The Daily Scan

FDA Approves Genetic Test for Patients With Breast Cancer

From MedScape: FDA Approves Genetic Test for Patients With Breast Cancer.

The US Food and Drug Administration (FDA) has approved the genetics-based SPOT-Light test (Invitrogen Corp) to help predict response to trastuzumab (Herceptin, Genentech) therapy in patients with breast cancer when used in conjunction with other clinical information and laboratory test results.

"This test is used to determine which patients will receive herceptin therapy," Steven Gutman, MD, FDA director, Office of In Vitro Diagnostics, told Medscape Pathology & Lab Medicine. "As is true with all tests, there can be false-positive or -negative results."

The new HER2 chromogenic in situ hybridization (CISH) test measures the number of copies of the HER2 gene, which regulates the growth, division, and repair of cancer cells, in tumor tissue. Although normal breast cells have 2 copies of the HER2 gene, breast cancer cells may have more copies of the HER2 gene. Overexpression of HER2 protein results in greater stimulation of breast cancer cells, causing them to replicate more quickly.

Using an appropriately stained biopsy specimen, the new test allows visualization with a standard light microscope of a color change that identifies HER2 genes, thereby eliminating the need for fluorescent microscopy. Another advantage of the test when compared with existing assays is its ability to store the tissue for future analysis.

Interesting, a brightfield test for Her2 which is not IHC.  I wonder if any studies have been done head-to-head to show whether this test is more accurate?

HDC, DCL Medical to create new imaging tests for digital pathology

From HealthImagingNews: HDC, DCL Medical to create new imaging tests for digital pathology.

Health Discovery Corporation (HDC) and DCL Medical Laboratories have signed an agreement for the collaborative development and commercialization of support vector machine (SVM)-based computer-aided detection (CAD) tests for the independent detection of ovarian, cervical and endometrial cancers.

Tests will be performed on digital images to assist pathologists in providing more accurate diagnoses on biopsy and surgical specimens, according to both companies.

...

Through the advancing technology of pattern recognition, both companies said that the new SVM-based diagnostic imaging systems are expected to improve the sensitivity of detection for endometrial and cervical cancers and significantly improve the specificity of ovarian cancer diagnosis. In addition, images and interpretative data from the new SVM-based systems will be designed for use in web-based applications, thus allowing remote review, second opinions and collaborative pathologist interpretation.

I assume the tests will use photomicrographs rather than whole-slide images, although the article doesn't say.  It is interesting to see more companies developing software tests in digital pathology.  The industry is evolving rapidly, both on the technical and business fronts...

MedPedia Is Wikifying the Medical Search Space

TechCrunch reports that MedPedia Is Wikifying the Medical Search Space.

MedPedia is a new project, currently in development, that will offer an online collaborative medical encyclopedia for use by the general public.  In order to keep the content accurate and up-to-date, content editors and creators have to have an MD or a PhD.  Several highly-esteemed medical colleges will be contributing content to MedPedia, including Harvard Medical School, Stanford School of Medicine, UC Berkeley School of Public Health, and University of Michigan Medical School.  Medpedia is also receiving support from the National Institutes of Health (NIH), the Centers for Disease Control (CDC), the Federal Drug Administration (FDA) and many other government research groups.  The content from these organizations will then be edited by MedPedia’s community of medical professionals.

Wow, cool.  This sounds like it will turn into an excellent resource.  The best part is, it will only get better over time, as more and more people use it and improve it.

FDA funding future brightens

The Scientist writes FDA funding future brightens:

The Senate Appropriations Committee approved a whopping budget of more than two billion dollars for the FDA in 2009.  On Thursday (July 17), the committee unanimously passed the markup, which would represent an increase of more than $324 million over the FDA's 2008 budget and the first time the agency's budget would breech the two billion dollar mark.

The FDA budget boost is part of a larger bill, totaling almost $20.5 billion, that also contains provisions for global food assistance, rental assistance for some low-income households, and rural development.

This has to be considered a good thing; for those of us who work with the FDA, we can't help but be impressed by the diligence of their examiners, and the amount of work they're asked to take on...

Pathologists Respond to Criticism After Breast Cancer Testing Errors

Medscape reports Pathologists Respond to Criticism After Breast Cancer Testing Errors:

Ottawa, Ontario — Experts say staffing and funding constraints are making it difficult for pathologists to do their jobs and it is more likely that testing errors will occur. It is a problem, some say, that should encourage oncologists to remain vigilant and verify results.

"If test results don't fit with the usual pattern of the clinical problem or clinicians suspect the diagnostic test might be faulty, they should retest," Andrew Padmos, MD, chief executive officer of the Royal College of Physicians and Surgeons of Canada, told Medscape Oncology.

Jared Schwartz, MD, president of the College of American Pathologists, has this question for oncologists: "Do you know who is examining and interpreting your pathology?" He suggests that doctors adopt a more collaborative approach and work more closely with one another. "You have to have a relationship with the person looking at that slide. And clinicians, like patients, should have the ability to request a second opinion."

Wow, the situation in Newfoundland in Canada has really been a wakeup call for pathologists, both in Canada and elsewhere.  Although you never like to see errors, the improvements which have been suggested will be very beneficial; to address these concerns, Canadian pathologists have issued recommendations in the form of The 5-Point Plan:

• Certify each prognostic and predictive test performed by a lab.
  
• Start an external validation system, where test results from one lab are verified by an independent external lab.
  
• Use the national checklist for diagnostic immunohistochemistry, which is a quality-assurance system that covers test validation, staff training and competency assessment, standardization of operating procedures, and equipment maintenance.
  
• Create a national body — separate from government — to accredit all medical laboratories and ensure they meet quality and critical-mass standards
  
• Obtain immediate and ongoing support from federal, provincial, and territorial governments to address the critical workforce and resource shortages undermining laboratory medicine.

These seem pretty reasonable.  One might expect to see similar checks implemented in other countries including the U.S.

FDA to open offices in India, beginning international expansion

HealthImagingNews reports FDA to open offices in India, beginning international expansion:

The FDA plans to open two offices in India by next year, to be located in Delhi and Mumbai.

The new offices will be a part of the FDA Without Borders initiative, announced by FDA Commissioner Andrew von Eschenbach in March.

A growing number of medical devices and drugs are being exported from India to the United States, according to the agency.

The FDA “believes we can better help assure the safety and manufacturing quality of these products by having FDA personnel full time in India to work with our counterpart agencies there,” Christopher Kelly, a spokesman for the FDA’s office of international programs, told FDA News.

Kelly said the offices will help the agency “make better, more risk-based decisions on where to use our inspection resources—both in the field and at our borders.”

In addition to inspecting India-based companies, the FDA will work with private and public entities interested in certifying that products headed for the U.S. market meet its public health standards, according to Kelly.

The FDA also is in the process of finalizing an agreement with the Chinese government to open three offices there. Kelly said that the agency is hoping to have officials in Beijing, Shanghai and Guangzhou by the end of September.

Wow, that's amazing.  A U.S. regulatory agency opening offices overseas to help regulate products developed there for the U.S. market...  I guess it does make sense. 

India and China are a bit different, in that the primary contribution of India has been outsourced labor, while that of China has been outsourced manufacturing.  The effect of each on digital pathology remains to be seen...

HealthTronics Acquires UroPath

MarketWatch reports HealthTronics Acquires UroPath:

HealthTronics, Inc., a leading provider of urology services and products, today announced that it has acquired UroPath, LLC for $7.5 million.

Founded in 2003, UroPath is a leading provider of anatomical pathology laboratory services in the U.S.  In 2007, labs managed by UroPath processed over 400,000 specimens, serving more than 50 urology practices with over 450 physicians across 17 states.  UroPath's unique historical operating model focused on the patient benefits of a more disease-focused diagnosis capability for prostate health with greater involvement by the urologist who often acts as the primary care physician when dealing with prostate disease.

The consolidation in the pathology lab industry continues...

Awareness...

Ever since Aperio began, we've had two main challenges.  The first is obvious for any young business, we've had to build products and provide services to meet the needs of our customers.  And over the past seven years we've done our best, and have grown significantly as a result.  But the second is less obvious but equally important, we've had to create awareness of digital pathology and its benefits.

Over the past year, and especially in the past few months, the general awareness of digital pathology (and Aperio) really seems to have grown.  It has gone from a niche subject in a corner of pathology to a primary area of discussion; most pathologists now feel that digital pathology is the future of their field.  Evidence for this comes from all sides, and it is nice to see Aperio covered in major business press like NBR.  But it is perhaps even more significant to see grass roots mentions like Dr.Yang's MedBlog, in China, or Dr. Bhargava's MedSpin, in India.  And more and more we are seeing hospitals purchase digital pathology systems and feature them as new technology, such as this mention on Rhode Island's Hospital website.

An effort like this is never done, but it is gratifying to see this kind of progress.  Slowly but surely digital pathology is becoming mainstream, joining digital radiology as a major medical imaging modality.  Very cool.

Heart surgery pioneer dies

The Scientist notes Heart surgery pioneer dies:

Michael E. DeBakey, heart surgeon, inventor, teacher, and research advocate, died late last Friday, July 11th, at the age of 99.

DeBakey was "the greatest surgeon of the twentieth century," his colleague George Noon said in a statement from Methodist Hospital in Houston, where he spent most of his career.

During his 70 years as a surgeon, DeBakey performed over 60,000 heart surgeries at the Methodist Hospital and served as President, and later, Chancellor of the Baylor School of Medicine.

Dr. DeBakey was one of those few medical professionals whose work became public; in the early days of heart transplants he was practically a household name.

Two new Her2 tests appear on the market

This morning's news includes two new tests for Her2, first, Fox carries the story that Monogram announces commercial availability of the HERmark breast cancer assay:

Monogram Biosciences, Inc. today announced that, effective July 15, the HERmark Breast Cancer Assay will be available to physicians throughout the U.S. for assessment of HER2 status in patients with breast cancer. HERmark provides a precise and quantitative measurement of HER2 total protein and HER2 homodimer levels and will be offered as a CLIA-validated assay through Monogram's CAP-certified clinical laboratory.

HERmark is a proprietary diagnostic that accurately quantifies HER2 total protein levels and HER2 homodimerization in patients with breast cancer. HERmark is a CLIA-validated assay that is performed exclusively in Monogram's CAP-certified clinical reference laboratory in South San Francisco. Robust, accurate, sensitive and reproducible measurements of HER2 status are reported to physicians with a turnaround time of 7 days.

Also AJC.com reports on Invitrogen's SPOTlight test: FDA Approves Genetic Test for Breast Cancer:

A genetic test to determine whether a breast cancer patient is likely to respond to treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration.

The SPOT-Light HER2 CISH kit helps calculate how many copies of the HER2 gene, which regulates the growth of cancer cells, are in tumor tissue. A healthy breast cell should have two copies of the HER2 gene, but patients with breast cancer may have many more. Since the gene signals cells when to grow, divide and make repairs, too many copies may cause cells to grow and divide too rapidly.

Both of these Her2 assays would seem to be competitors for conventional IHC analysis performed using microscopy and/or with a digital image analysis application.