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Minority Access to Research Careers (MARC) Program

Posted on January 29, 2012 by ev1

It's time again to consider applying to the Minority Access to Research Careers (MARC) Program. If you are a U.S. citizen or permanent resident, have a 3.0 GPA, will have at least 3 semesters left at University of Arizona after the current spring semester, are interested in pursuing research and aspire a graduate degree in a biomedical field, then you certainly should apply. The benefits and opportunities are MANY and there is no prior research experience required.
The simple application and more information can be found at http://www.cbc.arizona.edu/marc/
The financial benefits are:
paid partial or full tuition
paid health insurance
$1800 per year to travel to science meetings
approximately $900 per month in stipend
The application deadline is Wednesday, February 1st.
If you'd like to discuss the possibilities or have ANY questions, PLEASE feel free to contact me via email (cjneal@email.arizona.edu) or by phone at 621-4667. I'd be very happy to talk with you.
Cindy Neal, Assistant Director
MARC Program
University of Arizona

Source:
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Healthy Heart Conference at The University of Arizona Medical Center:

Posted on January 29, 2012 by ev1

The UA Sarver Heart Center would like to cordially invite you to attend the Healthy Heart Conference at the University of Arizona Medical center on Saturday, February 4th.
The Basics:
Healthy Heart Conference
Saturday, Feb. 4
8am - Noon (Registration, Screenings, Breakfast at 8:00am, Program begins 9:15am)
$15 per person (covers food & materials)
Details: Learn everything you need to know to keep your heart going strong from the experts at The University of Arizona Sarver Heart Center by joining us for the annual Healthy Heart Conference on February 4, 2012! Registration is $15/person and check-in begins at 8AM. Sign in will be located in the main lobby at the University of America Medical Center. Health screenings for blood pressure, diabetes and asthma will also be available in the cafeteria on a first-come, first-served basis until 11 a.m. provided by UA College of Pharmacy students. The program will begin in the DuVal Auditorium at 9:15 a.m.
Speakers: This year speakers include Gordon A. Ewy MD, Lorraine Mackstaller MD, Leslie Ritter PhD/RN, Betsy Dokken NP/PhD, Karl B. Kern MD, Julia Indik MD/PhD, and Robert S. Poston MD. Experts in their fields, they will provide education about how to keep your heart healthy, the important risk factors for heart disease, how to recognize stroke, and controlling diabetes. They will also present findings from research about unblocking arteries, controlling arrhythmias using ablations, and the frontier of robotic surgery.
Dialogue: This panel of Sarver Heart Center experts will also available to answer questions about cardiovascular health, heart disease and current treatment options during extensive Q&A Sessions. Based on successful panel discussions at past Sarver Heart Center events, Dr. Ewy has asked that we build lots of question-and-answer time into each presentation, so truly this conference can be a dialogue between the MDs and PhDs of the UA Sarver Heart Center and the community we serve. Bring your questions!
Outreach: Please consider inviting friends, family and neighbors. This conference is an outstanding opportunity to give them a positive and heart-healthy experience at a half-day event which showcases the best of the Sarver Heart Center. Consider it an early Valentine’s Day gift – even better than chocolate! (And, there will be chocolate!)
How Do I Register? You may register online with a credit card at http://www.heart.arizona.edu. Online registration is secure, quick, and saves you a stamp! Please register by Wednesday, Feb. 1.
Please feel free to let me know if you have any questions. Thanks - we hope to see you on Saturday, February 4th!
Melissa Ludgate
Assistant Health Educator
UA Sarver Heart Center
(520) 626-2419

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Project Sunshine

Posted on January 29, 2012 by ev1

Do you like spending time with children?
Are you looking to volunteer with an organization that supports a great cause?
Would you be interested in helping to bring a smile to a hospitalized child’s face?
If you answered yes to these questions,
PROJECT SUNSHINE would love to have you as a member!
Project Sunshine is a nonprofit, nationwide organization that provides free educational, recreational, and social programs to children facing medical challenges and their families.
The University of Arizona Chapter of Project Sunshine works closely with the
Child Life Specialists at Diamond Children’s Medical Center to bring fun arts and craft activities to hospitalized children, their siblings, and their parents.
Our activities include:
Craft Parties, Book Buddies, Star for a Day, Kids for Kids, Ben’s Bells, Craft Bag Assembling, and Fundraisers!
Come learn more about Project Sunshine at our
New Member Meeting and Orientation:
Monday, January 30th 2012
6:00PM - 7:30 PM
In the Center for Student Involvement and Leadership (CSIL)-
4th Floor of the Student Union Memorial Center
For more information about the Project Sunshine Organization,
please visit the national website at http://projectsunshine.org/
Thank you and we hope to meet you at our meeting!
Project Sunshine Coordinators, 2011-2012
P.S.- If you have any questions about the U of A Chapter of Project Sunshine,
please feel free to email us at uaprojectsunshine@gmail.com

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Undergraduate Research Opportunities Consortium

Posted on January 29, 2012 by ev1

The University of Arizona Graduate College administers five undergraduate research programs. Most are summer-only programs; however, two programs are year-round. All are described below. These programs, along with affiliated Research Experiences for Undergraduates (REUs) are collectively known as the Undergraduate Research Opportunities Consortium (UROC). The UROC programs are designed to prepare underrepresented students for the rigors of graduate school and give them the skills and motivation to apply to top graduate schools & programs. UROC provides participants with excellent research training and graduate school preparation.

Typical eligibility requirements:
Class standing
US citizen or permanent resident
3.0 GPA or above
Strong interest in pursuing graduate education, particularly in earning a master’s or PhD.
Low income or first generation college or underrepresented minority - (requirements vary by program; be sure to check the requirements for each program)
Dates: June 3 - August 8, 2012

Application deadline: most programs have a February 1 deadline (see below for exceptions)

Summer 2012 research opportunities for UA students:
For detailed information visit http://grad.arizona.edu/UROC

Summer Research Institute
SRI, funded by the University of Arizona, is open to juniors and seniors of all disciplines, including social science, humanities and fine arts.
Application Deadline: February 1
Contact: Donna Treloar: dtreloar@grad.arizona.edu
http://grad.arizona.edu/UROC

Minority Health Disparities
MHD, funded by NIH and UA, focuses on health issues that affect minority communities in a disproportionate manner. Open to junior or senior biomedical majors interested in continuing their education at the Ph.D. level.
Application Deadline: February 1
Contact: Stephanie Adamson: adamsons@u.arizona.edu
http://www.grad.arizona.edu/UROC

Biosphere 2 Research Experiences for Undergraduates (NSF REU)
UA’s Biosphere 2 facility is the site of this summer research experience. By using a multidisciplinary approach (involving disciplines such as hydrology, geology, geochemistry, ecology, biology, physics, engineering, and atmospheric sciences) research teams focus on understanding how earth systems respond to environmental change. Open to freshmen, sophomores, and Juniors.
Application Deadline: March 1
Contact: Katerina Donsova, dontsova@email.arizona.edu
http://www.b2science.org/earth/outreach/REU

Hooked on Photonics
HoP, sponsored by the NSF's Center on Materials and Devices for Information Technology Research (CMDITR) of which the UA is a partner institution, is open to undergraduates at any level who are interested in chemistry, physics, material science, engineering or optics. Under-represented students are highly encouraged to apply.
Application Deadline: February 15
Contact: Kimberly Sierra-Cajas kimberly@optics.arizona.edu
http://stc-mditr.org/students/REU/index.cfm

Collaborative Research in the Chemical Sciences
CRCS, an NSF-funded REU program, focuses on collaborative, multidisciplinary research projects that cover a broad range of disciplines within chemistry and biochemistry. Open to freshmen, sophomores, juniors, seniors graduating after program begins.
Application Deadline: February 14
Contact: Dr. Katrina Miranda, kmiranda@email.arizona.edu http://www.cbc.arizona.edu/REU/

Integrated Optics for Undergraduates
UA is the lead institution for this NSF Engineering Research Center. Students work collaboratively with faculty, graduate students, and other professionals on research projects which focus on creating ultra-broadband communication networks using photonics and various other optics applications.
Application Deadline: end of February
Contact: Trin Riojas, trin@optics.arizona.edu
http://www.cian-erc.org/

Year-round research opportunities for UA students:

Ronald E McNair Achievement Program
Funded by the US Department of Education, this program provides low-income, first-generation college, and underrepresented students with opportunities and activities to excel in their undergraduate studies and assistance in admission into doctoral programs.
Application Deadline: February 1
Contact: Andrew Huerta, ahuerta@email.arizona.edu
http://www.grad.arizona.edu/UROC

Minority Access to Research Careers Program
This is a unique research, mentoring, financial, and academic opportunity for UA undergraduates belonging to a group considered underrepresented in biomedical research and who have interest and potential to pursue a career in this broad field. Training and financial support for the last two years of enrollment at UA.
Application Deadline: February 1
Contact: Cindy Neal, cjneal@email.arizona.edu
http://www.grad.arizona.edu/UROC

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India’s first virtual Cancer Pathology diagnostic centre

Posted on January 29, 2012 by ev1

Its is my great pleasure to inform you that Oncopath Diagnostics-India’s first virtual Cancer Pathology centre has started at Pune. !!!!

With the help of India’s first and Only digital pathology slide scanning system at Oncopath diagnostics, pathologists from USA, UK and Canada will be able to provide expert consultation to patients in India !!!!

This centre will be specially helpful for patients and physicians/pathologists in getting second/expert opinion in difficult cases.

Some of the newspaper articles published in local news papers in India ,which highlights Oncopath Diagnostics work in India are mentioned below.

Newspaper articles: click the below links

-Indian express

More info. about Oncopath Diagnostics is available at http://www.OncopathDx.com 

Source:
http://feeds2.feedburner.com/pathtalk

Innovation in Immunohistochemistry (IHC) Staining: Single Piece Flow IHC Slide Processing

Posted on January 29, 2012 by ev1

FREE Special Edition White Paper

Download Your FREE Special Report Today!
Simply Complete the Form Below

Innovation in Immunohistochemistry (IHC) Staining: Single Piece Flow IHC Slide Processing

Innovation in immunohistochemistry (IHC) staining has evolved significantly over the last two decades. The process of staining has shifted from labor-intensive, manual techniques toward semi-automated instruments with off-line processes such as deparaffinization and antigen retrieval, and now to a new generation of baking-through-staining automated instrumentation systems that enable standardization, improved staining consistency, and expedited turnaround times. While automation has positively influenced IHC slide-staining quality and processes, the batch-run method has been a constraint in achieving Lean workflow efficiencies and improved productivity for the anatomic pathology laboratory.

This case study of the Cleveland Clinic Foundation (CCF) IHC work cell analyzes the impact of implementing single piece flow processing approach and comparing single piece flow output to batch processing of IHC slides. Also, this paper examines how third-party workflow consulting enhances the results associated with instrument implementation by also incorporating Lean workflow concepts, such as single piece flow.

The Dark Report is happy to offer our readers a chance to download our recently published FREE White Paper “Innovation in Immunohistochemistry (IHC) Staining: Single Piece Flow IHC Slide Processing” at absolutely no charge. This free download will provide readers with a detailed explanation of how to improve your IHC staining process.

—

Among other topics, this FREE White Paper specifically addresses:

Detailed Case Study data on IHC process.
How incorporating Lean in to the process and optimizing the IHC staining platform can improve TAT.
BenchMark ULTRA platform results.

For more about improving IHC slide processing, please CLICK HERE.

Table of Contents

Executive Summary — Page 3

Preface: Immunohistochemistry (IHC) and IHC Workflow — Page 6

Introduction — Page 9

Chapter 1. Single Piece Flow IHC Platforms — Page 11

Chapter 2. CCF IHC Work Cell — Page 12

Chapter 3. Case Study — Page 14

Chapter 4. Results: Time from Pathologist Ordered IHC Stain to Instrument Verification — Page 17

Chapter 5. Results: Time from LIS Order to Run Completion — Page 19

Chapter 6. Results: Improved Productivity in the IHC Work Cell — Page 21

Conclusion — Page 22

References — Page 23

Appendices

A-1 About the Authors — Page 25

A-2 About Venta Medical Systems, Inc./Roche — Page 26

A-3 About DARK Daily — Page 27

A-4 About The Dark Intelligence Group, Inc., and THE DARK REPORT — Page 28

A-5 About the Executive War College on Laboratory and Pathology Management — Page 29

A-6 About Mark Terry — Page 31

Terms of Use — Page 36

Source:
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Regulators regulating digital scanners

Posted on January 29, 2012 by ev1

In the words of Harry Caray - "Holy Cow!" Karen Titus does an excellent job putting together this piece. Who else could use "Gentlemen, start your turtles", "Alan Greenspan" and also work in "From that perspective, a Class III, or even a Class II, classification, is overkill—like dropping a V8 engine into an Amish buggy" in the same article.

So much blog fodder here I have copied the entire article available for free from CAP Today with my comments below on some of my thoughts on this matter.

Courtesy of CAP Today - Regulators scanning the digital scanners by Karen Titus

A recent panel on whole-slide imaging launched a clear message from the Food and Drug Administration: The agency views WSI systems as Class III medical devices and plans to regulate them as such. Gentlemen, start your turtles.

- The FDA has about 1 million pages that are surprisingly easy to navigate on their website including a "How to Classify Your Device Page". If I am reading this correctly, microscopes are Class I devices, as are colposcopes to diagnose cervical dysplasia and cancer, ditto for stethoscopes, holders for artificial heart valves and some defibrillators are Class 2 (roman numerals should only be used for really important things like Super Bowls). Defibrillators [CITE: 21CFR870.5300] are Class 2! 360 joules of energy that could save your life in a moment or cause death if you do not respond to the TV "CLEAR!". And a slide scanner is Class 3 because? Oh, image quality, right. Apparently the FDA didn't look through the microscope I used today. It was like rice crispies were stuck to the lenses. I am sure the article will provide clear detail on why and how these are Class 3 devices. Let's read on.

While the FDA’s decision was clear, the next steps are anything but. Vendors, pathologists, the FDA, and the Centers for Medicare and Medicaid Services could head in any number of directions next, but they won’t be moving swiftly. In fact, those who were at the meeting are still dissecting the information presented at the panel, as if Alan Greenspan had delivered one of his famously tortured pronouncements from the Federal Reserve.

- Yeah, but unemployment was lower, at a nadir (don't get to use that word often) of 4% in the 1990s. Double digit unemployment, financial collapse, Greece, Spain, housing crisis, fall of Lehman, etc... he only predicted once he started doing stand up to not be forgotten when the oft jovial and always comical Bernake took the chairmanship. Those tortured pronouncements in retrospect weren't as bad as this.

Depending on one’s view, the news will slow efforts to bring WSI for primary diagnosis into U.S. laboratories, with some vendors looking to Europe for regulatory relief; have virtually no impact on large vendors, who, while not necessarily enamored of the FDA’s decision, concede it’s one they can live with; kill the market completely; choke innovation among vendors, especially component makers; possibly put laboratories in jeopardy if they try to validate these systems as laboratory-developed tests under CLIA; or encourage laboratories to use WSI for other, already approved purposes, readying themselves for the inevitable day when whole-slide imaging transforms surgical pathology.

- Sprechen Sie Deutsch? - Come è il tuo italiano?

- I predict no impact, no choking, killing, or jeopardy or pocket translators needed to replace US sales; pathologists are conservative folks with supportive industry innovators and inventors; we will test, test and re-test, then test again and we will transform safely and accurately.

What most agree on is that for the first time, the FDA, which regulates the vendor portion of the vendor-laboratory equation, has “put a stake in the sand regarding digital pathology,” says David Wilbur, MD, professor of pathology, Harvard Medical School, and chair, CAP Technology Assessment Committee.

Note that the stake is in sand. “I suspect there’s going to be a whole lot of give-and-take that comes about in the future,” says Dr. Wilbur, who was in the audience at the panel discussion, held at the annual Digital Pathology Association meeting last fall in San Diego.

In a follow-up interview with CAP TODAY, the FDA’s presenter on the panel, Tremel Faison, noted that her remarks reflect the agency’s current thoughts on digital pathology as it works through the issues, rather than an official announcement. “We anticipate eventually having another public meeting, and/or publishing the guidance,” possibly in the next year, she says.

- I think a formal document would minimize confusion on this matter and time is of the essence, particularly since this issue was first addressed in public forum in October of 2009 and mention of pre-market requirements was stated at that time which are similar in many ways to slides and comments from a few months ago.

Download Faison_DPDevicesPanelMeeting2009

Nonetheless, this was not the usual runic message coming out of a federal bureaucracy. Faison, a former cytotechnologist who is now a regulatory scientist in the FDA’s Office of In Vitro Diagnostics, drew praise from those at the meeting. “There was some clarity from the FDA,” says Walter H. Henricks, MD, who represented the CAP on the panel. Until now, he says, industry and labs have largely been in the dark about how the FDA planned to regulate WSI systems for primary diagnosis. “This was the biggest piece of news coming out of the panel — and it was a big piece of news, even if not entirely unexpected,” says Dr. Henricks, medical director, Center for Pathology Informatics, and staff pathologist, Pathology and Laboratory Medicine Institute, Cleveland Clinic.

- A few editor's notes at this point: Tremel taught me everything I know about cytology as a pathology resident at The National Naval Medical Center (now The Walter Reed National Naval Medical Center) and I know she is doing what she can on this and we will all come out the other end better for doing so. I made some comments in November regarding what the CAP did, should have done and could do to help facilitate what is mentioned below as a several year process. See:

http://www.tissuepathology.com/weblog/2011/11/did-the-cap-do-enough-for-digital-pathology-and-discussions-with-the-fda.html

http://www.tissuepathology.com/weblog/2011/12/what-pathologists-and-the-cap-can-do-to-assist-with-pma-process.html

The Class III label is used for devices the FDA deems as highest risk; to be approved, such devices require general controls (such as quality system regulation and good manufacturing procedures) and premarket approval. A lower level of clearance, Class II, refers to moderate risk devices that already have a predicate device on the market. The lowest-risk device, Class I, requires no pre-market notification.

Dr. Henricks sees no gain in dwelling on the FDA’s reasoning in classifying WSI systems as Class III. “The facts are what were presented,” says Dr. Henricks, who is also a member of the CAP’s Council on Accreditation and of the Diagnostic Intelligence and Health Information Technology Committee.

- In seeking absolute truth we aim at the unattainable and must be content with broken portions.

- One of the first duties of the physician is to educate the masses not to take medicine.

Sir William Osler

A couple of the larger vendors also show an unwillingness to engage in debate; they prefer to keep plugging away, like infantrymen, to bring their systems to market. The Class III announcement barely made them look up. And while it may have opened a door, no one expects to pass through it anytime soon. The last time the FDA participated in a public forum to discuss WSI regulation was 2009, says Dirk Soenksen, president of Aperio. At that time, observers say, the agency appeared to be gathering information. “Now, two years later, we’re finally able to hear some of the learnings they’ve digested. That shows you the pace at which FDA is working,” says Soenksen, who was at the recent DPA panel.

- A snail's pace? Already used "turtle" twice in this post. Besides, he beats the hare so not sure we are good using turtle (OK, 4 times in this post).

Soenksen says the Class III label didn’t surprise him. “But the fact that it surprised some shows you the confusion that exists in the marketplace,” he says.

The confusion exists even at the most basic level, particularly among those who think the FDA’s regulatory hand smacks a little too hard. Faison says she’s routinely asked about the agency’s reach by those who say the microscope isn’t regulated—and since it’s not, they argue, why should devices performing similar functions be tightly regulated? From that perspective, a Class III, or even a Class II, classification, is overkill—like dropping a V8 engine into an Amish buggy.

In fact, Faison explains, microscopes are regulated as Class I devices. That astounds some pathologists, who think, “Nobody regulates my microscope . Why would they regulate my scanner? It’s doing the same thing,” says Anil Parwani, MD, PhD, who spoke at the DPA meeting about the CAP’s recommendations for validating WSI. Digital pathology may be a familiar topic, having been around for a decade or so, but until now regulatory oversight hasn’t been a big part of the conversation.

That’s especially true at trade shows, says Dr. Parwani, where the mushrooming presence of digital devices over the last five years is devoid of anything as mundane as regulatory information. “Not many people know that FDA is even looking at regulating whole-slide imaging,” says Dr. Parwani, division director of pathology informatics, University of Pittsburgh Medical Center.

Those who expected WSI systems to be Class II devices can debate all they want, Soenksen says, but, “That ship has sailed. They’ve made up their mind that this is a Class III, which is why most people are going to Europe with this technology, not the U.S.”

For vendors committed to the U.S. market, the pace to market will be somewhat stately. “You’re talking five years at the earliest when someone’s going to get an approval,” Soenksen says. “People don’t like to face up to that truth, but that’s the timeline.” The FDA will need to clear a vendor to do a clinical study; the vendor will need to do the study; and the FDA will have to approve the PMA.

- Propose 5 pathologists, 5,000 cases, 5 days to achieve "ground truth/panel/consensus disgnosis", then 5 different pathologists each looking at 1,000 cases on both screen and (exempt) microscopes with 5 week washout. Get cheap monitors from BestBuy as to establish minimal technical equipment needed and microscopes with rice krispies dessicating on objectives, typical of many clinical laboratories to replicate "real life". 5 years too long. Eli and Tom will be in the Superbowl again.

Faison declined to comment on when the FDA anticipated receiving vendor submissions.

- After football season is over and before baseball begins. Also known as "February".

Aperio had been talking with the FDA about clinical studies even before the Class III announcement, and it hopes to have an acceptable study design soon. “We’re going to be the first company to get FDA approval,” Soenksen predicts.

Another large vendor, Omnyx, has been in talks with the FDA as well, says Michael Montalto, PhD, one of the company’s founders and vice president of clinical and regulatory affairs. The Class III billing didn’t surprise him, either. “We have a pretty good sense of what we need to do,” says Dr. Montalto, who also attended the panel. “But that’s not as a result of the announcement—it’s because of our continued back and forth with the FDA.”

Dr. Montalto puts a positive spin on the news. “The device will be safe when it comes out. You have to be happy about that.”

- The best interest of the patient is the only interest to be considered

William J. Mayo

Safety, after all, is at the heart of the Class III label. Listing the potential risks of WSI systems, Faison says, “We’re very concerned that the image quality is as good or better than when using the light microscope. Is it like that for all surgical pathology specimens or only for a segment of surgical pathology specimens? What are the differences in human interaction between viewing under the microscope and navigating on the computer screen?”

To answer such questions, the FDA will require clinical studies to validate performance. Here’s where confusion re-enters the room, forcing players to engage in, if not quite brinkmanship, at least a little blinkmanship.

It’s not clear, for example, what types of clinical studies vendors will need to conduct as part of their PMA submissions. Faison gave some general guidelines at the panel, but until the agency receives its first vendor submission, the FDA’s specific desires are likely to be a mystery. “We don’t have all the answers,” Faison says. The more specific vendors can be with their proposed clinical studies, observers say, the easier it will be for the agency to decide whether to grant a green light.

Another unanswered question: How broad or narrow can an intended use be? Will approval be given for diagnosing, say, breast cancer, but not colon cancer? Prostate biopsies but not endometrial biopsies? Or cancer, but not inflammatory skin conditions? “A huge question,” Dr. Henricks says. “I wish I could give you more clarity. I wish I could give me more clarity.”

“This is a tough question,” Faison says. “We don’t want to see a submission for just one organ system—say, breast.” That’s not a realistic intended use, she says, “and we realize that a laboratory would not buy for just that indication.

“On the other hand,” she continues, “performing a study for all of surgical pathology, including frozens, special stains, etc., would be one huge and hardly manageable submission. We are encouraging sponsors to take a hard look at how these devices will most likely be used in the laboratory, employ a ‘fit for purpose’ mentality, and frame their intended use (and therefore clinical studies) around that.” She adds that vendors will need to define the physical and technical characteristics, such as focus, resolution, and color, prior to beginning their clinical studies; in addition, they’ll need to look at what she calls a clinically balanced population.

- Paul Valenstein, MD I think gives the best talk on the issues raised in the last 6 paragraphs. I heard him speak on these issues at a talk several of us gave at USCAP last year.

Download Valenstein_companion06handout

I recall something about needing 65,000 cases but not hemepath, cytology or pigmented lesions

Vendors are dropping few clues themselves. Regarding Aperio’s submission, “It will be as broad as FDA allows it to be,” Soenksen says, punctuating that sentence with laughter.

Vendors are struggling with this issue, Dr. Montalto says, and some are irked that they’ll need to make the first move. But he reminds his industry colleagues that this is a relatively new field. Previous summary statements and clearances aren’t useful guides; every device will have its own nuances, and it’s up to vendors to discuss them with the FDA. “I think they learn a lot from their discussion with vendors. They’re getting educated on this process, too,” he says.

While vendors and the agencies continue their parry, Soenksen sees an opportunity for pathologists to step up. “My personal view is the College needs to lead this,” he says. He suggests that the FDA is looking for cover from the pathology community—if pathologists, and the CAP, made it clear they support WSI and are ready to use it, he says, the FDA would feel more comfortable bringing the systems to market.

The FDA has also irked some pathologists, Dr. Montalto observes, though he speaks diplomatically, gently pointing out that the AP community, in comparison to CP and other clinical specialties, may be less familiar with the demands of bringing new technologies to the marketplace, including the regulatory environment and its requirements for technical validation and understanding the risk profiles of every device.

The FDA will look at the accuracy of the whole-slide imaging approach and the accuracy of the traditional light microscopy approach, comparing both to an adjudicated standard. This reference standard will likely be determined by a panel of three pathologists; agreement by two of the three creates the reference diagnosis. Dr. Wilbur’s preference would have been to consider the glass slide interpretation the de facto gold standard, and then compare digital to that. This approach is more in line with submitting a 510(k) rather than a PMA, showing essential equivalence to a similar, standard technology. “The glass slide is the current gold standard—this type of PMA approach tests not only WSI interpretation, but also the glass slide standard. It will be interesting to see how this sorts out. WSI could turn out to be better with this approach—who knows?” says Dr. Wilbur.

- A growing number of studies have shown superiority of virtual microscopy versus light microscopy (See: http://www.tissuepathology.com/weblog/2011/10/superiority-of-virtual-microscopy-versus-light-microscopy-in-transplantation-pathology.html)

- This could be bad for microscope manufacturers and what about all the diagnoses made on these barbarian, exempt devices?

The FDA’s approach also requires a so-called washout period, during which the pathologist theoretically forgets the initial diagnosis before making a diagnosis on the second technology. “How long do you need to make the study not biased?” Faison asks. “I think randomizing the read order may help with that.”

- I may not remember your name, but I never forget a face. Excuse me, have we met somewhere before? But if you change the read order you already know that the first case is not the first case, or the last the last, unless of course it actually is which sounds like something Dr. House would say but most of us know if you are playing Monopoly and you are the thimble and on Connecticut Avenue and roll a nine then you go to Tennesse Avenue and a subsequent 7 puts you on B&O railroad and 8 more gets you Community Chest. With enough cases (see reference to 65,000 cases above), this might work.

If all this sounds familiar, that’s because it’s similar to the FDA’s approach to regulating automated cytology, says Dr. Wilbur. But it may be more problematic for WSI systems, he says, especially the washout period. “Cytology slides are more difficult to remember, but I would suspect that memory of surgical pathology specimens will be more difficult to wash out,” he says. The FDA’s proposed washout period is a week minimum, Faison says, though she adds that two to three weeks would be optimal. (A CAP workgroup on WSI validation said it has found no widely accepted washout length and has recommended a three-week period.)

- Propose minimum of 2 weeks. Absolute minimum. More than 3 weeks ideal. Increases the chances the slides could be lost, broken, misfiled, destroyed or reused. Usually still in the pathologists office for 2 weeks and cannot be uncovered or identifed as broken or destroyed.

“In addition,” queries Dr. Wilbur, “what about other important aspects of a surgical pathology case?” Compared to cervical cytology, he says, where each case has only one reference diagnosis, surgical pathology specimens may have many aspects to test. In addition to a diagnosis of, say, colon cancer, the pathologist is also expected to grade the cancer, assess the margins, the depth of invasion, and so on. If these parts of the case do not match, how will the FDA handle that? Such patient care issues will make design of the studies potentially complicated, he says.

Beyond this, Dr. Wilbur fears that the FDA’s proposed studies will be too expensive and too difficult for smaller companies to conduct. With the advantage falling to larger companies, it could curb innovation.

He’s particularly concerned about how component makers will fit into the picture. Right now, they don’t. The FDA regards WSI as a system, and that’s the regulatory pathway it’s providing. Dr. Montalto suggests the FDA will eventually take another look at this. But near term, it will likely have a chilling effect on component providers, Soenksen says.

Some fear the decision could be stifling. Pathologists won’t be able to mix and match components as they see fit, and large vendors will have little if any incentive to design flexible systems. “What the FDA presented is the easiest solution,” says Dr. Wilbur, who wants more thought devoted to this issue. How will makers of scanners, image-management systems, or viewing stations break into the primary interpretation market? “They’ll be left out in the cold. This has to be addressed.”

Dr. Wilbur’s concerns point to another mudslide in the making. By recognizing WSI as a system, rather than individual components, the FDA also stated it did not see whole-slide imaging as a laboratory-developed test, which originates in the lab and is put together from initial components. Where does that leave labs that want to validate a non-approved WSI system?

“I’m doing my best to piece this together,” says Dr. Henricks, who adds that the matter has now been tipped into CMS’ lap. “What is CMS going to do about this if they find a laboratory using it? What if the laboratory has done a good validation for its intended use in the lab? What happens?”

- Take home message: We are not actually talking about regulators regulating whole slide scanners (without a predicate device), we are actually talking about regulating whole slide systems. Entire ecosystems - stainers?, scanners, monitors, servers, viewers, pathologists?

It’s not hard to extrapolate further and ask about the implications for CAP inspectors enforcing CLIA. The answers could be scary.

“It’s a panic issue right now,” says Dr. Parwani.

- A perfection of means, and confusion of aims, seems to be our main problem.

Albert Einstein

Attempts to clarify matters further at the panel failed, attendees and panel members say. It wasn’t clear, for example, whether WSI systems that have already received FDA clearance for select use (for example, automated image analysis of breast markers) or for research use only can be validated as LDTs, Dr. Henricks says. FDA regulates manufacturers of medical devices, whereas CMS/ CLIA regulates testing that occurs in clinical laboratories. “I think sometimes it’s a misperception that the FDA directly regulates clinical laboratories, outside of blood bank,” Dr. Henricks says.

Dr. Montalto says that in his conversations with the FDA, the agency appears understandably uncomfortable with the idea of labs employing WSI systems for off-label use. He says the potential for this is a major reason the FDA wants vendors to move quickly on their submissions, so the devices can be proven safe for their intended uses.

- I hope not too quickly here we still need another public meeting and possibly a guidance document possibly in the next year.

Dr. Henricks makes it clear that the CAP accreditation program is not taking a public position on this and will harmonize with the FDA and CLIA and their requirements. “We look to them for some guidance on how to approach this topic,” he says. At the same time, he says, it appears that the CMS would welcome input from the CAP on how to address WSI for clinical purposes.

- I recognize CAP is in a tough spot here and everyone is looking to everyone else for guidance. Please give these folks enough guidance to make the decisions we need them to make. A blocked path also offers guidance. (Last 2 lines with apologies to Mason Cooley and Jimmy Johnson. Who else can use these 2 names in the same sentence, huh?). See if CMS would welcome input from the CAP on additional billing codes for some of these services.

In the meantime, the CAP has already begun addressing WSI via the aforementioned workgroup, which was convened by the College’s Pathology and Laboratory Quality Center. The group (Dr. Parwani and Dr. Henricks are members) put together 13 draft statements for laboratories that want to validate WSI systems. The CAP currently has no accreditation program checklists on WSI validation, but the recommendations might be part of a future such checklist.

- The only question then is who drives this may be, could be, future such checklist, The College’s Pathology and Laboratory Quality Center, CAP’s Council on Accreditation, Diagnostic Intelligence and Health Information Technology Committee or The CAP Technology Assessment Committee. I think a committee should be formed to organize these committees.

The CMS representative on the panel, Debra Sydnor, CT(ASCP), says CLIA is interested in the workgroup’s recommendations. “That is very helpful to us,” she says. But it’s hard to know how that interest will translate into practical action and, ultimately, regulatory compliance.

- One should avoid using the terms "practical" and "regulatory" in the same sentence. Kind of like saying "Notre Dame" and "football" for the past decade and a half. It doesn't sound right. And are we talking about regulations or compliance with said regulations.

Ideally, labs should consider holding off on using WSI for clinical purposes until a system has FDA approval for the appropriate intended use, says Sydnor, cytologist, CMS Division of Laboratory Services. She realizes this is a quixotic notion. Sydnor says she’s been fielding calls from laboratories that intend to use—or are already using—WSI for testing that involves H&E. Most of the questions concern the holder of the CLIA certificate—i.e. where is the final testing done?—rather than validation. For CLIA purposes, the pathology test is the specimen grossing and the microscopic slide interpretation; therefore, the location where they are performed must have the appropriate CLIA certificate and meet the applicable requirements.

- Increasingly grossing/histology services are becoming consolidated and where the tissue is grossed and slide read are different facilities. And a third location could be where the image being used to render the diagnosis is reviewed.

She advises laboratories to look to CLIA regulation 42 CFR 493.1253 for guidance regarding off-label use of the device under CLIA, but notes that additional formal guidance, specific to WSI, will be forthcoming from the agency.

- Until then go to http://edocket.access.gpo.gov/cfr_2010/octqtr/pdf/ 42cfr493.1254.pdf for the aforementioned reference above.

What will happen if a CLIA inspector encounters a laboratory using WSI for clinical purposes? The lab will have to demonstrate appropriate validation, policies and procedures, and other CLIA-related quality assurance practices, as it would for any test, she says, but that’s not the end of the story. “This will involve training and instruction within CLIA,” Sydnor says. “This area of automation is all new to them [CLIA inspectors] as well.”

- What? Level of automation? What level of automation? Validate the slide scanning, disk spinning, pixel transfer? What is being manufactured that will reduce the need for hard physical labor and/or monotonous work. We are actually adding additional steps and work and effort in this process. What humans are being replaced by what instrumentation that would justify the sheer mention of "automation".

She makes clear that CLIA is neither granting permission nor encouraging laboratories to use WSI imaging for clinical purposes right now. At the same time, “CLIA is not out to witch hunt anyone,” she says. “We basically want to know what you’re doing, how you’re ensuring quality testing, and what it is you’d like to do.” Like everyone else at the table, she says, CLIA is seeking data about how well, and how safely, these systems perform.

- Translation: We work for the government and we are here to help. We are not saying that you can't, but we are not saying that you can either.

Meanwhile, what’s a less-adventurous lab to do?

A surprising amount, as it turns out. As Dr. Henricks notes, digital pathology remains viable for uses other than primary diagnosis, including quality assurance, secondary consultations, education and research, and automated image analysis.

Labs should continue using WSI in approved ways, Dr. Parwani says, which will let them move quickly once the systems earn approval for primary diagnostic use. Here the CAP working group guidelines will be valuable, he says, since they’re extensively annotated and draw on available data as well as user experience. Labs can use the guidelines to ensure they have all the components in place and the right workflow as they prepare for the eventual shift to WSI.

- In 5 years we can jump on this right away.

Dr. Wilbur and his colleagues mostly use WSI for continuing education, but in mid-December they inked a contract with an image-management system company, setting them up to do what he calls “intramural” consultation. This will allow pathologists to share cases in the system across multiple desktops, including those at regional affiliates, and enable second opinion consultations to flow into the institution from outside sources.

At UPMC, Dr. Parwani and his colleagues continue to use digital pathology, as they have for the past couple of years, for education, research, QA, and getting opinions from colleagues. They use it for image analysis of breast markers, and they are starting to accept consults from other countries and institutions for second opinions. “We’re trying to use it for all the intended uses that are approved,” he says. They’re participating with a vendor in clinical trials to prepare its system for premarket approval, and their interest in primary diagnostic use looms large. “Most of our pathologists are very comfortable with looking at digital images and looking at digital slides,” he says.

- Who mentioned anything related to pathologists actually being able to read these images and help providers take care of people. When was pathologists abilities to do their jobs to the best of their abilities with the right training, experience and equipment discussed in this process? You mean pathologists can actually do this today? Read images? Like through a microscope? Or a gross photo? Or an electron micrograph?

“There are so many things you can do,” he adds. “This should not stop your march toward digital pathology.” The DPA panel, in his view, was merely one step in the process. He, like Dr. Montalto, even sees it as a positive one. “FDA is looking at it, and we’re going to have a good product in the end.”

- “Everything will be all right in the end. If it’s not all right, then it’s not the end.”

Karen Titus is CAP TODAY contributing editor and co-managing editor.

Of the FDA’s decision to regulate whole-slide imaging systems as Class III devices, Aperio president Dirk Soenksen says, “They’ve made up their mind. . . . You’re talking five years at the earliest when someone’s going to get approval.” How broad will Aperio’s submission be? “As broad as FDA allows,” he says.

Faison

Dr. Henricks

Dr. Montalto

Dr. Wilbur

Dr. Parwani

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

No approval necessary

Posted on January 29, 2012 by ev1

Dr. John M., cardiac electrophysiologist, cyclist, learner and of course physician blogger recently put out 6 reasons why he blogs recently at http://www.drjohnm.org/2012/01/six-reasons-why-doctors-blog/.

Over a year ago, Drs. Mark Pool, Bruce Friedman and I put together an editorial for the Journal of Pathology Informatics entitled "Ten important lessons we have learned as pathology bloggers".

However, John, Mark, Bruce and I failed to mention one important idea/lesson on why physicians blog, or perhaps more specifically on why physicians should blog and a persona motivator for me.

No approval is necessary.

Physicians are some, if not, the most highly regulated and controlled professionals/human beings in our society. Hospitals, practices, insurance companies, state licensing authorities, malpractice insurers, credentialing, JCAHO, FDA, CMS and a host of professional and regulatory organizations, in the case of pathology, CLIA, AABB, CAP, ACS, tumor registries, state reporting agencies, public health agencies, county/state medical societies, all have professional standards, regulations, codes of conduct, standards, good clinical business practices, good housekeeping practices, permits, memberships, inspections, needed credentials (and re-credentials), peer-reviews, etc... (This may be the longest, most gramatically incorrect sentence I have written on this blog in 5 years).

If you do clinical research add to the list, institutional review boards, human use committees, tissue bank committee, adverse reporting requirements, standard reports due, written reports and of course the fruit of your efforts - a manuscript submission, more peer-reviews, committees and re-reviews.

If you write enough, you get invited to speak on what you have written about, expect a program committee, executive committee endorsement and more forms to provide your content to the meeting organizers and disclose any conflicts of interest in your presentation. Attendees of your talk may be required to fill out a questionaire crity appicing your presentation, style and format in order to get their necessary CME certificate to submit to their hospital credentialing, state licensing, group/practice/ employer or malpractice carrier. This in turn affords a physician to keep his/her license, insurance and hospital priveledges only to have to get re-credentialed and obtain more CME.

Of course, this comes with the job. Insuring the safety of the public, maintaining practice standards, high moral character, lifelong learning, contributing to the collective body of knowledge, etc... is part of what being a professional and physician means.

I still do some peer-reviewed writing and help with program committees and agree to speak when offered the opportunity and actually enjoy the process but it can't compare with blogging for the simple fact that no pre-approval is necessary.

No committees, boards, government agencies, regulatory bodies, etc... No spousal, team, company, policy, group, media or IRB approval.

Of course this can create other problems, since there is no safety net and some physician bloggers, in particular, have learned this the hard way. Without objective groups or individuals to review what you write, much like yelling "fire" in a crowded theater is not a useful manner to exercise your right to free speech (particularly if there isn't a fire) one needs to keep in mind effective blogging for the masses. To educate, archive, connect, show humaness, display interesting information within your niche and give perspective.

Not sure how to end this but fortunately I have an article review due in a few hours, IT committee meeting to prepare for, credentials packet due, a manuscript that is overdue and disclosure forms to submit for an upcoming meeting so my approval-free time is up...

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

Free Webinar from 3DHISTECH – February 22 – Register Now!

Posted on January 29, 2012 by ev1

"Automated High Throughput Whole Slide Imaging Using Area Sensors, Flash Light Illumination and Solid State Light Engine"
presented by Varga Viktor Sebestyén, PhD from 3DHISTECH Ltd.

Program of the webinar:

1. Camera technologies:
- a.) Line versus Area camera
- b.) CCD versus sCMOS sensors
- c.) Scanning speed
2. Multifocal capability
3. Dark Field Preview.

Date: 22th of February, 2012

Please choose one of the following sessions:

Session 1 starting at 9.00 CET(13:30IST, 16:00 SGT, 17:00 JST) session
Session 2 starting at 17:00 CET(11:00 EST, 10:00 CST, 8:00 PST) session

If you choose the first session please follow the instructions described in this mail.
If you prefer the second session please follow the instructions in our next e-mail!

Topic: Automated High Throughput Whole Slide Imaging Using Area Sensors, Flash Light Illumination and Solid State Light Engine
Host: 3DHISTECH Webinar
Date and Time:
Wednesday, February 22, 2012 9:00 am, Europe Time (Amsterdam, GMT+01:00)
Wednesday, February 22, 2012 12:00 pm, Russian Time (Moscow, GMT+04:00)
Wednesday, February 22, 2012 1:30 pm, India Time (Mumbai, GMT+05:30)
Wednesday, February 22, 2012 4:00 pm, Singapore Time (Singapore, GMT+08:00)
Tuesday, February 21, 2012 8:00 pm, Dateline Time (Marshall Islands, GMT-12:00)

This event requires registration.
-------------------------------------------------------
To register for the online event
-------------------------------------------------------
1. Go to https://3dhistech-events.webex.com/3dhistech-events/onstage/g.php?d=701546360&t=a&EA=keithjkaplanmd%40gmail.com&ET=2be271ecefbbc5fd5e49bdbb1e7840da&ETR=441b49bef4a134908fbc6ba03b0a445b&RT=MiMw&p
2. Click "Register".
3. On the registration form, enter your information and then click "Submit".

Once the host approves your registration, you will receive a confirmation email message with instructions on how to join the event.

-------------------------------------------------------
For assistance
-------------------------------------------------------
You can contact 3DHISTECH Webinar at:
mariann.trnik@3dhistech.com

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

Longevity, heroism saluted

Posted on January 29, 2012 by ev1

The nation’s oldest Medal of Honor recipient, a World War II
Army veteran who fought in the Battle of the Bulge, will
celebrate his 95th birthday at a party today at a Clifton VFW Post.

ELIZABETH LARA/STAFF PHOTOGRAPHER

Army veteran Nicholas Oresko, 95, received the Medal of
Honor for his bravery during the Battle of the Bulge in
World War II in 1945. His birthday, and his
accomplishments, will be honored today in Clifton.

Nicholas Oresko of Cresskill, a U.S.
Army master sergeant and Purple Heart recipient who
single-handedly wiped out two enemy bunkers near Tettington,
Germany, on Jan. 23, 1945, will also commemorate the 67th
anniversary of his heroism at today’s party at VFW Post 7165 on
Valley Road.

Oresko’s birthday was Jan. 18, and each invitee has been asked
to bring a younger person to hear the story of the hero platoon
leader with Company C, 302nd Infantry, 94th Infantry Division.

Back in January 1945, when the 28-year-old Oresko and his unit
were taking on heavy fire from the Germans, the situation
looked grim.

"We attacked their positions several times, and we got beaten
back," he said. "It’s terrible. It scares the hell out of you.

"So we figured this time, let’s sneak up on them," Oresko said.
"Instead of getting prepared with artillery fire, let’s just go
as it gets dark and sneak up on them and then attack ’em."

Oresko started out solo — at 4:30 a.m. that cold winter
morning. He assessed his chances.

"I looked up to heaven and said, ‘Lord, I know I’m going to
die, please make it fast,’ " he said.

Oresko realized that a machine gun in a nearby bunker must be
eliminated, and he did so alone, according to the 1945 citation
honoring his brave actions. Facing heavy gunfire, he tossed a
grenade into the bunker, then rushed it with his M-1 rifle and
killed any hostile forces who survived the explosion.

Another machine gun opened fire and knocked him down, seriously
wounding Oresko in the hip, the citation says.

Oresko said he managed a slow crawl to another bunker.

"The machine gunner who shot me thought I was dead," Oresko
said. "I was able to move around, sneak around, so they didn’t
see me. They saw me go down. They thought they’d killed me, but
they didn’t. I slipped around and somehow got around, and they
were in a bunch."

Oresko crawled back for grenades he’d dropped from inside his
jacket and advanced to an enemy dug-in machine gun. He crippled
the gun with a grenade blast and wiped out the troops manning
it with his rifle, the citation says.

"I got to the position to do what I was supposed to do, and I
couldn’t because I had no grenades," Oresko said. "I had to
crawl back a couple of feet and pick up the grenades. I was
almost afraid to do that, but I figured, what the hell?"

See the rest here:
Longevity, heroism saluted

Research and Markets: Brazil In Vitro Diagnostics Market Outlook to 2017 – Clinical Chemistry Genetic Testing …

Posted on January 29, 2012 by ev1

DUBLIN--(BUSINESS WIRE)-- Research and
Markets(http://www.researchandmarkets.com/research/db2156/brazil_in_vitro_di)
has announced the addition of GlobalData's new report
"Brazil
In Vitro Diagnostics Market Outlook to 2017 - Clinical
Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and
Microbiology Culture" to their offering.

GlobalData's new report provides key market data on the
Brazil In Vitro Diagnostics market. The report provides value
(USD million) data for each segment and sub-segment within
seven market categories - Clinical Chemistry, Genetic
Testing, Haematology, Histology And Cytology, Immuno
Chemistry, Infectious Immunology and Microbiology Culture.
The report also provides company shares and distribution
shares data for each of the aforementioned market categories.

Scope

Market size and company share data for In Vitro
Diagnostics market categories - Clinical Chemistry, Genetic
Testing, Haematology, Histology And Cytology, Immuno
Chemistry, Infectious Immunology and Microbiology Culture.

Annualized market revenues (USD million) data for each of
the segments and sub-segments within seven market categories.
Data from 2003 to 2010, forecast forward for 7 years to 2017.

2010 company shares and distribution shares data for each
of the seven market categories.

Global corporate-level profiles of key companies
operating within the Brazil In Vitro Diagnostics market.

Reasons to buy

Develop business strategies by identifying the key market
categories and segments poised for strong growth.

Develop market-entry and market expansion strategies.

Design competition strategies by identifying
who-stands-where in the Brazil In Vitro Diagnostics
competitive landscape.

Develop capital investment strategies by identifying the
key market segments expected to register strong growth in the
near future.

Companies Mentioned:

F. Hoffmann-La Roche Ltd.

Siemens Healthcare

Abbott Laboratories

bioMerieux S.A.

Bio-Rad Laboratories, Inc.

HORIBA, Ltd.

Becton, Dickinson and Company

Sysmex Corporation

Ortho-Clinical Diagnostics Inc.

DiaSorin S.p.A

Beckman Coulter, Inc.

Alere Inc.

Phadia AB

Qiagen N.V.

Thermo Fisher Scientific Inc.

Gen-Probe Incorporated

PerkinElmer, Inc.

For more information visit
http://www.researchandmarkets.com/research/db2156/brazil_in_vitro_di

Read the rest here:
Research and Markets: Brazil In Vitro Diagnostics Market Outlook to 2017 - Clinical Chemistry Genetic Testing ...

Research and Markets: Canada In Vitro Diagnostics Market Outlook to 2017 – Clinical Chemistry Genetic Testing …

Posted on January 29, 2012 by ev1

DUBLIN--(BUSINESS WIRE)-- Research and
Markets(http://www.researchandmarkets.com/research/4f267f/canada_in_vitro_di)
has announced the addition of GlobalData 's new report
"Canada
In Vitro Diagnostics Market Outlook to 2017 - Clinical
Chemistry Genetic Testing, Haematology, Histology And
Cytology, Immuno Chemistry, Infectious Immunology and
Microbiology Culture" to their offering.

GlobalData's new report,
Canada In Vitro Diagnostics Market Outlook to 2017 - Clinical
Chemistry Genetic Testing, Haematology, Histology And
Cytology, Immuno Chemistry, Infectious Immunology and
Microbiology Culture provides key market data on the
Canada In Vitro Diagnostics market. The report provides value
(USD million) data for each segment and sub-segment within
seven market categories - Clinical Chemistry, Genetic
Testing, Haematology, Histology And Cytology, Immuno
Chemistry, Infectious Immunology and Microbiology Culture.
The report also provides company shares and distribution
shares data for each of the aforementioned market categories.
The report is supplemented with global corporate-level
profiles of the key market participants with information on
company financials and pipeline products, wherever available.

Scope

Annualized market revenues (USD million) data for each of
the segments and sub-segments within seven market categories.
Data from 2003 to 2010, forecast forward for 7 years to 2017.

2010 company shares and distribution shares data for each
of the seven market categories.

Global corporate-level profiles of key companies
operating within the Canada In Vitro Diagnosticsmarket.

Companies Mentioned:

Siemens Healthcare

Abbott Laboratories

F. Hoffmann-La Roche Ltd.

Beckman Coulter, Inc.

Ortho-Clinical Diagnostics Inc.

bioMerieux S.A.

Becton, Dickinson and Company

Bio-Rad Laboratories, Inc.

Biomedica Diagnostics Inc.

Sysmex Corporation

Qiagen N.V.

Immucor, Inc.

Alere Inc.

Gen-Probe Incorporated

DiaSorin S.p.A

Thermo Fisher Scientific Inc.

Phadia AB

Hologic, Inc.

Grifols, S.A.

Life Technologies Corporation

HORIBA, Ltd.

PerkinElmer, Inc.

For more information visit
http://www.researchandmarkets.com/research/4f267f/canada_in_vitro_di

Vet-Stem Announces Milestone of 8,000 Animals Treated With Vet-Stem Cell Therapy

Posted on January 28, 2012 by ev1

POWAY, CA--(Marketwire -01/27/12)- Vet-Stem, Inc. today
announced that over 8,000 animals have now been treated with
Vet-Stem cell
therapy.

Vet-Stem
began providing stem cells to veterinarians in 2004
and has now provided stem cells for the treatment of over
8,000 animals. Vet-Stem was the first company to introduce
rapid turnaround stem cell services in the US. After
providing stem cells for thousands of horses, Vet-Stem
pioneered stem
cell therapy in dogs and cats and is now the world
leader in Regenerative Veterinary Medicine™. The rapid
adoption of stem cell therapy by equine veterinarians and
horse owners provided a springboard for use in small animal
veterinary medicine.

Greater than 75% of horses treated with Vet-Stem cell therapy
for tendon and ligament injuries are able to return to their
previous level of performance. Dog owners report that greater
than 80% of dogs treated with Vet-Stem cell therapy have an
improved quality of life.

"We are proud that so many dog, horse, and cat owners as well
as veterinarians have placed their trust in Vet-Stem cell
therapy. We feel a great sense of accomplishment knowing that
there are now over 8,000 horse and pet owners who have
experienced the benefit of stem cell technology. This
practical and beneficial application of technology puts stem
cell therapy into the present day instead of a future
theoretical concept," said Bob Harman, DVM, MPVM, Founder and
CEO of Vet-Stem.

Vet-Stem is now working with small animal veterinarians to
develop other life-saving uses for stem cell therapy for
injuries and diseases that currently have few treatment
options.

More information about Vet-Stem can be found at http://www.Vet-Stem.com ^[1]

About Vet-Stem, Inc.:
Vet-Stem, Inc. was formed in
2002 to bring regenerative medicine to the veterinary
profession. This privately held company delivers stem cell
and related services and products to veterinarians to treat
diseases in dogs, cats and horses. These technologies utilize
the natural healing properties inherent in all animals to
reduce pain and improve the quality of life of our animal
companions. Published studies have confirmed that
adipose-derived stem cells can dramatically improve the
healing of injuries and diseases that have had very few
treatment options in the past.

Vet-Stem holds the exclusive worldwide veterinary rights to
the Artecel (University of Pittsburgh) and University of
California adipose stem cell patent portfolio of over 55
issued patents.

References

^{^} http://www.Vet-Stem.com
(us.lrd.yahoo.com)

Go here to see the original:
Vet-Stem Announces Milestone of 8,000 Animals Treated With Vet-Stem Cell Therapy

Molecular pathology boon for prenatal diagnosis: Expert

Posted on January 28, 2012 by ev1

References

^{^} Return to homepage
(www.calcuttanews.net)

Home ^[1]

Calcutta News.Net
Saturday 28th January, 2012 (IANS)

Around half a million newborns in India suffer from
congenital genetic disorders every year - the highest in
the world - but advances like molecular pathology have
helped detecting these disorders at early stages, an
expert said Saturday.

"The number of children born with genetic disorders in
India is highest in the world," I.C. Verma, director, Sir
Ganga Ram hospital, said at International Symposium on
Molecular Pathology here.

However, because of advancements like molecular
pathology, the cases of genetic disorders are being
detected at an early stage, he said.

"There has been an increase in prenatal diagnosis in such
cases and its success is above 30 percent," Verma
claimed.

Molecular pathology is a discipline within pathology
which focuses on the study and diagnosis of disease
through the examination of molecules within organs,
tissues or bodily fluids.

See more here:
Molecular pathology boon for prenatal diagnosis: Expert

Industrial Microbiology PowerPoint – Video

Posted on January 28, 2012 by ev1

27-04-2010 16:09 A slideshow explaining the basics behind genetic engineering as it relates to microorganisms; the technology of recombinant DNA; the use of mRNA, cDNA, expression vectors and plasmids; and applications of genetically modified bacteria, such as with insulin production, oil spill cleanup, and crops.

Visit link:
Industrial Microbiology PowerPoint - Video

LONGEVITY StickWeld 140 110/220v Dual Voltage 140AMP DC Stick Arc Welder IGBT – Video

Posted on January 28, 2012 by ev1

19-02-2011 17:10 LONGEVITY Welding offers plasma cutters and TIG / MIG / ARC / STICK Welders and MultiProcess welding equipment at affordable prices with the industry's best 5 year parts and labor warranty. Check out the latest welders and cutters at http://www.longevity-inc.com. This contest featured our LONGEVITY WeldAll 200PI on http://www.freeweldingforum.com - your place for welding advice and tips. If you want to learn how to weld, join http://www.freeweldingforum.com and ask some of the professional welders on our site. Here we are introducing the LONGEVITY StickWeld 140 which is a 140amp DC stick welder that is dual voltage. This model is extremely portable and affordable. It features a carrying case and is versatile as it will take 110v or 220v hookup Link to Product: http://www.longevity-inc.com

Swampscott School Committee agrees to correct longevity pay

Posted on January 28, 2012 by ev1

For much of the past decade, many Swampscott teachers were paid
an incorrect amount, because a clause in their contract
concerning longevity was misunderstood.

While the problem has been corrected, some teachers over that
time period were overpaid, while others were underpaid,
according to School Department Business Manager Ed Cronin at
the School Committee’s meeting on Wednesday, Jan. 18.

“The results basically show that going back to 2003, teachers
were incorrectly paid longevity,” Cronin said. “What we’d
like to do is rectify that problem.”

Cronin said he had been meeting with leaders of the teachers’
union starting last fall to determine “exactly what [the
longevity clause] was meant to say and what the impact was and
broke down the results.”

The overall results showed a total of about $40,000 went to the
overpaid teachers, while the teachers who were underpaid were
owed about $30,000.

“We’ve put in place something that will fix the problem going
forward,” said Cronin. “So it will no longer exist. But we
still have past inequities to deal with.”

The School Committee agreed to Cronin’s recommendation that the
School Department pay the $30,000 owed to those teachers who
were underpaid and forget about the money that was overpaid to
the other group of teachers.

The motion was approved on a 4-0 vote, after committee member
Marianne Hartmann recused herself. Hartmann is a school nurse.

“I think it’s important for the public to understand, this is
not something that we are giving away,” said committee member
Rick Kraft. “We really made a very serious evaluation of this
in terms of what the impact would be if we to tried to collect
that money [that was overpaid]. And doing that would have had
such a negative impact on the teaching environment and the
school environment that really the best thing to do is just
move on from here.”

Cronin explained that the amount of money involved was much
less than 1 percent of the school’s $26 million budget.

“The work that was done with the union here is fabulous and I
would like to keep that feeling alive,” Cronin said. “We are
talking small money, especially given the cost involved in
trying to collect backpay that goes back to 2003 and that would
eat into any money that we would collect anyway.”

“The committee is very, very committed to the building of the
trust and the building of collaboration [with the teachers],”
Superintendent Lynne Celli said. “I would like to personally
thank the committee for taking this position, and it’s most
appreciated.”

A dozen or so teachers attended the meeting, including
Swampscott Education Association official Jon Flanagan, who
thanked the committee after their vote.

Link:
Swampscott School Committee agrees to correct longevity pay

Lars Anderson: Biggest offseason winner; Gordon's longevity; power teams; more mail

Posted on January 28, 2012 by ev1

Rick Hendrick spared no expense in building a new fleet of
Chevys for his team this offseason.

Mike McCarn/AP

The message was the same from every race team during the Sprint
Cup media tour: The guys in the shop have been working
really, really hard. Our cars will be faster. Our engines will
be stronger. We honestly believe we'll win the championship
this year.

January is the month of promise in NASCAR. We're still four
weeks away from the Daytona 500, and everyone in the sport --
even the small-money teams -- genuinely believes that 2012 will
be a special year. But after talking to dozens in the sport
over the last few days during the tour, I believe one team is
better positioned to dominate the season than any other:
Hendrick Motorsports.

Owner Rick Hendrick has never been one to bite into the apple
of hyperbole, so when he said that he likes the chances of all
four of his drivers -- Jimmie Johnson, Jeff Gordon, Dale
Earnhardt Jr. and Kasey Kahne -- qualifying for the Chase and
one winning the championship, it's worth taking notice.
Hendrick has as many resources as any other team in NASCAR, and
this offseason the owner spared no expense in building a new
fleet of Chevys.

In our NASCAR preview issue [on newsstands now] we at SI
made Jimmie Johnson, the five-time champion, our pick to hoist
the big trophy at Homestead-Miami Speedway in November. But he
surely won't be the only Hendrick driver to thrive in 2012,
which leads us to our first question ...

Do you think [Jeff] Gordon will seriously contend for a
Chase title again -- in other words was last year a fluke as he
[apparently] transitions to elder
statesman/ambassador/full-time businessman?

-- George, Columbia, S.C.

I do think Gordon has as many as five championship-contending
years left in NASCAR. Last season the 40-year-old Gordon had 13
top-five finishes -- the same as in 2002, when he was
supposedly in the prime of his career -- and he led 922 laps,
which was his most since 2007. Even though Gordon has been
involved in several horrifying crashes in the last few years,
he doesn't appear gun shy and it doesn't seem like he's lost
any of his hand-eye-foot coordination.

Given that Gordon will again be piloting superior equipment in
2012 and he'll again be teamed with crew chief Alan Gustafson
(who in my opinion is the most underrated pit boss in NASCAR),
I think Gordon will cruise into the Chase. The playoff doesn't
set up well for him, as his best tracks aren't in the Chase,
but if he gets a little racing luck, who knows? He certainly
still has the driving skill to win a fifth title. The numbers
back that up.

Lars, quick question ... in your note about EFI, you
hypothesize that the change should help the big-money teams,
and you list Hendrick, Roush and Gibbs. The premise makes
perfect sense ... but my question is, does Roush still belong
in that list? They lost sponsorship on one car, and while they
did pick up Best Buy, they are running the No. 17 without
anything near full funding. The Carl Edwards package is
probably as big as anyone's in the sport, but does Roush still
qualify as a "big-money" team? Do we need to re-evaluate what
we consider the power teams?

-- Brian, Brookline, Mass.

Great question. For now I do think Roush belongs on that list,
especially considering that Edwards lost the championship last
year by a grand total of one point.

I think the future is actually pretty bright for RFR. Edwards
looks like he'll be a force in the sport for years to come.
Matt Kenseth has finished eighth or better in the final
standings in eight of the last 10 years. Greg Biffle struggled
last season but has shown that he's capable of contending for
titles (he finished second in points in 2005 and third in '08).
And Ricky Stenhouse Jr., the reigning Nationwide champion,
likely will jump to the Cup series full-time with Roush in
2013, when I think RFR will again field four cars.

Yes, RFR has had some sponsorship problems, but I don't think
the team is to the point yet where they'll be at a competitive
disadvantage because of a lack of resources.

What do you think will be the remaining race that Danica
Patrick will race in the NASCAR Sprint Cup Series in 2012?

-- Chris Fiegler, Latham, N.Y.

Right now Patrick is scheduled to run in 10 Cup events. She'll
be in the Daytona 500 and said last week she'll compete in the
Coke 600 at Charlotte Motor Speedway on Memorial Day weekend
rather than in the Indy 500. Nine of her 10 races are set.

If I were her team owner Tony Stewart, I'd start Patrick in the
season-finale at Homestead-Miami Speedway, a 1.5-mile oval.
Intermediate-length tracks form the core of the Chase schedule
(five of the 10 races in the playoffs are on 1.5-milers) and so
if Patrick is ever going to contend for a title (and I know,
we're years away from THAT), she'll need to perform well
on these venues. Plus, if Stewart is in the hunt for another
title, it wouldn't hurt to have an extra teammate on the track.

Referring to carburetors as "outdated" technology, can you
explain if EFI will increase Sprint Cup engine power output?
Will the brake-specific fuel consumption be improved? Will the
fuel economy improve? My guess is EFI will offer very marginal
improvements, but a big boost in racing cost. Carburetors are
that good, even if they are "outdated."

-- Roger Lake, Los Angeles, Calif.

You're right -- sort of. EFI definitely has spiked racing
costs, but the early testing has revealed that it has increased
fuel economy. As for engine power output, several drivers told
me that the cars don't have as much initial acceleration, but
that gains in overall horsepower have been made.

EFI will be one of the biggest stories of the 2012 season.
Whichever team can harness the potential of EFI the quickest
will have the inside track on the championship.

See original here:
Lars Anderson: Biggest offseason winner; Gordon's longevity; power teams; more mail

Cortland supports governor's proposal to expand DNA databank

Posted on January 28, 2012 by ev1

This section displays the last 50 news articles that were
published.

Updated 01/27/2012
06:26 PM

The latest support for a proposal to expand New York's DNA
databank is coming from Cortland. The mayor and police chief,
joined by state officials Friday, explained how DNA evidence
recently helped solve a burglary and stabbing in the city. Kat
De Maria has more.

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CORTLAND, N.Y. -- After thousands of dollars in jewelry went
missing from Sheridan's Jewelry on Main Street in Cortland,
there wasn't much evidence, except blood from a broken window.
The sample went into the national DNA index system and returned
a match: Kristopher Thierl.

Cortland's police chief says officers found Thierl already in
the county jail on robbery charges. But he was caught because
of the DNA taken in the course of other felony charges in
Washington State. Thierl pleaded guilty to the burglary and
robbery and remains in prison.

Under Governor Andrew Cuomo's proposal to expand New York's DNA
Databank, Cortland police wouldn't have had to rely on outside
authorities to convict him.

"That would include everything from ag and market felonies to
motor vehicle felonies, as well as all of the penal law
misdemeanors, which is going to bring a number of new samples
into the databank that we wouldn't have had before to compare
against all unsolved crimes," said Tina Stanford, director of
the New York State Office of Victims Services.

Another case in Cortland saw a suspect deported back to his
home in the West Indies following a stabbing on Groton Avenue.
A hat had been left at the scene. And following the incident,
police say the suspect became part of a rape investigation and
gave DNA.

"They were cases that would not have gone anywhere had it not
been for the DNA match to evidence collected at the scene,"
said Cortland Police Chief Michael Catalano.

At a press conference Friday, advocates explained that
currently in New York, DNA is required from less than half of
people committing crimes and then only the most serious ones.
But they say they'd rather not wait for criminals to get that
far.

"We know that many felons and violent felons will commit minor
crimes either before or after a violent crime. It's not as
simple as going out and committing a heinous crime," Catalano
said.

Advocates say since the DNA Databank was established 16 years
ago, the evidence has helped solve more than 2,700 crimes,
including six in Cortland.

"It is going to be a useful tool for police, not just in
Cortland, but throughout the state," said Cortland Mayor Brian
Tobin.

Advocates say the DNA databank codes its profiles by number,
which do not include a name or any other identifying
information. Only in the event of a match is the name revealed,
through a separate state agency.

References

^{^} How to enable JavaScript
(www.google.com)
^{^} Install Adobe Flash player
(www.adobe.com)

Follow this link:
Cortland supports governor's proposal to expand DNA databank

DNA evidence, defendant's testimony clash in trial for accused shooter in Corey Nash homicide

Posted on January 28, 2012 by ev1

SAGINAW — DNA evidence appears to contradict today’s testimony
from the accused shooter in the August 2010 death of Corey
Nash.

State Police Forensic Scientist Heather Clark testified today
that Travis D. Farrow’s DNA was found on a .40-caliber Glock
handgun that police said was thrown from the vehicle that
Bryant E. Bentley Jr. and Farrow were riding in after Nash’s
shooting death.

Clark testified during the fourth day of Farrow’s trial before
Saginaw County Circuit Judge James T. Borchard. The trial was
to continue Tuesday.

Nash was shot about 4:45 p.m. Aug. 1 in the parking lot of the
Riverview Plaza strip mall on West Genesee between North
Michigan and North Niagara on Saginaw’s West Side.

Farrow ^[1] took
the stand in his own defense this afternoon and delivered a
version of the events much like his second statement to
police ^[2]. He
testified that Bentley arranged a cocaine deal with Nash and
then shot Nash in the parking lot after an argument while
Farrow was in Bentley’s white Chevrolet Lumina van. Farrow
testified that Bentley came back to the van with two guns and
cocaine, they drove away and soon were chased by police.

Testimony earlier this week showed that two guns — the
.40-caliber gun and a .45-caliber Colt handgun — were thrown
from the passenger side of the vehicle. Farrow on Friday
admitted to throwing the guns from the van.

State police Detective Sgt. Ryan Larrison testified that the
Glock handgun fired two shell casings located in the Riverview
parking lot. The firearms expert testified that he could not
exclude the Glock from being the gun that fired the bullet that
killed Nash. Clark testified that Bentley’s DNA was not on the
.40-caliber gun.

Farrow also told police that he was wearing a red shirt, not a
black shirt, when the shooting happened and he and Bentley ran.
Clark testified that Farrow’s DNA was not on the red shirt
seized in connection with the chase and identified as the shirt
that the driver of the van was wearing. Farrow testified Friday
that he was wearing the black shirt and that his words were
mixed up by police during the interview.

Additionally, Clark testified that Nash’s DNA was found on the
van’s steering wheel and interior driver’s side door handle.
Such evidence contradicts Farrow’s statements and agrees with
the story that a fellow jail of inmate of Farrow’s testified
Friday that he heard Farrow tell another inmate.

In that story, Nash entered the van, argued with Bentley, threw
the cocaine out of a window, and began fighting with Bentley
for a gun. Farrow stepped out of the van, grabbed the cocaine,
and then, at Bentley’s request, shot Nash, the inmate
testified. The inmate who said he heard the confession denied
Friday that he heard Farrow confess.

After a four-month investigation, prosecutors charged Farrow,
who last lived at 613 N. Mason in Saginaw, and Bentley with
felony murder, which means that someone was killed during the
commission of a specified felony, armed robbery, and conspiring
to commit that crime. Farrow faces six other felonies.

A jury in October acquitted Bentley of the murder charge and
convicted him of armed robbery, conspiracy and nine other
felonies. Borchard sentenced
Bentley ^[3] to a total
of 64 years and six months to 95 years and nine months in
prison.

References

^{^} Farrow
(topics.mlive.com)
^{^} second statement to police
(www.mlive.com)
^{^} sentenced Bentley
(www.mlive.com)

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