NinePoint Medical Initiates Clinical Trial of Nvision VLE Imaging System; Program On Track for Commercial Launch in 2013

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, today announced that the company has initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using its proprietary Nvision VLE Imaging System, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this year. NinePoint Medical also announced the expansion of its executive leadership team with the appointment of Patrick MacCarthy to vice president of marketing.

The single-arm, open-label observational trial is designed to evaluate the performance of the Nvision VLE Imaging System to visualize subsurface tissue in patients undergoing esophagogastroduoenoscopy (EGD) for suspected or confirmed Barrett’s esophagus, a condition that is one of the most common precursors to esophageal cancer. The trial is expected to enroll approximately 100 patients at five leading centers worldwide, including the Mayo Clinic in Jacksonville, Fla. and Rochester, Minn.; Kansas University Medical Center in Kansas City, Mo.; Academic Medical Center in Amsterdam; University College London; and University Hospital in Nantes, France.

In January, NinePoint Medical announced 510(k) clearance from the FDA to market its Nvision VLE Imaging System for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. The Nvision VLE Imaging System is a next-generation optical imaging technology designed to enable physicians and pathologists, for the first time, to view high-resolution, volumetric images of organs and tissues in real time. The Nvision VLE Imaging System is the first volumetric optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging that uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real time.

“The Nvision VLE Imaging System has the potential to improve and accelerate the diagnosis and treatment of patients with potentially diseased tissues, including gastrointestinal conditions like Barrett’s esophagus, by providing physicians with high-resolution, volumetric images in real time,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “We have made rapid and significant progress in advancing the development of this technology, including 510(k) clearance from the FDA for a general indication and the initiation of this clinical trial for use in patients with Barrett’s esophagus as planned. We also are pleased to welcome Patrick to our team at this pivotal time. His broad medical device expertise will be invaluable as we continue to strengthen our management team and prepare for the commercial launch of the Nvision VLE Imaging System next year.”

Mr. MacCarthy brings to NinePoint Medical more than 10 years of marketing and sales expertise within the medical device and technology sectors. Mr. MacCarthy joins NinePoint Medical from Olympus America, Inc., where he was an integral member of the leadership team for Olympus’ flagship medical device and equipment business. Most recently, Mr. MacCarthy was vice president of marketing, responsible for marketing and strategic planning in the endoscopy division. Prior to that, he held positions of increasing responsibility at Olympus, including vice president / business unit leader and executive director of marketing, both in the endotherapy division. Mr. MacCarthy holds a Bachelor of Science in mechanical engineering from Colorado School of Mines.

For more information on NinePoint Medical’s clinical trial, please visit http://www.clinicaltrials.gov.

About NinePoint Medical, Inc.

NinePoint Medical, Inc. is a transformational medical device company developing innovative, real-time, in vivo pathology devices focused on dramatically improving patient care. Through its proprietary Nvision VLE Imaging System, NinePoint intends to bridge the gap between the diagnosis and treatment of disease. The Nvision VLE Imaging System will enable physicians and pathologists, for the first time, to view real-time, high-resolution, volumetric images of organs and tissues up to 3mm deep at less than 10 micron resolution. Initially, NinePoint is focusing on devices that enable real-time, endoscopic screening and surveillance of diseases of the mucosa of various tissues that are often precancerous. Eventually, the company intends to develop medical devices that provide physicians with immediately actionable information, which will allow them to diagnose and treat patients during the same procedure. This convergence of access, diagnosis and treatment during one procedure is expected to improve patient experiences and outcomes, improve the efficiency of care and provide important savings to the health care system. Headquartered in Cambridge, Mass., NinePoint is backed by Third Rock Ventures and Prospect Venture Partners. For more information, please visit http://www.ninepointmedical.com.

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NinePoint Medical Initiates Clinical Trial of Nvision VLE Imaging System; Program On Track for Commercial Launch in 2013

New Pattern Identifies Cells That Pose Risk of Tumors in Gonadal Dysgenesis Patients

Newswise — Pediatric and Developmental Pathology – Gonadal dysgenesis—defective development of the ovaries or testes— may also bring with it an increased risk of gonadal tumors. A recent discovery at the histologic level could help identify cells at risk of conversion into a tumor. For patients with XY gonadal dysgenesis, this means earlier detection and treatment of tumors.

A study in the current issue of the journal Pediatric and Developmental Pathology retrospectively examined gonads from 30 patients with gonadal dysgenesis. Cytogenic analyses were performed, investigating specifically the role of a primitive tissue known as “undifferentiated gonadal tissue.”

The complex processes of sexual development and differentiation into male or female can be disrupted in many ways. Pure, or complete, gonadal dysgenesis and mixed gonadal dysgenesis are among the most frequently occurring of these disorders. X/XY gonadal mosaicism, has been shown to play a role in disorders of sexual differentiation.

Undifferentiated gonadal tissue describes the presence of persistent primitive sex cords containing immature germ cells. These immature germ cells represent a risk factor for gonadal tumors. They hold the possibility of neoplastic transformation into a tumor.

The authors advise that germ cells in gonadal streaks should not be overlooked. Of 13 gonads in this study that were found to have both undifferentiated gonadal tissue and a streak, 9 developed a tumor.

About 30 percent of patients with pure gonadal dysgenesis, and 15 percent with mixed gonadal dysgenesis go on to develop gonadal tumors. These are mostly ganodoblastomas, which are benign, but in 60 percent of these cases, the patients may develop malignant tumors. Finding the etiology of these neoplasms is an essential step in stopping their development.

Full text of the article, “Undifferentiated Gonadal Tissue, Y Chromosome Instability, and Tumors in XY Gonadal Dysgenesis,” Pediatric and Developmental Pathology, Vol. 14, No. 6, 2011, is available at http://www.pedpath.org/toc/pdpa/14/6.

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New Pattern Identifies Cells That Pose Risk of Tumors in Gonadal Dysgenesis Patients

Research and Markets: The Evolving Field of Digital Pathology – Digital Health NOW Spotlight Report

DUBLIN--(BUSINESS WIRE)--

Research and Markets(http://www.researchandmarkets.com/research/548166/digital_health_now) has announced the addition of the "Digital Health NOW Spotlight Report: The Evolving Field of Digital Pathology" report to their offering.

Digital pathology is a disruptive technology; however, the consensus is that digital pathology is clearly our future. This iteration of Branham's Digital Health NOW Spotlight report takes a look at the emerging Digital Pathology market segment in health care. The report provides an overview and a general understanding of Digital Pathology rather than a detailed discussion of underlying technologies and vendors.

Digital pathology is rapidly gaining momentum as a proven and essential technology that is helping to reduce laboratory expenses, improve operational efficiency, enhance productivity and improve treatment decisions and patient care. It is used worldwide in drug development, reference lab, hospital, and academic medical centre settings. Applications include education, research, image analysis, archival and retrieval, LIS/LIMS integration, secondary consultations and virtual slide sharing. However, widespread adoption of digital pathology has been hindered not only by cost and technical factors but also largely by the mind set of technophobic pathologists.

Key Topics Covered:

What is Digital Pathology?

Steps in Digital Pathology Scanning Quantitative Analysis and Computer-Assisted Image Data Mining Pathology Image Management and Storage

Benefits of Digital Pathology

Dramatic Reduction in Misdiagnosis Remote Diagnosis and Support Educational Benefi ts

Market Trends

Evolving Market Validation is Still Incomplete Archival and Retrieval Systems Regulatory Challenges Sluggish Growth Lack of Standards Telepathology Vendor Landscape

Final Thoughts

For more information visit http://www.researchandmarkets.com/research/548166/digital_health_now

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Research and Markets: The Evolving Field of Digital Pathology - Digital Health NOW Spotlight Report

Sonic Healthcare grabs market share

SONIC Healthcare lifted first half profit by eight per cent to $146 million as it continues to take a greater share of the market despite global uncertainty.

 The pathology and radiology provider said its net profit after tax was $146 million in the six months to December 31, 2011, up eight per cent from $143 million in the prior corresponding period.

Revenue was $1.69 billion, up 12 per cent from $1.64 billion over the same period last year.

Earnings before interest, taxes, depreciation, and amortisation (EBITDA) during the six months were $304 million, up 14 per cent from $297 million.

The company declared a 24 per cent dividend per share which was unchanged from the prior year. The dividend was 35 per cent franked.

The company also said it was on track to achieve its full-year guidance of 10 to 15 per cent earnings growth.

Chief executive Colin Goldschmidt on Tuesday said ongoing headwinds from the strong Australian dollar had softened the company's results but did not affect underlying performance.

"In a time of global uncertainty and weak economic conditions, Sonic's operations continue to perform strongly, taking market share from competitors and increasing margins through synergy capture, tight cost control and revenue growth,'' Mr Goldschmidt said in a statement.

Sonic's Australian Pathology operations have continued the turnaround which began in the second half of the 2011 financial year.

Mr Goldschmidt said the company recorded revenue growth of eight per cent and more than 150 basis points of margin improvement.

The company said it was pleased with the outcome in a market still challenged by high collection costs as a result of changes to the regulations around collection centres.

"Our focus on quality, customer service and brand strength have enabled us to grow market share despite opening proportionately fewer collection centres than others,'' he said.

Sonic's pathology operations in Germany were a standout performer and the company's other European pathology operations, including the radiology division and IPN, had also performed strongly during the half year.

The company's businesses in Belgium, Switzerland, the UK and Ireland were tracking well.

However, all US laboratory companies had been affected by the weak US economy, causing low to flat organic revenue growth, Sonic said.

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Sonic Healthcare grabs market share

Sonic posts 8pc rise in first half profit

SONIC Healthcare Ltd has posted an eight per cent increase in first half profit as it continues to take a greater share of the market despite global uncertainty.

The pathology and radiology provider said its net profit after tax was $146 million in the six months to December 31, 2011, up eight per cent from $143 million in the prior corresponding period.

Revenue was $1.69 billion, up 12 per cent from $1.64 billion over the same period last year.

Earnings before interest, taxes, depreciation, and amortisation (EBITDA) during the six months were $304 million, up 14 per cent from $297 million.

The company declared a 24 per cent dividend per share which was unchanged from the prior year. The dividend was 35 per cent franked.

The company also said it was on track to achieve its full-year guidance of 10 to 15 per cent earnings growth.

Chief executive Colin Goldschmidt today said ongoing headwinds from the strong Australian dollar had softened the company's results but did not affect underlying performance.

"In a time of global uncertainty and weak economic conditions, Sonic's operations continue to perform strongly, taking market share from competitors and increasing margins through synergy capture, tight cost control and revenue growth," Mr Goldschmidt said in a statement.

Sonic's Australian Pathology operations have continued the turnaround which began in the second half of the 2011 financial year.

Mr Goldschmidt said the company recorded revenue growth of eight per cent and more than 150 basis points of margin improvement.

The company said it was pleased with the outcome in a market still challenged by high collection costs as a result of changes to the regulations around collection centres.

"Our focus on quality, customer service and brand strength have enabled us to grow market share despite opening proportionately fewer collection centres than others," he said.

Sonic's pathology operations in Germany were a standout performer and the company's other European pathology operations, including the radiology division and IPN, had also performed strongly during the half year.

The company's businesses in Belgium, Switzerland, the UK and Ireland were tracking well.

However, all US laboratory companies had been affected by the weak US economy, causing low to flat organic revenue growth, Sonic said.

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Sonic posts 8pc rise in first half profit

Sonic sounds depths of growth

Testing times: But Sonic Healthcare is still growing strong. Photo: Jim Rice

PATHOLOGY and radiology group Sonic Healthcare expects to hit its full-year pre-tax earnings target of 10-15 per cent growth as it reaps the rewards of strong organic revenue growth, market share gains in Australia and margin expansion in Germany.

Sonic also says it will expand its margins in North America where its business has increased market share despite the weak economic environment.

Chief executive Colin Goldschmidt said yesterday pathology was an ''absolute essential service'' in the healthcare sector and Sonic had incredible infrastructure in Australia, Germany and the US.

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''It really is a very nice position to be in going into the future, despite the uncertainties of the global climate et cetera,'' Dr Goldschmidt said. ''It's a sector that tends to be shielded in some way from some of the downturns that occur in other sectors because it is an essential service.''

Sonic, which also has healthcare businesses in New Zealand, Belgium and Switzerland, has posted a 6 per cent lift in interim net profit to $143 million, or in constant-currency terms up 8 per cent to $146 million.

Statutory revenue was 9 per cent better at $1.64 billion, but up 12 per cent to $1.69 billion in constant-currency terms.

The company has declared an interim dividend of 24¢ a share, which is unchanged from the previous year.

Dr Goldschmidt said headwinds from the strong Australian dollar had softened the company's results, but did not affect underlying performance.

''In a time of global uncertainty and weak economic conditions, Sonic's operations continue to perform strongly, taking market share from competitors and increasing margins,'' Dr Goldschmidt said.

Sonic was on track to deliver growth in earnings before interest, tax, depreciation and amortisation of 10-15 per cent over the 2010-11 level of $570 million, he said.

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Sonic sounds depths of growth

Sonic in nice position for future growth

Pathology and radiology provider Sonic Healthcare Ltd says it's well positioned to deliver essential services and increase its market share despite global uncertainty.

Sonic posted an eight per cent increase in first half profit on Tuesday and said it was on track to achieve its full-year guidance of 10 to 15 per cent earnings growth.

Chief executive Colin Goldschmidt said pathology was an 'absolute essential service' in the healthcare sector and Sonic had incredible infrastructure in the important markets of Australia, Germany and the USA.

'It really is a very nice position to be in going into the future, despite the uncertainties of the global climate etc,' Mr Goldschmidt told analysts in a briefing.

'It's a sector that tends to be shielded in some way from some of the downturns that occur in other sectors because it is an essential service.'

He said the Australian division was performing exceptionally well even though it had opened fewer collection centres than its competitors.

But he admitted the biggest drag on the company's growth was its US laboratory business which had been affected by the weak US economy.

Sonic Healthcare said its net profit after tax was $146 million in the six months to December 31, 2011, up eight per cent from $143 million in the prior corresponding period.

Mr Goldschmidt said ongoing headwinds from the strong Australian dollar had softened the company's results but did not affect underlying performance.

'In a time of global uncertainty and weak economic conditions, Sonic's operations continue to perform strongly, taking market share from competitors and increasing margins,' Mr Goldschmidt said.

Sonic's Australian Pathology operations have continued the turnaround which began in the second half of the 2011 financial year.

It comes as the company recorded revenue growth of eight per cent and more than 150 basis points of margin improvement.

The company said it was pleased with the outcome in a market still challenged by high collection costs as a result of changes to the regulations around collection centres.

Sonic's pathology operations in Germany were a standout performer and the company's other European pathology operations, including the radiology division and IPN, had also performed strongly during the half year.

The company's businesses in Belgium, Switzerland, the UK and Ireland were tracking well because they were not too exposed to the ongoing downturn in Europe.

Overall revenue was $1.69 billion, up 12 per cent from $1.64 billion over the same period last year.

The company declared a 24 per cent dividend per share which was unchanged from the prior year. The dividend was 35 per cent franked.

Sonic shares were 12 cents, or 1.08 per cent, higher at $11.27 at 1404.

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Sonic in nice position for future growth

Pathology – Code Injection – Video

28-02-2011 18:09 Matti Way - Vocals Tim Tiszczenko - Guitar Oscar Ramirez - Bass Dave Astor - Drums ***************************** Infected by will saliva will secrete DNA strands complete Living cells evolve and mutate Brain neurons regenerate A war of consciousness A war of our minds Accounts of the elders Guards of forbidden knowledge An ancient race will rise Reality is only what we perceive Operation majority directs all technology Collected to advance through the stars Code Injection The Jason Society 32 strong Designate lies and deception of truth and control Code inject - Code inject - Code inject - Code inject Sigma is responsible with communications With the beyond... Infected by will control is complete DNA strands - Maji Dead cells evolve and mutate Brain experiment delete A war of consciousness A war on our minds

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Pathology - Code Injection - Video

What Does A Breast Cancer Pathologist Do? – Dr. Jay K. Harness – Video

07-11-2011 16:34 Click Here To Get Dr. Harness' 15 Breast Cancer Questions To Ask Your Doctor http://www.breastcanceranswers.com Breast Cancer Answers is a social media show where viewers submit a question and get the answer from an expert. Submit your question now at, ?www.breastcanceranswers.com In this clip, Jay Harness, MD, FACS explains what a pathologist does. A pathologist is a critical and key member of the team that treats breast cancer. Pathologists are physicians. They have been trained to dissect and analyze tissue that's been removed from the body or blood, for that matter. Pathologists are critical in breast cancer, and having expert pathologist in breast cancer is very, very important because there are many subtleties in the diagnosis of breast cancer, and so having a well-trained pathologist is important. In the operating room everyday, I am working with a pathologist. I may send a lump over for the pathologist to visually look at and tell me that the tissue around the lump is okay. Pathologists are involved when I am operating and doing frozen sections, which is a wrap and analysis of lymph nodes, and let me know if they are involved or not. The final pathology report is what's key in the final staging of breast cancer. So is my breast cancer stage-1, or stage-2, or whatever it is, and determining the extent of the breast cancer within the breast is a critical duty of the pathologist and the physician's assistants who work with pathologists. This information should not be relied ...

Continued here:
What Does A Breast Cancer Pathologist Do? - Dr. Jay K. Harness - Video

New clinic to speed up advice

Educator Kathy Harrison helps her patients manage diabetes at the new QML Pathology care clinic.

Sarah Harvey

A NEW diabetes care clinic in Ipswich will help cut the average six-month wait for patients needing to see an educator.

QML Pathology has opened several fully bulk-billed clinics around Queensland to meet the demand for treatment relating to Australia's fastest growing chronic disease.

Medical director Dr Debra Norris said the clinics would dramatically slash waiting times for both new and existing patients.

"QML's diabetes care clinics will provide welcome relief for the public health system," Dr Norris said.

"Working in collaboration with the patient's own GP, early action following a diagnosis is crucial to a patient's long-term health.

"All new patients can be seen within two weeks, with priority given to newly diagnosed patients.

"This is great news for the one in 10 Queenslanders who suffer from diabetes."

Credentialed diabetes educator Kathy Harrison has been working with QML Pathology for more than 12 months.

Ms Harrison has noticed that younger patients are developing diabetes.

"I've seen people in their 20s," she said.

"It's not just because of diet - it's family and history.

"There are a lot of complications with untreated diabetes.

"It's one of the leading causes of blindness, and the risk of heart disease and stroke increases."

Ms Harrison said men and women with type 2 diabetes might not have symptoms, or be sick enough to go to their doctor.

"People with type 2 diabetes, they account for 85% of people we see," she said.

"Diabetes is problems to do with your insulin. There are lots of treatment options. We can help them manage it easily.

"Our patients are referred by the GP and at our first meeting we will run through their medical background, look at their glucose levels and pathology tests.

"For newly diagnosed patients, we'll answer any questions and ensure they are equipped with all the information they need to manage their condition."

For details about the diabetes care clinics, visit diabetes.medway.com.au or phone 5441 0200.

FAST FACTS

An estimated 275 Australians develop diabetes every day. Almost one million Australians are currently diagnosed with diabetes. Up to 60% of type 2 diabetes cases can be prevented. Diabetes is the sixth leading cause of death in Australia. Symptoms include frequent urination and tiredness.

Original post:
New clinic to speed up advice

Bristol Evening Post commented Wrong diagnoses by Bristol’s pathology service ‘could hit 6,800’

WHISTLEBLOWERS claim they may have exposed the full scale of the number of serious errors made by Bristol's pathology service.

The South West Whistleblowers Health Action Group believes as many as 6,800 patients may have been wrongly diagnosed when their tissue samples were tested for cancer and other diseases at the Bristol Royal Infirmary between 2000 and 2008.

Former breast cancer patient Daphne Havercroft, who leads the South West Whistleblowers Health Action Group

The group claims the true scale of the mix-ups in diagnosis were not made clear in a report published in December 2010, at the end of an 18-month inquiry into the hospital's histopathology service.

The inquiry concluded that while there were some serious errors in diagnosis there was no evidence to show that the hospital did not offer a safe service.

Independent doctors reviewed 26 specific allegations of misdiagnosis, and found only three of the samples represented serious errors. However, the whistleblowers' group says it has now discovered more figures in an annexe to the inquiry's report.

The group says there is an admission that an audit of a further 3,500 cases found that in 3.4 per cent of them independent pathologists who re-examined the samples believed the wrong diagnosis had been made. With the hospital examining more than 20,000 specimens a year, the figure could represent up to 6,800 errors over a decade.

Among the tissue samples wrongly diagnosed were those of Catherine Calland, of Hotwells, who is now terminally ill after her cancer was missed.

Former breast cancer patient Daphne Havercroft, left, who leads the whistleblowers' group, has written a letter to the chairman of the inquiry to question the figures. She fears plans to merge the BRI's pathology service with services across the city at Southmead Hospital could put a larger population at risk.

Ms Havercroft believes the problems at the pathology service have still not been properly investigated.

She said: "We think patients are being put at risk. If we get expert evidence to say that the figures we have come up with are wrong, then that's fine.

"We are saying 'This is our hypothesis – can you disprove it?'"

University Hospitals Bristol NHS Foundation Trust, which runs the BRI, told a national newspaper that it had accepted the inquiry's findings and focused on implementing the recommendations. A spokesman said the inquiry's independent panel found no evidence to suggest the department was not safe.

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Bristol Evening Post commented Wrong diagnoses by Bristol's pathology service 'could hit 6,800'

Dako Enters into an Additional Collaboration with Amgen on Developing a Companion Diagnostic Test (pharmDxTM) for an …

GLOSTRUP, DENMARK--(Marketwire -02/20/12)- Dako, a world leading independent cancer diagnostic supplier with 45 years of experience in pathology, announced today that it has entered into a new collaboration agreement with Amgen Inc. (NASDAQ: AMGN - News) on the development of a diagnostic test for an Amgen cancer drug candidate in clinical development.

"It is Dako's mission to fight cancer. Hence, we are pleased to be chosen as Amgen's partner once again for the development of companion diagnostics linked to Amgen's investigational targeted therapies," says Lars Holmkvist, Dako's chief executive officer.

In January 2012, Dako announced a collaboration agreement with Amgen Inc. introducing a new business model which supports the concurrent development of drug and diagnostics for a rare but deadly cancer - something that up to this point has been difficult to achieve in the industry.

"This new collaboration with Amgen underlines Dako's commitment to advance personalized medicine in cancer treatment as the selection of patients most likely to benefit from a specific treatment will increase the probability of therapeutic success for cancer patients suffering," Lars Holmkvist adds.

Today's news comes on the heels of several pharmDx™ collaborative agreements recently announced by Dako.

The demand for personalized medicine is increasing with the recognition that it may provide a way to improve patient care and manage healthcare costs by targeting treatments to individuals more likely to benefit from specific therapies.

About Dako

Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako's know-how, reagents, instruments and software to make accurate diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1,000 people and being present in more than 80 countries, Dako covers essentially all of the anatomic pathology markets globally. Dako is owned by private equity fund EQT V. http://www.dako.com

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Dako Denmark A/S via Thomson Reuters ONE

[HUG#1587603]

Original post:
Dako Enters into an Additional Collaboration with Amgen on Developing a Companion Diagnostic Test (pharmDxTM) for an ...

Bristol Evening Post published Wrong diagnoses ‘could hit 6,800’

WHISTLEBLOWERS claim they may have exposed the full scale of the number of serious errors made by Bristol's pathology service.

The South West Whistleblowers Health Action Group believes as many as 6,800 patients may have been wrongly diagnosed when their tissue samples were tested for cancer and other diseases at the Bristol Royal Infirmary between 2000 and 2008.

Former breast cancer patient Daphne Havercroft, who leads the South West Whistleblowers Health Action Group

The group claims the true scale of the mix-ups in diagnosis were not made clear in a report published in December 2010, at the end of an 18-month inquiry into the hospital's histopathology service.

The inquiry concluded that while there were some serious errors in diagnosis there was no evidence to show that the hospital did not offer a safe service.

Independent doctors reviewed 26 specific allegations of misdiagnosis, and found only three of the samples represented serious errors. However, the whistleblowers' group says it has now discovered more figures in an annexe to the inquiry's report.

The group says there is an admission that an audit of a further 3,500 cases found that in 3.4 per cent of them independent pathologists who re-examined the samples believed the wrong diagnosis had been made. With the hospital examining more than 20,000 specimens a year, the figure could represent up to 6,800 errors over a decade.

Among the tissue samples wrongly diagnosed were those of Catherine Calland, of Hotwells, who is now terminally ill after her cancer was missed.

Former breast cancer patient Daphne Havercroft, left, who leads the whistleblowers' group, has written a letter to the chairman of the inquiry to question the figures. She fears plans to merge the BRI's pathology service with services across the city at Southmead Hospital could put a larger population at risk.

Ms Havercroft believes the problems at the pathology service have still not been properly investigated.

She said: "We think patients are being put at risk. If we get expert evidence to say that the figures we have come up with are wrong, then that's fine.

"We are saying 'This is our hypothesis – can you disprove it?'"

University Hospitals Bristol NHS Foundation Trust, which runs the BRI, told a national newspaper that it had accepted the inquiry's findings and focused on implementing the recommendations. A spokesman said the inquiry's independent panel found no evidence to suggest the department was not safe.

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Bristol Evening Post published Wrong diagnoses 'could hit 6,800'

CBLPath Offers Only FDA-Approved BRAF Companion Diagnostic In-House After Approval From New York State Department of Health

Test Determines Which Melanoma Patients Are Candidates for Zelboraf(R)

  RYE BROOK, NY, Feb 16, 2012 (MARKETWIRE via COMTEX) --
CBLPath announced that it received approval from the New York State Department of Health to perform in-house the cobas(R) 4800 BRAF V600 Mutation Test for metastatic melanoma.
The laboratory is one of a few in the U.S. that is offering the test.

The BRAF V600 companion diagnostic is the sole test approved by the U.S. Food and Drug Administration (FDA) for Zelboraf(R) (vemurafenib), and aids physicians in making the best treatment decisions for patients with inoperable or metastatic melanoma who may be candidates for the drug.

The test detects the BRAF V600E mutation in the BRAF proto-oncogene from human melanoma tumor specimens, which is necessary to identify patients who are eligible for Zelboraf treatment. About half of all melanoma patients test positive for the BRAF mutation. BRAF V600 has shown improved sensitivity and accuracy when compared to other commonly used, unapproved detection methods.

"The approval by the State of New York provides CBLPath with a state-of-the-art diagnostic tool designed to deliver more timely, expert medical care to melanoma patients not only in New York, but also across the country," said Chief Medical Officer Carlos D. Urmacher, M.D., FCAP, FASCP. "It's another step in CBLPath's commitment to remain at the forefront of personalized medicine tailoring healthcare practices to individual patients. By offering tests such as this, we truly help to make a qualitative difference in patients' lives."

Melanoma is the deadliest and most aggressive form of skin cancer. Only modest response rates are typically seen with treatment options available for patients with advanced melanoma. Zelboraf provides a new and more effective treatment for late-stage melanoma, and works by inhibiting the mutated form of BRAF protein. It is the first and only FDA-approved targeted therapy shown to improve survival in patients with BRAF V600E mutation-positive metastatic melanoma.

FDA approval was given to Roche Molecular Systems for the new cobas 4800 BRAF V600 Mutation Test and concurrently to Genentech, a member of the Roche Group, for Zelboraf. CBLPath is offering the test through its affiliation with Roche Diagnostics.

 

Source:
http://feeds.feedburner.com/DigitalPathologyBlog

Back to the Future: Video Telepathology

 

Btfstill

The following non-bolded text that appears are excerpts from an upcoming book chapter to be published shortly.  

Preparation for the book chapter pre-dated now a couple of looks at Remote Meeting Technologies "Anytime, anywhere, anything!" technology that makes the claim "No specimen is too big or too small for iMedHD™ and our Be There Anywhere™ telemedicine solutions. Even gross specimens, autopsy, gram stains, and transbronchial needle aspirations can be safely and securely broadcasted to another location on site, across town, across the country, or across the world! The compact iMedHD™ is the ideal solution for cost effective, real-time High Definition sharing of images over the internet. iMedHD™ is compatible, flexible, and will enable collaboration on multiple applications throughout the pathology department and laboratories including Consultations, Gross, Intraoperative, Tumor Boards and FNA & TBNA".

Reviewing slides and gross images in high-definition got me to thinking about the first experiences with telepathology and video microsocopy: 

Telepathology is the practice of pathology at a distance, obtaining macroscopic and/or microscopic images for transmission along telecommunication links with remote interpretations (telediagnosis), second opinions or consultations (teleconsultation), and/or for educational purposes. “Tele” is a Greek prefix that means “distant.” Various terms that have been used in conjunction with telepathology include digital microscopy, remote robotic microscopy, teleconferencing, teleconsultation, telemicroscopy, video microscopy, virtual microscopy, and whole slide imaging. In the practice of telepathology, the original material (tissue, glass histology slide, etc) is separated by distance from the remote consultant (telepathologist). Remotely viewed digital or analog images, or digital whole slides, get interpreted by the telepathologist on a computer monitor (or even a cell phone screen) rather than through conventional light microscope eyepieces. Today, virtually ubiquitous access to the Internet, or to other broadband telecommunications linkages, on many continents, facilitates nearly global image sharing. As a result, telepathology has been used to aid a growing number of laboratories in providing pathology services over great distances, and has even been used by others to increase the efficiency of services between hospitals less than a mile apart.

With increasing sub-specialization in pathology, the use of telepathology to access subspecialists (e.g. neuropathologists, dermatopathologists) is also on the upswing and is proving to be cost-effective in at least certain settings. The practice of telepathology is not only limited to rendering diagnoses, but can also play important roles in quality assurance (e.g. re-review of cases), teaching, and research. When telepathology is widely viewed as an acceptable ancillary technique, it will likely become a common tool integrated into mainstream diagnostic pathology.

Pathology and oncology, just as the rest of medicine is becoming increasingly subspecialized, particularly in community settings.

Dr. Ron Weinstein introduced the term “telepathology” into the English language in 1986. In the late 1960’s, he was a pathology resident at the Massachusetts General Hospital (MGH) when the first real-time “television microscopy” service was established between the Logan Airport Medical Station and the MGH in Boston, Massachusetts.  He observed early demonstrations of the technology and became aware of the limitations of video microscopy when microscopic field selection was performed by a nurse or a medical technologist at the Logan Airport clinic.  The vast majority of cases did not require an on-site pathologist, since most of the clinical cases involved remotely viewing blood smears and urines. This Logan Airport television microscopy system was not used for surgical pathology cases.

Nearly two decades later, Weinstein differentiated video microscope technologies, including “television microscopy” and “video microscopy,” from “telepathology” for good reason. He proposed that the “practice of telepathology” would require that a “telepathologist”, who would be rendering a telediagnosis, should be able to control remotely all relevant light microscope functions (e.g., using a motorized, robotically controlled light microscope) in order to use telepathology for surgical pathology cases.  Ideally, selection of the diagnostic microscopic fields would be made by the remote telepathologist, using some type of dynamic telepathology system that would accentuate inclusive microscope field selection at a range of viewing magnifications.

Now, thanks to Remote Meeting Technologies, true high-definition, brilliant color, high-definition video is possible for pathology for both gross and microscopic imaging.  True 1920 x 1080p resolution shared very quickly over standard networks. 

No scanning, uploading or downloading required.  Point-to-point connectivity with browser-based viewer for ease of use and easy to control.  

Perfect technology for remote consultations, frozen sections, cytology evaluations, gross review at a distance, etc...

This is not to suggest you can avoid purchasing a whole slide scanner as well for the complete imaging platform but I think there is going to be a renewed trend towards live non-robotic imaging between pathologists, although the lack of stitching here to create an image is a nice point from the regulatory perspective, like, not subject to it...

True 1080p microscopy to share with colleagues, cinicians and patients with brilliant monitors to show every detail.  

If you are looking for real-time imaging with high-def video, check out Remote Meeting Technologies.  Combined with very low-cost high-speed networks you can share diagnostic quality images quickly and easily.

So now, more than 25 years after the first telepathology demonstration in this country, forget about low resolution of 300 lines over expensive satellite networks and the like,  and see pathology in high-definition.

It is fun to look back and to the future.  What will the next generation of this latest technology look like? Perhaps teleport to the bedside without the Delorean?

Back-tofuture-delorean-660

 

Telepathology became a newsworthy item in 1986 with the first public demonstration of a satellite-linked color-video dynamic telepathology system. Fort William Beaumont Army Medical Center in El Paso, Texas, and Washington DC were linked for the demonstration. The dynamic-robotic telepathology system used for the demonstration was designed and fabricated by Weinstein’s group at Rush Medical College, in Chicago in partnership with Corabi International Telemetrics, Inc., a Rush University spin-off company located in a nearby Illinois state-owned biotechnology incubator facility, in west Chicago. The Corabi patented technology combined the use of digital and analog video imaging for the first time. Digital imaging was used to produce a small tissue map, which was captured and displayed, in a low resolution digital image format, on a navigation system monitor. This auxiliary imaging system was used by the remote telepathologist to manage the robotic motorized microscope’s functions. The telepathologist always knew exactly where the motorized microscope’s objective was positioned in relation to the actual tissue section mounted on the glass slide.  Use of the auxiliary navigation system also helped ensure that each entire slide was imaged by the telepathologist-system operator in the course of a telepathology diagnostic session. The magnitude and expense of the effort to create this external navigation system reflected Weinstein’s high level of concern that the Achilles heel of telepathology could turn out to be inadequate histopathology image sampling. His concern proved to be well founded as “limiting sampling” static image telepathology (i.e., sampling of one or only a few fields), was practiced in early commercial static image telepathology systems. Such systems are no longer marketed in the United States. Real-time analog imaging was used for viewing the images of the slide during the diagnostic session in the Texas-Washington, D.C. robotic telepathology demonstration. 

The story appeared on page 7 of the Metro section in the Washington Post:

Nextbestthingtobeingthere

 

For the actual Texas-to-Washington, D.C. proof-of-concept demonstration of robotic-dynamic telepathology, a histopathology slide of a hematoxylin and eosin (H&E)-stained breast frozen section, was processed into a low resolution whole slide digital image, using a low resolution camera mounted on a light box. After the navigation system digital slide was produced, the same breast tissue frozen section slide was remounted on the stage of an Olympus remotely controllable motorized photo-microscope. A stream of analog video images, viewed on a larger monitor, was used for rendering the diagnosis. The analog video images were transmitted, via satellite, to the boardroom of COMSAT Corporation, in Washington, D.C. A telepathologist, Dr. Alexander Miller, seated at a Corabi prototype workstation, was able to control all of the functions of the motorized microscope in Texas, including stage movements, magnification, focus and illumination, while viewing the real-time images, at 525 lines of resolution, with a video monitor refresh rate of 30 frames per second. The navigation system, positioned near the large video monitor, displayed tissue mapping parameters.  Superimposed over the low resolution digital image of the breast frozen section, displayed on the navigation system screen, was a small box-shaped icon indicating the location and size of the field-of-view (FOV) of the glass slide being actively displayed on the main video monitor. Velocity of the stage movements, displayed as lateral movements of the small FOV box, showed the exact relationship of the light microscope’s objective lens to the underlying tissue section. The location of FOV was automatically updated as Dr. Miller, in Washington, D.C., robotically repositioned the glass slide on the microscope’s motorized stage in Texas. Changes in magnification initiated by Dr. Miller, by the press of a button, appeared natural. Focus was easily controlled during scanning of the slide, and readily re-established with each change in magnification. Two-way audio communication was maintained between the laboratory in Texas and the Washington, D.C. COMSTAT boardroom throughout the dynamic telepathology diagnostic session. Technicians and doctors in Texas were in constant communication with Dr. Miller.

 

 

 

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Political debacle with “doc fix” continues…

Now the "doc fix" to address permanently the SGR formula is getting bundled with payroll and unemployment monies, or "programs" as they are sometimes referred to.  Conveniently, Congress can stall the issue further, "kick the can down the road", respond to physician advocates by not repealing the SGR once and for all and continue to add to uncertaintly in the healthcare morass.  But do not fret providers and patients, Congress will take a holiday of their own after the vote Friday paid for by our taxes.

Really good thing the government is not involved with healthcare and a payor system until the Healthcare Law goes into full effect...

The deal on the Medicare "doc fix" received widespread coverage, both in print and online, but mostly in the context of it being part of a larger deal involving extensions of both the payroll tax holiday and unemployment benefits. The AP (2/16, Taylor) reports congressional negotiators worked "into Wednesday night ironing out final details of an agreement to extend a cut in the payroll taxes paid by most Americans. The legislation also would renew jobless benefits for millions more."

The Washington Post (2/16, Kane) says the plan "includes a temporary fix for Medicare's payment plan, which, left unchecked, would lead to a 27 percent drop in fees paid to doctors who treat elderly patients."

In a front-page story, the New York Times (2/15, A1, Steinhauer, Subscription Publication) reports, "A vote on the measure would most likely happen by Friday, when Congress is set to recess for a week."

Deal Would Include $11.6 Billion In Cuts To Healthcare Law. CQ (2/16, Reichard, Subscription Publication) reports, "The tentative agreement House and Senate negotiators reached on Medicare physician payments would block cuts through 2012 and offset part of the cost with $11.6 billion in cuts to the health care law, a GOP aide said Wednesday." The federal health "law cuts would take $5 billion from the $15 billion fund created under the measure to boost programs to prevent chronic diseases, the aide said." Meanwhile, "Medicaid spending for hospitals that treat a disproportionate share of low-income patients would be cut by $4 billion."

The Kaiser Health News (2/16, Carey) "Capsules" blog reports that additionally, "Louisiana would not receive $2.5 billion in additional Medicaid funds included in the health law, according to" the "GOP aide." Lawmakers also "plan to take $9.6 billion from areas that include payment cuts for clinical laboratory services and Medicare 'bad debt,' payments Medicare makes to hospitals and nursing homes when patients cannot pay for their medical care."

Medscape (2/16, Lowes) reports, "Assuming that both the House and the Senate approve the measure, physicians could face another doc-fix drama in the lame-duck Congress that follows the November 6 general election." As of "January 1, 2013, the scheduled Medicare pay cut would top 27.4%, as calculated by the program's sustainable growth rate (SGR) formula." MedPage Today (2/16, Walker) also covers the story.

 CQ (2/16, Reichard, Subscription Publication) reports that "despite concerted efforts by Sen. Jon Kyl, R-Ariz., to apply war savings, it appears that the latest temporary 'doc fix' to block Medicare physician payment cuts under the 'Sustainable Growth Rate' (SGR) physician payment formula without getting rid of the formula itself have come to naught." Some physician groups were critical of the move. In a statement, the American Osteopathic Association said, "It is troubling that Congress continues to operate the nation's largest and most influential health care programs on an ad hoc basis." Meanwhile, American Medical Association President Peter W. Carmel said, "We are deeply disappointed that Congress chose to just do another patch - kicking the can, growing the problem and missing a clear opportunity to protect access to care for patients."

Modern Healthcare (2/16, Zigmond, Subscription Publication) reports that in a statement, Dr. Susan Turney, president and CEO of MGMA-ACMPE, formerly the Medical Group Management Association, said, "We are deeply disappointed that Congress has missed a unique opportunity to repeal the SGR once and for all and instead has chosen political expediency over patients." Dr. Turney also said in the statement, "Group practices are telling us that this congressional decision exacerbates an already unhealthy environment that limits their ability to plan for the future and balance their practice's fiscal health with their desire to continue to serve Medicare beneficiaries."

 

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