K. with cancer are eligible for somatic and germline whole genome sequencing (WGS) via the NHS Genomic Medicine Service. Jack Bartram, a consultant pediatric hematologist at Great Ormond Street Hospital for Children (GOSH), will describe experiences of using WGS for hematological malignancies to obtain, analyze and clinically integrate results in a meaningful timeframe.

Another highlight is a panel discussion on navigating patient consent in cancer genomics. The use of genomic testing in routine care brings benefits for patient care and treatment, but it can also present new challenges for clinicians around consent. In this panel session involving representatives from Genomics England and The Royal Marsden NHS Foundation Trust, guests will explore different scenarios and approaches to consenting cancer patients for genomic testing.

On the second day, an afternoon presentation will look at the role of nurses in transforming genomic healthcare. The application of genomics in everyday practice is now a reality in cancer care and in rare diseases. Tootie Bueser, director for nursing & midwifery and chief nurse Southeast Genomic Medicine Service Alliance and North Thames Genomic Medicine Service Alliance will explore how nurses have an important role in transforming care through genomics and need access to education, training and other resources to maximize this opportunity.

The final highlight is a session on pharmacogenomics, hosted by Nisha Shaunak, associate chief pharmacist Cancer, TRU and Surgery Clinical Group, Guys & St Thomas NHS Foundation Trust.

Co-located with the Oncology Professional Care, Genomics and Precision Medicine Expo, the event is free to attend for registered healthcare professionals and individuals working in the field of genomics and precision medicine (excluding commercial companies) and is fully CPD accredited.

The co-located events feature 150+ sessions across seven focused theaters with product and service providers showcasing the latest innovations on the exhibition floor.

Genomics and Precision Medicine Expo intends to capture the interest of Public Health and ICS leaders, CCIOs within the NHS and private sector, clinicians working in acute and primary care who wish to develop their knowledge and understanding of the fast-moving developments in this sector, and clinical and biomedical scientists.Attendance is free for UK healthcare professionals and individuals working in the fields of genomics and precision medicine (in non-commercial roles). Register here: genomicsprecisionmedicine.co.uk

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5 highlights at first Genomics and Precision Medicine Expo - Labiotech.eu

Perceptions of Nigerian medical students regarding their … – BMC Medical Education

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A total of 300 medicine and surgery clinical students completed the survey (170 from the University of Lagos and 130 from Lagos State University) resulting in a 40% response rate (calculated as the number of completed questionnaires divided by the potential number of eligible participants based on the MDCN quota for both colleges). The sociodemographic characteristics of the respondents by knowledge, ability and summary scores are shown in Table1. Respondents were 19 to 39 years old with a median age of 23 (IQR: 2224) and slightly higher females (52.3%). At least a quarter of the respondents were from each level, with the majority from sixth (38.3%) and fifth years (36.3%). Most respondents (63.3%) indicated an interest in a career involving research.

Most respondents (92.0%, n=276) indicated they had heard of at least one of the precision medicine terminologies. The most commonly indicated terminology were Pharmacogenomics (71.0%, n=213) and Genomic Medicine (47.7%, n=143), while the least indicated terminologies were Genome-guided prescribing (19.7%, n=59) and Next Generation Sequencing (18.0%, n=54). Among those who had indicated awareness, the most commonly cited source of knowledge was Lectures (49.6%, n=137), Media (34.4%, n=95) and less commonly Healthcare providers (10.1%, n=28) and Peers (5.1%, n=14).

Knowledge scores of the respondents ranged from 4 to 20, with a median knowledge score of 12 (IQR: 814.5). Respondents were more comfortable about their knowledge of genetic variations predisposing to common diseases (43.3%, n=130) and pharmacogenomics (38.0%, n=114). They were least comfortable about their understanding of basic genomic testing concepts and terminology (29.7%, n=89) and next-generation sequencing (23.3%, n=70). The distribution of responses to knowledge questions is shown in Fig.1.

Distribution of knowledge and ability responses of participants

On univariate analyses, respondents medical school year was significantly associated with their knowledge score (F [2,297]=3.23, p=0.04). Compared to those in their 4th year, students in their 6th year had a 1.54-point lower mean knowledge score (95%CI: -2.83, -0.24; p=0.02) while those in 5th year had a 0.39-point lower mean knowledge score but this was not statistically significant (95%CI: -1.69, 0.92; p=0.56). Students who indicated an interest in a career involving research had a borderline significant 1.03-point higher mean knowledge score compared to those who did not (95%CI: -0.03, 2.08; p=0.06). Age, gender and ethnicity of participants did not show any significant associations with knowledge score of the participants.

After sequentially adjusting for age, gender, and interest in a research career, participants medical school year was significantly associated with knowledge score (F [2, 294]=4.78, p=0.009). Students in their 6th year had a statistically significant 2.16-point lower mean knowledge score than those in their 4th year (95%CI: -3.60, -0.72; p=0.003). After adjusting for age, gender, and interest in a career involving research, each unit increase in medical school year was associated with a statistically significant 1.10-point lower mean knowledge score (F [1,295]=8.97, ptrend = 0.003) [Table2].

The ability scores of the respondents ranged from 4 to 20, with a median score of 11 (IQR: 715). Respondents were more comfortable about their ability to recommend genetic testing options to patients (39.0%, n=117), to a lesser extent, understand genomic test results (30.3%, n=91 and were least comfortable in their ability to make treatment recommendations based on genomic test results (29.3%, n=88) and explain genomic test results to patients (29.3%, n=88). The distribution of responses to ability questions is shown in Fig.1.

On univariate analyses, respondents medical school year was significantly associated with ability scores (F [2,297]=6.26, p=0.002). Compared to students in their 4th year, students in their 5th year had a statistically significant 1.47-point lower mean ability score (95%CI: -2.84, -0.09; p=0. 04) while students in their 6th year had a statistically significant 2.44-point lower mean ability score (95%CI: -3.81, -1.08; p<0.001). In addition, each unit increase in knowledge score was significantly associated with a 0.77-point increase in mean ability score (95%CI: 0.69, 0.86; p<0.001). Age, gender, ethnicity of participants and interest in a career involving research did not show any significant associations.

After multivariate adjustments for age, gender, medical school year, interest in a career involving research and knowledge score, participants knowledge score (: 0.76 95%CI: 0.67, 0.84; p<0.001), and medical school year (F [2,293]=4.67, p=0.01) were independent predictors of ability score. Compared to students in their 4th year, students in their 5th year had a 1.24-point lower mean ability score (95%CI: -2.21, -0.27; p=0.01), and those in their 6th year had a 1.58-point lower mean ability score (95%CI: -2.66, -0.50; p=0.004). After adjusting for age, gender, interest in a career involving research and knowledge score, each unit increase in medical school year was associated with a significant 0.78-point lower mean ability score (F [1,294]=8.06, ptrend = 0.005) [Table3].

The attitude scores of participants ranged from 14 to 40, with a median score of 28 (IQR: 2433). The median score on the openness items was 15 (IQR: 1216). Respondents were more willing to use a patients genetic information to guide decisions in clinical practice (62.0%, n=186), use new types of therapies to help patients (60.0%, n=180), and use genome-guided tools developed by researchers (56.0%, n-168) but were less willing to use genome-guided prescribing in their career when senior physicians were not (41.0%, n=123). The median score on the divergence items was 15 (IQR: 1217). Respondents agreed that research-based genome-guided interventions were clinically useful (79.0%, n=237), were willing to prescribe different medications or doses of drugs (61.0%, n=183), to a lesser extent disagreed that clinicians know how to treat patients based on their genetic information better than researchers (52.0%, n=156), and to a much lesser extent disagreed that clinical experience is more important than using a patients genetic information to make decisions (36.3%, n=109). The distribution of responses to attitude questions is shown in Fig.2.

Distribution of participants responses to attitudes questions

Respondents responses to questions assessing their attitudes towards the adoption of genome-guided prescribing and precision medicine. Section A includes the distribution of responses to openness questions while section B includes the distribution of responses to divergence questions

On univariate analyses, each unit increase in knowledge score of the participants was significantly associated with a 0.14 decrease in mean attitude score (95%CI: -0.26, -0.02; p=0.03). Age, gender, ethnicity, medical school year and interest in a career involving research were not significantly associated with attitude scores. Although the association with knowledge score persisted after adjusting for age and gender, adjusting for medical school year and interest in a career involving research resulted in a trend towards a null association. After maximal adjustment for age, gender, knowledge score, and interest in a research career, students in their 6th year had a significant 1.65-point higher mean attitude score than those in their 4th year (95%CI: 0.75, 3.23; p=0.04). However, medical school year overall was not significantly associated with attitude scores (F [2,293]=2.50, p=0.08). Nevertheless, after maximal adjustment, each unit increase in medical school year was significantly associated with a 0.81-point increase in mean attitude scores (95%CI: 0.02, 1.60; ptrend = 0.04) [Table4]. Likelihood ratio chi-square tests did not reveal any evidence of statistical interaction between knowledge scores and medical school year (X2=2.66, p=0.26).

The distribution of ethical concerns expressed by respondents is shown in Fig.3. More than a quarter of the respondents were worried that genomic information obtained would be misused by government and corporate bodies (35.7%, n=107) and that their application would increase margins between the rich and the poor (34.0%, n=102). A similar proportion were worried that results from tests can affect employability if serious genetic defects are made known to their employers (33.0%, n=99) and that they will lead to insurance discrimination (30.0%, n=90). However, less than a quarter of the respondents felt that precision medicine approaches would lead to ethnic/racial discrimination (12.3%, n=37), and only 8.7% (n=26) of the respondents felt that precision medicine approaches would violate privacy and confidentiality.

Respondents perceptions of ethical concerns and education about Precision Medicine

Most respondents (65.0%, n=195) thought it was important to learn about precision medicine. Only 11.3% (n=34) of the respondents felt that their education had adequately prepared them to practice precision medicine. Only 10.7% (n=32) thought they knew who to ask about genomic testing. Finally, only 10.3% (n=31) of the respondents felt their professors had encouraged the use of precision medicine. The distribution of responses to education items is shown in Fig.3.

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Publication Bias Inflates Efficacy of Alprazolam XR: Study Reveals … – HealthDay

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WEDNESDAY, Nov. 22, 2023 (HealthDay News) -- Publication bias inflates the apparent efficacy of alprazolam extended-release, according to a study published online Oct. 19 in Psychological Medicine.

Rosa Y. Ahn-Horst, M.D., M.P.H., from Massachusetts General Hospital in Boston, and Erick H. Turner, M.D., from the Veterans Affairs Portland Health Care System in Oregon, examined publication bias with alprazolam by comparing its efficacy for panic disorder using trial results from the published literature and the U.S. Food and Drug Administration. Data were included from all phase 2/3 efficacy trials of alprazolam extended-release (Xanax XR) for the treatment of panic disorder.

The researchers identified five trials in the FDA review, one of which had positive results (20 percent). Of the four trials without positive results, two were published conveying a positive outcome and two were not published. Therefore, according to the three published trials, 100 percent were positive. Using FDA data, alprazolam's effect size was 0.33 versus 0.47 using published data, representing a 42 percent increase.

"Clinicians are well aware of these safety issues, but there's been essentially no questioning of their effectiveness," Turner said in a statement. "Our study throws some cold water on the efficacy of this drug. It shows it may be less effective than people have assumed."

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Publication Bias Inflates Efficacy of Alprazolam XR: Study Reveals ... - HealthDay

Pharmacogenomics – National Institute of General Medical …

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How is pharmacogenomics affecting medical treatment?

Currently, doctors prescribe drugs based mostly on factors such as a patients age, weight, sex, and liver and kidney function. For a few drugs, researchers have identified gene variants that affect how people respond. In these cases, doctors can select the best medication and dose for each patient.

Additionally, learning how patients respond to medications helps to discern the different forms of their diseases.

For many years, NIH-funded scientists, through the Pharmacogenomics Research Network (PGRN), have studied the effect of genes on medications relevant to a wide range of conditions, including asthma, depression, cancer, and heart disease. The research findings are collected in an online resource called PharmGKB. In addition, the Clinical Pharmacogenetics Implementation Consortium (CPIC) was started as a shared partnership between the PGRN and PharmGKB to help lower the barrier to clinical use of pharmacogenetic tests. CPIC creates, curates, and posts freely available, peer-reviewed, evidence-based, updatable, and detailed gene/drug clinical practice guidelines. Another NIH-funded project, the Clinical Genome Resource, aims to define the clinical relevance of genes and variants for use in precision medicine and research.

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Pharmacogenomics - National Institute of General Medical ...

The Future of Genomics in India – ETHealthWorld

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by Anand.K

The Human Genome Project is undoubtedly one of the most important and remarkable scientific feats in history and more recently, On March 31, 2022, the Telomere-to-Telomere (T2T) consortium announced that it had filled in the remaining gaps (roughly 8%) and produced the first truly complete human genome sequence. Highly accurate and long-read sequencing had finally removed technology limitations, enabling comprehensive studies of genomic variation across the entire human genome, which we expect to drive future discovery in human genomic health and disease.

continued below

Genomics applications in Rare Disorder Diagnosis Recently, a 19 month old child in the UK received lifesaving gene therapy for a rare disorder called metachromatic leukodystrophy. The ability to understand genomes quickly and inexpensively has led to advances in the diagnosis of rare disorders, thus helping families end their diagnostic odysseys. While rapid advances have been made in rare disorders, there are many disorders that may yet be discovered. Large scale research studies that are population specific would be required to understand the pattern of such diseases. This can provide significant relief to families with members suffering from such disorders, as well as help them understand the risk to future generations. 250+ such disorders have been identified. Through extensive genetic testing, it is possible to accelerate diagnosis and treatment options for patients living with rare diseases. Collaborations between public health organizations and private institutions, along with advocacy for mandatory new-born screening, can aid in reducing the inequalities that exist.

Prenatal testing to identify genetic disorders early in pregnancy Prenatal genetic tests required a pregnant woman to undergo invasive procedures to obtain a fetal DNA sample. Tests like amniocentesis and chorionic villus sampling comes with associated risks to pregnancy. With DNA sequencing, it is now possible to test the pregnant lady's blood for genomic variants in an unborn baby. NIPT (Non Invasive Prenatal Testing) or cell-free fetal DNA testing is now being extensively used to detect Down syndrome. With rapid advances in genomics, it is likely that we may be able to detect other genetic conditions very early.

In 2012, a new technique called CRISPR was invented that borrowed tools from bacteria to effectively edit any DNA in any organism. CRISPR is making it possible to edit genomes cheaper, faster, and more accurately than all previous methods. While CRISPR is now being used to study diseases, advances in this technology can also help in treating diseases. Research is being underway for Sickle Cell Disease and HIV. CRISPR has the potential to change gene therapy, and while it is still in its early stages, this could pave the way for new treatment options for a variety of life-threatening diseases.

The global genomics market size is projected to reach USD 94.65 billion by 2028, exhibiting a CAGR of 19.4% during the forecast period. While India is a land of 1.3 billion genomes and makes up 20% of the worlds population, the DNA sequences of our people only make up about 0.2% of global genetic databases. Therefore, we have a long way to go before we are able to reap the benefits of the genomics revolution at scale.

In the Union Budget 2022, Finance Minister Ms. Nirmala Sitharaman identified genomics as one of the sunrise opportunities and stated that the government will implement supportive policies to boost domestic capacities. Industry-academia collaborations, funding for research, and supportive regulatory and policy frameworks can truly transform how genomics can help healthcare delivery in India.

Anand.K, Chief Executive Officer, SRL Diagnostics

(DISCLAIMER: The views expressed are solely of the author and ETHealthworld does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person / organisation directly or indirectly.)

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Who are the leading innovators in microbiota restoration therapy for … – Pharmaceutical Technology

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The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalDatas report on Immuno-oncology in Pharmaceuticals: Microbiota restoration therapy.

According to GlobalDatas Technology Foresights, which uses over 756,000 patents to analyse innovation intensity for the pharmaceutical industry, there are 110 innovation areas that will shape the future of the industry.

Microbiota restoration therapy is a key innovation area in immuno-oncology

Microbiota restoration therapy can be composed of human faecal material containing viable gut flora from a patient or donor, and include a diluent and a cryoprotectant. The human faecal material is screened before using it in the restoration therapy for any pathogenic microorganisms.

GlobalDatas analysis also uncovers the companies at the forefront of each innovation area and assesses the potential reach and impact of their patenting activity across different applications and geographies. According to GlobalData, there are 240+ companies, spanning technology vendors, established pharmaceutical companies, and up-and-coming start-ups engaged in the development and application of microbiota restoration therapy.

Key players in microbiota restoration therapy a disruptive innovation in the pharmaceutical industry

Application diversity measures the number of different applications identified for each relevant patent and broadly splits companies into either niche or diversified innovators.

Geographic reach refers to the number of different countries each relevant patent is registered in and reflects the breadth of geographic application intended, ranging from global to local.

Source: GlobalData Patent Analytics

Probiotical is the leading patent filer for microbiota restoration therapy. Probiotical is a manufacturer of probiotics and synbiotics products. The companys activities consist of several stages of research and development, strain isolation, characterisation and production of probiotic strains for the prevention and treatment of various diseases, and design and implementation of specific probiotics and synbiotics finished products in many therapeutic areas, supported by clinical studies.

In terms of application diversity, Fate Therapeutics is the top company, followed by Imstem Biotechnology and the Spanish National Research Council. By means of geographic reach, the Spanish National Research Council holds the top position. While GI Innovation and Vitacare stand in second and third positions, respectively.

To further understand the key themes and technologies disrupting the pharmaceutical industry, access GlobalDatas latest thematic research report on Pharmaceutical.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalDatas Patent Analytics tracks patent filings and grants from official offices around the world. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies across the worlds largest industries.

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Who are the leading innovators in microbiota restoration therapy for ... - Pharmaceutical Technology

Effect of pharmacogenomics testing guiding on clinical outcomes in … – BMC Psychiatry

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Effect of pharmacogenomics testing guiding on clinical outcomes in ... - BMC Psychiatry

Pharmacogenomics – Genome.gov

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Understanding pharmacogenomics would not be possible without sequencing the genomes of many people and comparing them, and then comparing their response to medicines. But we have also learned that a person's genome sequence is not everything when it comes to medication responses. The human body is a very complicated machine, and the instructions written in our DNA are just part of the process.

There are some cases, as with the breast cancer treatment tamoxifen, where a small study showed that there might be a relationship between someone's response to the medicine and a variant in theCYP2D6gene. However, this finding did not appear to be true in a larger study that involved many more people. That's why at this time, the U.S. Food and Drug Administration (FDA) labeling for tamoxifen does not recommendCYP2D6pharmacogenomic testing, butthe issue is still being reviewedas more research is conducted.

Another gene in the sameCYPfamily, calledCYP2C19, has variations which affect how your body can useclopidogrel(more commonly known as Plavix). This medication is a "blood thinner" which helps prevent blood clots, and thus reduces your risk of strokes or some heart attacks. If yourCYP2C19protein is not working properly due to a mutation in the gene, then you will not be able toprocess clopidogrel, and you need either a different dose or a different medication. As it turns out, these variants inCYP2C19are also more common in those with Asian ancestry. Although testing for variants in this gene is also not routinely recommended, you may wish to speak with your healthcare provider about the test if you are given a prescription for clopidogrel, particularly if you have East Asian family members.

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Pharmacogenomics - Genome.gov

Pharmacogenomics | National Institutes of Health (NIH)

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In the 1970s, NIH research gave us genetic engineering and launched what is today the $100 billion biotechnology industry, a major source of high-paying U.S. jobs. Virtually every biomedical research lab and pharmaceutical company uses the power of the genomic revolution every day to demystify diseases and search for new cures. Companies today can read the entire DNA sequence of an individual for less than $1,000, and the cost is dropping quickly. This ability to study massive amounts of DNA has helped the field of pharmacogenomics mature rapidly. In this area of science, researchers match DNA patterns in individuals with how they respond to medications. The goal is to move away from one-size-fits-all dosing because we now know that many factors aside from sex, age, and body size influence how our bodies react, ordont, to many drugs. Research results in this important area of biomedicine have prompted FDA to include pharmacogenomic information in drug labeling, toward more precise and safer drug responses for patients. A significant goal of precision medicine is to implement this strategy broadly in medical care focusing on the right drug at the right dose at the right time for the right patient.

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Pharmacogenomics | National Institutes of Health (NIH)

Genetics vs. Genomics Fact Sheet – National Human Genome Research Institute

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Proteomics

The suffix "-ome" comes from the Greek for all, every, or complete. It was originally used in "genome," which refers to all the genes in a person or other organism. Due to the success of large-scale biology projects such as the sequencing of the human genome, the suffix "-ome" is now being used in other research contexts. Proteomics is an example. The DNA sequence of genes carries the instructions, or code, for building proteins. This DNA is transcribed into a related molecule, RNA, which is then translated into proteins. Proteomics, therefore, is a similar large-scale analysis of all the proteins in an organism, tissue type, or cell (called the proteome). Proteomics can be used to reveal specific, abnormal proteins that lead to diseases, such as certain forms of cancer.

Pharmacogenetics and Pharmacogenomics

The terms "pharmacogenetics" and "pharmacogenomics" are often used interchangeably in describing the intersection of pharmacology (the study of drugs, or pharmaceuticals) and genetic variability in determining an individual's response to particular drugs. The terms may be distinguished in the following way.

Pharmacogenetics is the field of study dealing with the variability of responses to medications due to variation in single genes. Pharmacogenetics takes into account a person's genetic information regarding specific drug receptors and how drugs are transported and metabolized by the body. The goal of pharmacogenetics is to create an individualized drug therapy that allows for the best choice and dose of drugs. One example is the breast cancer drug trastuzumab (Herceptin). This therapy works only for women whose tumors have a particular genetic profile that leads to overproduction of a protein called HER2. (See: Genetics, Disease Prevention and Treatment)

Pharmacogenomics is similar to pharmacogenetics, except that it typically involves the search for variations in multiple genes that are associated with variability in drug response. Since pharmacogenomics is one of the large-scale "omic" technologies, it can examine the entirety of the genome, rather than just single genes. Pharmacogenomic studies may also examine genetic variation among large groups of people (populations), for example, in order to see how different drugs might affect different racial or ethnic groups.

Pharmacogenetic and pharmacogenomic studies are leading to drugs that can be tailor-made for individuals, and adapted to each person's particular genetic makeup. Although a person's environment, diet, age, lifestyle, and state of health can also influence that person's response to medicines, understanding an individual's genetic makeup is key to creating personalized drugs that work better and have fewer side effects than the one-size-fits-all drugs that are common today. (See: Genetics, Disease Prevention and Treatment). For example, the U.S. Food and Drug Administration (FDA) recommends genetic testing before giving the chemotherapy drug mercaptopurine (Purinethol) to patients with acute lymphoblastic leukemia. Some people have a genetic variant that interferes with their ability to process this drug. This processing problem can cause severe side effects, unless the standard dose is adjusted according to the patient's genetic makeup. (See: Frequently Asked Questions about Pharmacogenomics).

Stem Cell Therapy

Stem cells have two important characteristics. First, stem cells are unspecialized cells that can develop into various specialized body cells. Second, stem cells are able to stay in their unspecialized state and make copies of themselves. Embryonic stem cells come from the embryo at a very early stage in development (the blastocyst staqe). The stem cells in the blastocyst go on to develop all of the cells in the complete organism. Adult stem cells come from more fully developed tissues, like umbilical cord blood in newborns, circulating blood, bone marrow or skin.

Medical researchers are investigating the use of stem cells to repair or replace damaged body tissues, similar to whole organ transplants. Embryonic stem cells from the blastocyst have the ability to develop into every type of tissue (skin, liver, kidney, blood, etc.) found in an adult human. Adult stem cells are more limited in their potential (for example, stem cells from liver may only develop into more liver cells). In organ transplants, when tissues from a donor are placed into the body of a patient, there is the possibility that the patient's immune system may react and reject the donated tissue as "foreign." However, by using stem cells, there may be less risk of this immune rejection, and the therapy may be more successful.

Stem cells have been used in experiments to form cells of the bone marrow, heart, blood vessels, and muscle. Since the 1990's, umbilical cord blood stem cells have been used to treat heart and other physical problems in children who have rare metabolic conditions, or to treat children with certain anemias and leukemias. For example, one of the treatment options for childhood acute lymphoblastic leukemia [cancer.gov] is stem cell transplantation therapy.

There has been much debate nationally about the use of embryonic stem cells, especially about the creation of human embryos for use in experiments. In 1995, Congress enacted a ban on federal financing for research using human embryos. However, these restrictions have not stopped researchers in the United States and elsewhere from using private funding to create new embryonic cell lines and undertaking research with them. The embryos for such research are typically obtained from embryos that develop from eggs that have been fertilized in vitro - as in an in vitro fertilization clinic - and then donated for research purposes with informed consent of the donors. In 2009, some of the barriers to federal financing of responsible and scientifically worthy human stem cell research were lifted.

Cloning

Cloning can refer to genes, cells, or whole organisms. In the case of a cell, a clone refers to any genetically identical cell in a population that comes from a single, common ancestor. For example, when a single bacterial cell copies its DNA and divides thousands of times, all of the cells that are formed will contain the same DNA and will be clones of the common ancestor bacterial cell. Gene cloning involves manipulations to make multiple identical copies of a single gene from the same ancestor gene. Cloning an organism means making a genetically identical copy of all of the cells, tissues, and organs that make up the organism. There are two major types of cloning that may relate to humans or other animals: therapeutic cloning and reproductive cloning.

Therapeutic cloning involves growing cloned cells or tissues from an individual, such as new liver tissue for a patient with a liver disease. Such cloning attempts typically involve the use of stem cells. The nucleus will be taken from a patient's body cell, such as a liver cell, and inserted into an egg that has had its nucleus removed. This will ultimately produce a blastocyst whose stem cells could then be used to create new tissue that is genetically identical to that of the patient.

Reproductive cloning is a related process used to generate an entire animal that has the same nuclear DNA as another currently or previously existing animal. The first cloned animals were frogs. Dolly, the famous sheep, is another example of cloning. The success rates of reproductive animal cloning, however, have been very low. In 2005, South Korean researchers claimed to have produced human embryonic stem cell lines by cloning genetic material from patients. However, this data was later reported to have been falsified.

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Genetics vs. Genomics Fact Sheet - National Human Genome Research Institute

PHARMACOGENOMICS: Driving Personalized Medicine

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Personalized medicine tailors therapies, disease prevention, and health maintenance to the individual, with pharmacogenomics serving as a key tool to improve outcomes and prevent adverse effects. Advances in genomics have transformed pharmacogenetics, traditionally focused on single gene-drug pairs, into pharmacogenomics, encompassing all 'omics' fields, e.g., proteomics, transcriptomics, metabolomics, and metagenomics. This review summarizes basic genomics principles relevant to translation into therapies, assessing pharmacogenomics' central role in converging diverse elements of personalized medicine. We discuss genetic variations in pharmacogenes (drug-metabolizing enzymes, drug transporters, and receptors), their clinical relevance as biomarkers, and the legacy of decades of research in pharmacogenetics. All types of therapies, including proteins, nucleic acids, viruses, cells, genes, and irradiation, can benefit from genomics, expanding the role of pharmacogenomics across medicine. FDA approvals of personalized therapeutics involving biomarkers increase rapidly, demonstrating the growing impact of pharmacogenomics. A beacon for all therapeutic approaches, molecularly targeted cancer therapies highlight trends in drug discovery and clinical applications. To account for human complexity, multi-component biomarker panels encompassing genetic, personal, and environmental factors can guide diagnosis and therapies, increasingly involving artificial intelligence to cope with extreme data complexities. However, clinical application encounters substantial hurdles, such as unknown validity across ethnic groups, underlying bias in health care, and real-world validation. This review will address the underlying science and technologies germane to pharmacogenomics and personalized medicine, integrated with economic, ethical, and regulatory issues - providing insights into the current status and future direction of health care. Significance Statement Personalized medicine aims to optimize health care for the individual patients with use of predictive biomarkers to improve outcomes and prevent adverse effects. Pharmacogenomics drives biomarker discovery and guides the development of targeted therapeutics. This review addresses basic principles and current trends in pharmacogenomics, with large-scale data repositories accelerating medical advances. The impact of pharmacogenomics is discussed, along with hurdles impeding broad clinical implementation, in the context of clinical care, ethics, economics, and regulatory affairs.

Keywords: Genetic polymorphisms; cancer; developmental pharmacology; drug metabolism; drug-drug interactions; gene regulation/transcription; pharmacogenetics/pharmacogenomics; systems pharmacology.

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PHARMACOGENOMICS: Driving Personalized Medicine

PhD Degree Program in Pharmaceutical Sciences and Pharmacogenomics …

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About the program

The Pharmaceutical Sciences and Pharmacogenomics (PSPG) Graduate Program at the University of California, San Francisco (UCSF) focuses on how to develop effective drug therapies for patients that have a minimum of adverse effects. To do this we give our graduate students solid training in the pharmaceutical-related basic sciences and create an environment in which students can develop into independent and creative scientific problem-solvers. This multidisciplinary graduate program has a dual focus: pharmaceutical sciences and drug development, and pharmacogenomics, which is the application of genetics and genomics to drug action and disposition. The result of this dual focus is that it trains the next generation of scientists to explore new drugs in novel ways.

PSPG welcomes scientists of any race, religion, national origin, gender identity, caregiver and family commitments, political affiliation, sexual orientation, and eligible age or ability. We believe Black Lives Matter and are committed to sustained action to reduce racism and inequity in science. More details:Diversity, Equity, and Inclusion.

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PhD Degree Program in Pharmaceutical Sciences and Pharmacogenomics ...

Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA

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AbacavirInfectious DiseasesHLA-BBoxed Warning, Dosage and Administration, Contraindications, Warnings and PrecautionsAbemaciclib (1)OncologyESR(Hormone Receptor)Indications and Usage, Adverse Reactions, Clinical StudiesAbemaciclib (2)OncologyERBB2(HER2)Indications and Usage, Adverse Reactions, Clinical StudiesAbemaciclib (3)OncologyMKI67Indications and Usage, Dosage and Administration, Clinical StudiesAbrocitinibDermatologyCYP2C19Dosage and Administration, Use in Specific Populations, Clinical PharmacologyAdo-Trastuzumab EmtansineOncologyERBB2(HER2)Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAducanumab-avwaNeurologyAPOEWarnings and Precautions, Clinical StudiesAfatinibOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAlectinibOncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAlglucosidase AlfaInborn Errors of MetabolismGAAWarnings and PrecautionsAllopurinolOncologyHLA-BWarningsAlpelisib (1)OncologyERBB2(HER2)Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAlpelisib (2)OncologyESR(Hormone Receptor)Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAlpelisib (3)OncologyPIK3CAIndication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAmifampridineNeurologyNAT2Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical PharmacologyAmifampridine PhosphateNeurologyNAT2Dosage and Administration, Use in Specific Populations, Clinical PharmacologyAmitriptylinePsychiatryCYP2D6PrecautionsAmivantamab-vmjwOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAmoxapinePsychiatryCYP2D6PrecautionsAmphetaminePsychiatryCYP2D6Clinical PharmacologyAnakinraRheumatologyNLRP3Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesAnastrozoleOncologyESR, PGR(Hormone Receptor)Indications and Usage, Adverse Reactions, Drug Interactions, Clinical StudiesAnifrolumab-fniaRheumatologyGene Signature(IFN)Clinical Pharmacology, Clinical StudiesArformoterol (1)PulmonaryUGT1A1Clinical PharmacologyArformoterol (2)PulmonaryCYP2D6Clinical PharmacologyAripiprazolePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyAripiprazole LauroxilPsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyArsenic TrioxideOncologyPML-RARAIndications and Usage, Clinical StudiesArticaine and Epinephrine (1)AnesthesiologyG6PDWarnings and PrecautionsArticaine and Epinephrine (2)AnesthesiologyNonspecific(Congenital Methemoglobinemia)Warnings and PrecautionsAsciminibOncologyBCR-ABL1(Philadelphia chromosome)Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesAtezolizumab (1)OncologyCD274(PD-L1)Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical StudiesAtezolizumab (2) OncologyGene Signature(T-effector)Clinical StudiesAtezolizumab (3)OncologyEGFRIndications and Usage, Adverse Reactions, Clinical StudiesAtezolizumab (4)OncologyALKIndications and Usage, Adverse Reactions, Clinical StudiesAtezolizumab (5)OncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesAtomoxetinePsychiatryCYP2D6Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical PharmacologyAscorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium SulfateGastroenterologyG6PDWarnings and Precautions, Adverse ReactionsAvapritinib (1)OncologyPDGFRAIndications and Usage, Dosage and Administration, Clinical StudiesAvapritinib (2)OncologyKITClinical StudiesAvatrombopag (1)HematologyF2(Prothrombin)Warnings and PrecautionsAvatrombopag (2)HematologyF5(Factor V Leiden)Warnings and PrecautionsAvatrombopag (3)HematologyPROCWarnings and PrecautionsAvatrombopag (4)HematologyPROS1Warnings and PrecautionsAvatrombopag (5)HematologySERPINC1(Antithrombin III)Warnings and PrecautionsAvatrombopag (6)HematologyCYP2C9Clinical PharmacologyAvelumabOncologyCD274(PD-L1)Clinical StudiesAzacitidine (1)OncologyCBLClinical StudiesAzacitidine (2)OncologyPTPN11Clinical StudiesAzacitidine (3)OncologyRASClinical StudiesAzathioprine (1)RheumatologyTPMTDosage and Administration, Warnings, Precautions, Drug Interactions, Adverse Reactions, Clinical PharmacologyAzathioprine (2)RheumatologyNUDT15Dosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical PharmacologyBelinostatOncologyUGT1A1Dosage and Administration, Clinical PharmacologyBelzutifan (1)OncologyCYP2C19Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical PharmacologyBelzutifan (2)OncologyUGT2B17Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical PharmacologyBelzutifan (3)OncologyVHLClinical StudiesBinimetinib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesBinimetinib (2)OncologyUGT1A1Clinical PharmacologyBlinatumomab (1)OncologyBCR-ABL1(Philadelphia chromosome)Adverse Reactions, Clinical StudiesBlinatumomab (2)OncologyCD19Indications and UsageBoceprevirInfectious DiseasesIFNL3(IL28B)Clinical PharmacologyBosutinibOncologyBCR-ABL1(Philadelphia chromosome)Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesBrentuximab Vedotin (1)OncologyALKClinical StudiesBrentuximab Vedotin (2)OncologyTNFRSF8(CD30)Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesBrexpiprazolePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyBrigatinibOncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesBrivaracetamNeurologyCYP2C19Clinical PharmacologyBupivacaine (1) AnesthesiologyG6PDWarningsBupivacaine (2)AnesthesiologyNonspecific(Congenital Methemoglobinemia)WarningsBupropionPsychiatryCYP2D6Clinical PharmacologyBusulfanOncologyBCR-ABL1(Philadelphia chromosome)Clinical StudiesCabotegravir and Rilpivirine (1)Infectious DiseasesHLA-BClinical StudiesCabotegravir and Rilpivirine (2)Infectious DiseasesUGT1A1Clinical PharmacologyCabozantinibOncologyRETClinical StudiesCapmatinibOncologyMETIndications and Usage, Dosage and Administration, Clinical StudiesCapecitabineOncologyDPYDWarnings and Precautions, Patient Counseling InformationCarbamazepine (1)NeurologyHLA-BBoxed Warning, Warnings, PrecautionsCarbamazepine (2)NeurologyHLA-AWarningsCarglumic AcidInborn Errors of MetabolismNAGSIndications and Usage, Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCariprazinePsychiatryCYP2D6Clinical PharmacologyCarisoprodolRheumatologyCYP2C19Use in Specific Populations, Clinical PharmacologyCarvedilolCardiologyCYP2D6Drug Interactions, Clinical PharmacologyCasimersenNeurologyDMDIndications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCeftriaxone (1)Infectious DiseasesG6PDWarningsCeftriaxone (2)Infectious DiseasesNonspecific(Congenital Methemoglobinemia)WarningsCelecoxibRheumatologyCYP2C9Dosage and Administration, Use in Specific Populations, Clinical PharmacologyCemiplimab-rwlc (1)OncologyALKIndications and Usage, Clinical StudiesCemiplimab-rwlc (2)OncologyCD274(PD-L1)Indications and Usage, Dosage and Administration, Clinical StudiesCemiplimab-rwlc (3)OncologyEGFRIndications and Usage, Clinical StudiesCemiplimab-rwlc (4)OncologyROS1Indications and Usage, Clinical StudiesCeritinibOncologyALKIndications and Usage, Dosage and Administration, Warning and Precautions, Adverse Reactions, Clinical StudiesCerliponase AlfaInborn Errors of MetabolismTPP1Indications and Usage, Use in Specific Populations, Clinical StudiesCetuximab (1)OncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesCetuximab (2)OncologyRASIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical StudiesCetuximab (3)OncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesCevimelineDentalCYP2D6PrecautionsChloroprocaine (1)AnesthesiologyG6PDWarningsChloroprocaine (2)AnesthesiologyNonspecific(Congenital Methemoglobinemia)WarningsChloroquineInfectious DiseasesG6PDPrecautions, Adverse ReactionsChlorpropamideEndocrinologyG6PDPrecautionsCholic AcidInborn Errors of MetabolismAMACR, AKR1D1, CYP7A1, CYP27A1, DHCR7, HSD3B2(Bile Acid Synthesis Disorders)Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesCisplatinOncologyTPMTAdverse ReactionsCitalopram (1)PsychiatryCYP2C19Dosage and Administration, Warnings,Clinical PharmacologyCitalopram (2)PsychiatryCYP2D6Clinical PharmacologyClobazamNeurologyCYP2C19Dosage and Administration, Use in Specific Populations, Clinical PharmacologyClomipraminePsychiatryCYP2D6PrecautionsClopidogrelCardiologyCYP2C19Boxed Warning, Warnings and Precautions, Clinical PharmacologyClozapinePsychiatryCYP2D6Dosage and Administration, Use in Specific Populations, Clinical PharmacologyCobimetinibOncologyBRAFIndications and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesCodeineAnesthesiologyCYP2D6Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling InformationCrizanlizumab-tmcaHematologyHBBAdverse Reactions, Clinical StudiesCrizotinib (1)OncologyALKIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesCrizotinib (2)OncologyROS1Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesDabrafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesDabrafenib (2)OncologyG6PDWarnings and Precautions, Adverse Reactions, Patient Counseling InformationDabrafenib (3)OncologyRASDosage and Administration, Warnings and PrecautionsDaclatasvirInfectious DiseasesIFNL3(IL28B)Clinical StudiesDacomitinibOncologyEGFRIndications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical StudiesDapsone (1)DermatologyG6PDWarnings and Precautions, Use in Specific Populations, Patient Counseling InformationDapsone (2)DermatologyNonspecific(Congenital Methemoglobinemia)Warnings and Precautions, Adverse Reactions, Patient Counseling InformationDapsone (3)Infectious DiseasesG6PDPrecautions, Adverse Reactions, OverdosageDarifenacinUrologyCYP2D6Clinical PharmacologyDasabuvir, Ombitasvir, Paritaprevir, andRitonavirInfectious DiseasesIFNL3(IL28B)Clinical StudiesDasatinibOncologyBCR-ABL1(Philadelphia chromosome)Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical StudiesDenileukin DiftitoxOncologyIL2RA(CD25 antigen)Indications and Usage, Clinical StudiesDesipraminePsychiatryCYP2D6PrecautionsDesfluraneAnesthesiologyNonspecific(Genetic Susceptibility to Malignant Hyperthermia)ContraindicationsDesvenlafaxinePsychiatryCYP2D6Clinical PharmacologyDeutetrabenazineNeurologyCYP2D6Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical PharmacologyDexlansoprazoleGastroenterologyCYP2C19Drug Interactions, Clinical PharmacologyDextromethorphan and QuinidineNeurologyCYP2D6Warnings and Precautions, Clinical PharmacologyDiazepamNeurologyCYP2C19Clinical PharmacologyDinutuximabOncologyMYCNClinical StudiesDocetaxelOncologyESR, PGR(Hormone Receptor)Clinical StudiesDolutegravirInfectious DiseasesUGT1A1Clinical PharmacologyDonepezilNeurologyCYP2D6Clinical PharmacologyDostarlimab-gxlyOncologyMismatch RepairIndication and Usage, Dosage and Administration, Adverse Reactions, Clinical StudiesDoxepin (1)PsychiatryCYP2D6Clinical PharmacologyDoxepin (2)PsychiatryCYP2C19Clinical PharmacologyDronabinolGastroenterologyCYP2C9Use in Specific Populations, Clinical PharmacologyDrospirenone and Ethinyl EstradiolGynecologyCYP2C19Clinical PharmacologyDuloxetinePsychiatryCYP2D6Drug InteractionsDurvalumabOncologyCD274(PD-L1)Clinical Pharmacology, Clinical StudiesDuvelisibOncologyChromosome 17pClinical StudiesEculizumab (1)NeurologyACHRIndications and Usage, Clinical StudiesEculizumab (2)NeurologyAQP4Indications and Usage, Clinical StudiesEfavirenzInfectious DiseasesCYP2B6Clinical PharmacologyEfgartigimod Alfa-fcabNeurologyACHRIndications and Usage, Clinical Pharmacology, Clinical StudiesElagolixGynecologySLCO1B1Clinical PharmacologyElbasvir and GrazoprevirInfectious DiseasesIFNL3(IL28B)Clinical StudiesElexacaftor, Ivacaftor, and TezacaftorPulmonaryCFTRIndications and Usage, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEliglustatInborn Errors of MetabolismCYP2D6Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesElosulfaseInborn Errors of MetabolismGALNSIndications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEltrombopag (1)HematologyF5(Factor V Leiden)Warnings and PrecautionsEltrombopag (2)HematologySERPINC1(Antithrombin III)Warnings and PrecautionsEltrombopag (3)HematologyChromosome 7Adverse ReactionsEltrombopag (4)HematologyChromosome 13Adverse ReactionsEmapalumab-lzsgHematologyPRF1, RAB27A, SH2D1A, STXBP2, STX11, UNC13D, XIAP (Hemophagocytic Lymphohistiocytosis)Clinical StudiesEnasidenibOncologyIDH2Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical StudiesEncorafenib (1)OncologyBRAFIndications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical StudiesEncorafenib (2)OncologyRASDosage and Administration, Warnings and Precautions, Clinical StudiesEnfortumab Vedotin-ejfvOncology

NECTIN4

SERPINC1(Antithrombin III)

ERBB2(HER2)

Indications and Usage, Adverse Reactions, Clinical Studies

Clinical Studies

Indications and Usage, Clinical Studies

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Table of Pharmacogenomic Biomarkers in Drug Labeling | FDA

DATAR CANCER GENETICS ANNOUNCES FORAY INTO THE UNITED STATES WITH A $250M CONTRACT TO OFFER PIONEERING CANCER DETECTION LIQUID BIOPSIES – Yahoo…

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LONDON, May 9, 2022 /PRNewswire/ -- Datar Cancer Genetics ("Datar"), a world-leading cancer research corporation today announced a $250 million contract with Artemis DNA, a leading USA-based diagnostic laboratory company that provides proprietary Next Generation Sequencing (NGS) genetic testing and diagnostic laboratory services for a wide variety of medical specialties, including cardiology, oncology, immunology, neurology, reproductive health and pharmacogenomics. Under the 5 years exclusive agreement, Artemis DNA will provide Datar's pioneering cancer detection Liquid Biopsies in the USA and Vietnam markets.

Trucheck_Pragma_CancerTrack

The deal covers two solutions from Datar's cancer screening and diagnostic portfolio - Trucheck Pragma and Cancertrack. Trucheck Pragma is a non-invasive, blood-based screening test for Lung, Stomach, Colon, Pancreas, Prostate, Breast, and Ovarian cancers. Cancertrack is for the evaluation of response/resistance/recurrence during the management of cancer. The solutions will be presently offered as Laboratory Developed Tests (LDTs) in the USA.

In addition, Artemis DNA will provide Datar with high-complexity CLIA certified, CAP-accredited testing facilities in Texas and California to enable the commercial launch of various cancer screening and diagnostic tests developed by Datar.

"We are extremely delighted to offer our highly accurate cancer detection technology for the benefit of patients in the USA and Vietnam in partnership with Artemis DNA. Their marketing strength and experience will enable a seamless roll-out of our innovative, game-changing, life-saving Liquid Biopsies," commented Mr. Rajan Datar, Chairman of Datar Cancer Genetics. "We will continue to expand our offerings in the USA and European markets with high standards of accuracy and quality of service," he added.

"We are so excited to be able to offer the ground-breaking technologies to patients in the USA and Vietnam," commented Ms. Emylee Thai, Founder and CEO of Artemis DNA. "Datar Cancer Genetics continues to innovate and push the boundaries on what people thought was impossible when it comes to cancer screening, diagnosis and management. Artemis DNA is proud to be part of the pioneers to help change the landscape of early screening and diagnosis, as well as management of cancer, which will improve and save lives."

Story continues

Datar Cancer Genetics is a global oncology research and applications company specializing in non-invasive technologies for improved detection, treatment, and management of cancer. Datar's state-of-the-art facility is ISO, CAP-accredited and CLIA certified. Datar's tests for early detection of Breast and Prostate cancer have been granted 'Breakthrough Designation' by the US FDA. The Company serves cancer patients and suspected cases in the UK, European Union, United States, GCC, and India. The Company has already established an advanced research and testing facility at Guildford, UK, and is pursuing large clinical studies across various geographies to cover multiple cancers where there is a potential for cure with early detection. The Company also proposes to roll out multiple test centers globally.

CONTACT: Dr. Vineet Dattadrvineetdatta@datarpgx.com

Website: trucheck360.com

Image: https://mma.prnewswire.com/media/1813311/Trucheck_Pragma_CancerTrack.jpgLogo: https://mma.prnewswire.com/media/1572835/Datar_Cancer_Genetics_Logo.jpg

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SOURCE Datar Cancer Genetics

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DATAR CANCER GENETICS ANNOUNCES FORAY INTO THE UNITED STATES WITH A $250M CONTRACT TO OFFER PIONEERING CANCER DETECTION LIQUID BIOPSIES - Yahoo...

Top experts to attend Precision Medicine and Functional Genomics conference – Gulf Times

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The Precision Medicine and Functional Genomics (PMFG) 2022 conference is all set to take place from September 23 to 26 at St Regis Doha, bringing together researchers, healthcare professionals, policymakers, and community members from different countries.Precision Medicine takes individual variations in genetics, pharmacogenomics, proteomics, microbiome, environmental, lifestyle factors, and others into account, allowing healthcare providers to improve the efficiency and effectiveness of disease prevention, diagnosis, and treatment, Sidra Medicines chief research officer Dr Khalid Fakhro said in a statement.The sixth edition of the annual event, which will be preceded by a pre-symposium Biotech Forum tomorrow (September 22) at Sidra Medicines hospital auditorium, aims to explore the latest developments and innovations in biomedical research and how they translate into precision medicine solutions.According to the organisers, the four-day in-person symposium has pre-and post-conference workshops, as well as a satellite half-day meeting focusing on two major themes: How cellular, organoid, and animal models are being used to facilitate the discovery of basic disease mechanisms and potential cures; and The development of advanced therapies to treat diseases.Over the years, the PMFG series has grown significantly in topics and diversity with a wide range of speakers and a growing audience worldwide. As part of its National Vision 2030, Qatar is committed to building a knowledge-based economy in the biomedical and health sciences. Sidra Medicine supports this goal by actively engaging clinical and scientific expertise to establish a leading model for Precision Medicine in the region, Dr Fakhro said. He noted that the conference also aims to discover how personalised medicine can move from vision to practice and to draft with us the roadmap for a personalised health data ecosystem.Organisers noted that the conference provides an opportunity for participants to: Learn about co-ordinated efforts to develop precision medicine around the world and specifically in the Middle Eastern region, best practices for conducting successful precision medicine clinical trials, learn how advanced diagnostics and personalised treatments improve the quality of care for children with rare and chronic diseases (i.e. immune deficiency, hemoglobinopathy, cancer, etc), understand the value of using cell, organoid, and animals as disease models in biomedical research and learn about modelling of human tissues and diseases and how large-scale data resources, genome sequencing and novel technologies are driving precision medicine.

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Supporting and enhancing the evolving role of MSLs PharmaLive – PharmaLive

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Supporting and enhancing the evolving role of MSLs

By Jill Padgett, EdD

Medical science liaisons (MSLs) play an essential and prominent role in the pharmaceutical industry. They form a link between pharmaceutical companies and the medical community, working to ensure that information about new drugs and treatments is disseminated accurately and effectively.

The pace of medical research that were experiencing currently will lead to increased frequency of product launches, more multi-indication brands, and a strong focus on rare disease and specialty care. As a result, the market landscape and corresponding needs of HCPs are becoming increasingly complex. Indeed, in cases such as those involving rare diseases where there may be only a small number of specialists HCPs will place greater reliance on MSLs as a primary resource with respect to innovative therapies.

The landscape is changing in other ways, too. The pandemic has only accelerated the already sizable shift to digital communications. And with the increasingly fast-paced nature of society in general, time-crunched HCPs can be more difficult to engage.

To support the various market changes, the scope of the average MSL function will expand. This article explores the evolving role of MSLs and their value for biopharmaceutical companies, and examines how best to utilize their expertise.

The impact of rare disease on MSLs

A key driver of change is the escalation of therapies in the field of rare diseases. This is accompanied by accelerated timelines as companies rush to get products to market. The increased complexity and urgency can lead to knowledge and communication gaps that MSLs are uniquely poised to bridge. They act as trusted sources for KOLs and HCPs who are facing a range of challenges, including inconsistencies in, and approaches to, care.

Additionally, when it comes to rare disease, there is often minimal data available and few KOLs to consult. This is an area where the MSL role has expanded. They now play a key part in helping to cultivate KOL influencers. There are also other players that MSLs will need to identify because oftentimes, different stakeholders or experts are involved in a patients treatment. The MSLs role now involves understanding what each of those different stakeholders provides in the patient journey, what they need based on their own knowledge of the disease, and their insights and perspectives on the patients care.

MSLs must be able to identify major influencers and handle diverse conversations with each stakeholder. They need to simultaneously take on a holistic and micro view of issues, and be able to draw key insights that are most important for the pharmaceutical company.

Another trend driven by the prevalence of rare disease treatments is the need for MSLs to be well-versed in pharmacogenomics, which studies the impact of genetics on patients response to medications. This can affect small populations, and knowledge of pharmacogenomics can help MSLs personalize conversations with HCPs and increase confidence in a particular therapy based on how patients are expected to respond.

Typically, pharmacogenomics is not a part of an MSL training curriculum, depending on what therapeutic areas theyre working in. However, in rare diseases, it is a critical component of MSL development. In addition to learning about pharmacogenomics, MSLs must also become knowledgeable in personalized medicine, pharmacoeconomics, and evidence-based medicine. With fewer KOLs, they play an important role in educating HCPs and providing in-depth knowledge on these topics.

Building connections that make better health happen

The MSL role is changing from a practical standpoint, too. HCPs, KOLs, and other stakeholders in the field are rapidly shifting toward digital communications. MSLs need to adapt their approach to avoid missing out on timely and effective collaboration opportunities. This might involve an expanded suite of digital tools, increased personalization, or testing various hybrid communication methods.

Post-pandemic, many KOLs have grown accustomed to the virtual environment, some still prefer in-person meetings, while others favor a mixture. To communicate effectively, MSLs must be more versatile, technically savvy, and armed with the necessary digital assets. One way to help MSLs navigate new communication methods is for pharmaceutical companies to ensure they have all the digital tools (e.g., slide decks and digital brochures) and corresponding training necessary to carry out their jobs effectively.

Whats more, many stakeholders today are multidisciplinary as the integration of commercial, medical, and market access teams continue to proliferate within biopharma companies. This means MSLs must tailor their approach to consider multiple viewpoints within the same conversation. In the same vein, MSLs are becoming more closely involved in understanding unmet patient needs.

Determining influential KOL networks is critical, especially in rare disease. MSLs need to undertake a great deal more research in advance to find out the influencer in these networks, for example, to help determine the patient journey and how these patients are finding experts. The new MSL model involves a patient-centric approach to care since there is a larger network of stakeholders who have shifted to focusing on the patient journey rather than the drug.

How biopharmaceutical companies can support the evolving role of MSLs

To support MSLs in their changing roles, there are measures that biopharmaceutical companies can take. The following are our four recommendations.

Most of the existing MSL training programs focus on clinical aspects and knowledge acquisition. Formalizing these cohort, peer-to-peer types of learning activities within their training plan will enhance the application part of their learning experience, which is often missing.

Supporting the evolution of the MSL

Theres no denying that the role of MSLs is evolving, in particular, due to the industrys increased focus on rare disease and specialty care. MSLs are having more specialized conversations with a dynamic group of stakeholders, bringing crucial insights back to pharmaceutical companies, and playing a pivotal role in the development process.

As more new drugs targeting rare disease enter the market, the MSL function will continue to expand. Companies can support MSLs in this new landscape by providing the tools and training they need to carry out their roles effectively. This should include mapping out dedicated training plans that include peer-based learning, an emphasis on enhancing their emotional intelligence skills, and providing the digital assets needed to enhance important conversations.

With the right training in place, MSLs can play an optimal role in educating and engaging key stakeholders, ultimately leading to improved patient outcomes.

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Supporting and enhancing the evolving role of MSLs PharmaLive - PharmaLive

Clinical Laboratory Tests Market To Witness Revenue Surge Reaching $304.9 Billion By 2027, Driven By Rising Investments in Diagnosing Target Diseases…

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According to a new report published by Grand View Research, increasing prevalence of chronic diseases and rising awareness among health-conscious population have fueled the growth of the global clinical laboratory tests industry.

Clinical Laboratory Tests Industry Overview

The global clinical laboratory tests market size was valued at USD 176.7 billion in 2019 and is expected to reach USD 304.9 billion by 2027, registering a CAGR of 7.1% over the forecast period. Increasing prevalence of chronic diseases and rising awareness among health-conscious population have fueled the growth of the overall market.

The demand for clinical laboratory tests is driven by growing investments in diagnosing target diseases such as cardiovascular disorders, tuberculosis, and diabetes. Clinical laboratory tests help diagnose diabetes mellitus. According to an article published by the International Diabetes Federation in 2019, around 463 million adults were living with diabetes, and by 2045 it is estimated to reach 700 million globally.

Gather more insights about the market drivers, restrains and growth of the Global Clinical Laboratory Tests Market

Increasing geriatric population is anticipated to drive the overall market for clinical laboratory tests. According to the data published by the World Population Prospects: the 2019 Revision, around one in 11 people were aged over 65 years in 2019, and by 2050, it is estimated that approximately one in 6 people in the world will be aged 65 years and above. Clinical laboratory tests are increasingly used to diagnose age-related diseases.

Moreover, growing rate of insufficient exercise, consumption of unhealthy food, and the subsequent rise in cases of obesity are expected to increase the prevalence of various chronic diseases. Rising awareness of the necessity of regular body profiling among healthcare professionals and patients globally is expected to increase the demand for clinical laboratory tests.

Clinical Laboratory Tests Market Segmentation

Based on the Type Insights, the market is segmented into Complete blood count, HGB/HCT, Basic metabolic panel, BUN creatinine tests, Electrolytes testing, HbA1c tests, Comprehensive metabolic panel, Liver panel, Renal panel, Lipid panel.

Based on the End-use Insights, the market is segmented Central Laboratories and Primary Clinics.

Based on the Regional Insights, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Browse through Grand View Researchs Clinical Diagnostics IndustryResearch Reports.

Market Share Insights

Key Companies Profile:

Key companies are focusing on strategic partnerships, mergers, and acquisitions to increase their presence in the market for clinical laboratory tests.

Order a free sample PDF of the Clinical Laboratory Tests Market Intelligence Study, published by Grand View Research.

About Grand View Research

Grand View Research is a full-time market research and consulting company registered in San Francisco, California. The company fully offers market reports, both customized and syndicates, based on intense data analysis. It also offers consulting services to business communities and academic institutions and helps them understand the global and business scenario to a significant extent. The company operates across multitude of domains such as Chemicals, Materials, Food and Beverages, Consumer Goods, Healthcare, and Information Technology to offer consulting services.

Web: https://www.grandviewresearch.com

Media ContactCompany Name: Grand View Research, Inc.Contact Person: Sherry James, Corporate Sales Specialist U.S.A.Email: Send EmailPhone: 1888202951Address:Grand View Research, Inc. 201 Spear Street 1100 San Francisco, CA 94105, United StatesCity: San FranciscoState: CaliforniaCountry: United StatesWebsite: https://www.grandviewresearch.com/industry-analysis/clinical-laboratory-tests-market

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Gut bacteria and stroke: What is the link? – Medical News Today

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Past research links the health of the gut microbiome to various diseases, including inflammatory bowel disease, Alzheimers disease, and kidney disease.

Researchers from the Dr. Israel Fernndez Cadenas (PI) Group Stroke Pharmacogenomics and Genetics Laboratory have uncovered a link between certain bacteria in the gut microbiome associated with more severe stroke and negatively affecting post-stroke recovery.

Researchers presented the study on May 4, 2022, at the 2022 European Stroke Organisation Conference (ESOC).

What is the gut microbiome?

The gut microbiome refers to the trillions of bacteria and other microorganisms living within the intestinal tract of humans. Research shows these good bacteria play an important role in the bodys overall health, including boosting immunity and helping with digestion.

If the gut microbiome becomes unbalanced, it can harm the body. Stress, bad eating habits, and antibiotics can disrupt the gut microbiome. When this happens, the body becomes vulnerable to diseases, including those related to inflammation, such as rheumatoid arthritis and heart disease.

A stroke happens when blood is not able to reach the brain. If blood flow to the brain becomes blocked, oxygen and vital nutrients cannot get to the brain, which can cause brain cells to die.

Data shows that about 13 million people globally experience a stroke each year, and about 5.5 million people die from strokes.

There are two main types of strokes:

In this new study presented at the 2022 European Stroke Organisation Conference, a research team led by Miquel Lleds, lead researcher and Ph.D. student from the Stroke Pharmacogenomics and Genetics Laboratory Group at the Sant Pau Research Institute in Barcelona, Spain, studied fecal samples from 89 ischemic stroke patients.

The influence of the gut microbiome is a modifiable risk factor associated with the risk of stroke and with post-stroke neurological outcomes, Lleds explains. However, most research has previously been done in animal models. In this study, we took (fecal) samples the first samples taken after the event from 89 humans whod suffered an (ischemic) stroke. (Compared) with a control group, we were able to identify multiple groups of bacteria that were associated with a higher risk of (ischemic) stroke.

From their research, scientists identified multiple types of bacteria associated with an increased risk for ischemic stroke, including the bacteria Fusobacterium and Lactobacillus. They also found the bacteria Negativibacillus and Lentisphaeria were associated with a more severe stroke in the acute phase. And the bacteria Acidaminococcus led to poor post-stroke recovery after three months.

Acidaminococcus is an opportunistic pathogen, and this genus has already been related to a higher risk of stroke, Lleds told Medical News Today when asked why Acidaminococcus associates with poor functional outcomes at three months. He added that Acidaminococcus is a member of the family Veillonellaceae, known for producing succinate a compound linked to increased risk factors for cardiovascular disease.

Based on his teams research, Dr. Lleds said research on gut microbiota could have direct and simple applicability in the clinical field. If the evolution of patients with stroke is associated with the presence of a certain type of microbial flora, we could carry out clinical trials varying this microbial composition, he explained.

In other pathologies, clinical trials are being carried out in which researchers replace the intestinal flora through dietary changes or fecal transplantation from healthy individuals much more consistent in the long term, he continued. One way to do that is by using lyophilized compounds of microorganisms in capsules that are easy to ingest and that modify the intestinal flora.

And in regards to post-stroke recovery, Dr. Lleds said there are currently no specific neuroprotective treatments to prevent neurological worsening after stroke. The use of new therapies, such as changes in the microbiome through nutritional changes or fecal transplantation, could be useful to improve post-stroke evolution, he added.

MNT also spoke about this study with Dr. Reza Shahripour, a board certified vascular neurologist at Providence Saint Johns Health Center in Santa Monica, CA. He says the label cryptogenic stroke is used for 30 to 35 percent of stroke cases where there is no known cause for the condition.

We dont know whats the etiology and the patient doesnt have any atherosclerosis disease, no cardioembolic source, he explained. If we believe that inflammation of these kinds of microbes in the gut could be the source of inflammation, we have a reason for that type of stroke.

Additionally, Dr. Shahripour said there are recurrent stroke cases in people taking antiplatelet or anticoagulant drugs.

If there is a risk factor of (the) microbiome in the gut, if we can address it before another stroke, we can decrease the (recurrence) of stroke in the future, he added.

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Gut bacteria and stroke: What is the link? - Medical News Today

2 Out of 3 Women with Depression or Anxiety Say TheyVe Reached Their Breaking Point, Yet More Than Half Wait a Year Before Seeking Treatment -…

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Newswise Two out of three women diagnosed with depression or anxiety say they have reached or are approaching their breaking point regarding their mental health, according to the GeneSightMental Health Monitor, a new nationwide survey from Myriad Genetics, Inc. (NASDAQ: MYGN).

This breaking point can include a negative impact or a significant strain on anything from social life to caring for loved ones at home to professional obligations. Four out of 10 womenwithout a diagnosis ofdepression or anxiety say they have reached or are reaching this point.

When feeling overwhelmed, nearly three in four (72%) of women say they "just need to take a break, with 31% believing I need to try harder. Only 13% said they thought I should see a doctor when feeling overwhelmed.

Women often feel pressure to hold it all together and not admit when they are struggling, says Dr. Betty Jo BJ Fancher, a family medicine and psychiatric physician assistant with a doctorate of medical science and a masters in psychopharmacology. Yet, if you are sobbing on the floor of your shower, throwing things in anger or repeatedly screaming into a pillow, these are signals that you have crossed a line and should see a healthcare provider about your mental health.

Delaying mental health treatment is common among the women surveyed. In fact, more than half (51%) of women diagnosed with anxiety and/or depression waited at least one year before seeking treatment or never sought treatment at all.

The GeneSight Mental Health Monitor found that women are waiting more than a year longer than they should to get the mental health treatment they need, noted Rachael Earls, PhD, a medical science liaison with Myriad Genetics, makers of the GeneSight test. It is critical to receive treatment for mental health because we know that mental health conditions are highly comorbid with other physical diseases, such as cancer, stroke, heart disease. Why live with a mental health condition that can impact every aspect of your life until you reach a breaking point?

According to the survey, the top reasons women diagnosed with depression or anxiety delayed treatment are:

Will my concerns be validated or ignored?

The reluctance by some women to seek treatment may be rooted in how their mental health concerns have been received by family and friends.

Six in 10 of the women surveyed with depression or anxiety diagnosis say they have been ignored or dismissed by family, friends, and/or partners about their mental health concerns. Less than half of women (44%) say they talk to friends or family to relieve stress and anxiety.

I have friends who wont talk to their parents about how they are struggling because they are afraid of their parents reaction, says Ansley, daughter of Dr. Fancher and a senior at the University of Georgia, who has been diagnosed with depression, anxiety and ADHD. Therapy has helped me, so I know the benefits of talking to someone about your mental health. When friends or classmates say they are suffering with depression or anxiety, I encourage them to reach out to someone and get the help they need.

Despite available treatment options, fewer than two in 10 women believe they will ever be free from anxiety or depression symptoms.

Getting personalized treatment

Six in 10 women diagnosed with depression or anxiety agree that taking a prescription medication was the most helpful step in treating their anxiety or depression symptoms, more than any other action or treatment option offered in the survey, including therapy.

Only about 30% of women who have been prescribed psychiatric medication are aware of genetic testing that may help their physicians with prescribing decisions and only 8% of these respondents have had genetic testing. Yet, 67% of diagnosed women whose doctor didnotuse genetic testingsaid they wish their doctor had told them about and/or offered a genetic test that could provide information about how their genes may affect medication outcomes.

Dr. Fancher orders the GeneSight test to get personalized genetic information about her patients that helps her understand how they may metabolize or respond to certain medications commonly used to treat depression, anxiety, ADHD and other mental health conditions.

Having the genetic information from the GeneSight test at my fingertips to help inform my medication selection makes me a better provider, said Dr. Fancher.

Ansleys mental health provider also uses the GeneSight test. She made adjustments based on my results, and I am happy to say that everything is working really well, said Ansley.

For more information on how genetic testing can help inform clinicians on treatment of depression, anxiety, ADHD, and other psychiatric conditions, please visitGeneSight.com. To download graphics, a multimedia video and other information regarding the survey, please visitGeneSight.com/Mental-Health-Monitor.

About the GeneSightMental Health MonitorThe GeneSight Mental Health Monitor is a nationwide survey of U.S. adults conducted online by ACUPOLL Precision Research, Inc. from Feb. 25 March 11, 2022, among a statistically representative sample (n=1000) of adults age 18+. The survey included a representative sample of women diagnosed with depression and anxiety. The margin of error in survey results for the total base population at a 95% confidence interval is +/- 3%.

About the GeneSight TestThe GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for 64 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The GeneSight test can help inform clinicians about how a patients genes may impact how they metabolize and/or respond to certain psychiatric medications. It has been given to more than 1.5 million patients by tens of thousands of clinicians to provide genetic information that is unique to each patient. The GeneSight test supplements other information considered by a clinician as part of a comprehensive medical assessment. Learn more atGeneSight.com.

About Myriad GeneticsMyriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs.Fast Companynamed Myriad among the Worlds Most Innovative Companies for 2022. For more information, visitwww.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, Colaris AP, MyRisk, Myriad MyRisk, MyRisk Hereditary Cancer, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Precise, FirstGene, Health.Illuminated., RiskScore, Prolaris, GeneSight, and EndoPredict are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries.

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