CEO SUMMARY: Advances in molecular and genetic science have generated the first generation of diagnostic assays for clinical use. As these assays reach the public, acceptance is not immediate. Obstacles are many: ethical, cultural, clinical, and economic. Oncormed’s experience during the last five years provides valuable insights about the challenges of being first to the marketplace with cutting edge diagnostics
FUTURE DIAGNOSTIC ASSAYS BASED on genetic science represent the clinical laboratory industry’s “New Frontier.” These yet-to-be-developed assays may be the industry’s best opportunity to regain financial stability.
In the coming months and years, laboratory executives will begin encountering two new words: pharmacogenomics and polymorphisms. These are the technologies expected to underpin upcoming generations of diagnostic assays.
To get a peek into this future, The Dark Report recently visited Oncormed, Inc. in Gaithersburg, Maryland. Oncormed was founded in 1993 to offer services in two areas: gene characterization and molecular profiling.
Breast Cancer Test
Among Oncormed’s accomplishments was the development of a test, based on the BRCAI gene, for determining the susceptibility of women to breast and ovarian cancers. More importantly, during the past five years Oncormed also developed specialized resources to take cancer-related genetic discoveries from the research laboratory and develop them into clinically useful products.
“We want to accomplish our business goals through strategic partnerships,” stated Doug Dolginow, M.D., Oncormed’s President. “Several such partnerships are already in place. A further development is our impending acquisition by Gene Logic, Inc. within 30 days. The strategy was to match our proprietary technologies and clinical experience in pharmacogenomics with Gene Logic’s genomics and bioinformatics capabilities.”
The combined company expects pharmaceutical companies to be their primary customers. “The reason is simple,” stated Dr. Dolginow. “The current state of genetics-based diagnostics is still not ready for widespread clinical application. Our experience with breast cancer susceptibility testing illustrates why that is true.”
“First, such testing is not appropriate for every patient,” he said. “Individual patients must undergo a preliminary evaluation to determine if their background and circumstances warrant a genetics-based susceptibility test for breast cancer. Oncormed had to develop a protocol for identifying women whose background, family history of disease, and other factors indicated the appropriateness for our test. “It was at this stage of the process that we made a surprising discovery,” continued Dr. Dolginow. “At least 50% of the individuals who met o.ur protocol and were appropriate for this testing declined to go further. As it turns out, these individuals had many issues, each with no easy answer.”
Cancel Health Insurance
“They were concerned that insurance companies would learn of their susceptibility and figure out a way to deny coverage or cancel their health insurance,” noted Dr. Dolginow. “They had similar concerns about getting and keeping life insurance coverage.
“Even their kids were a consideration,” he said. “Many patients were worried that their susceptibility to breast cancer, once the tests were completed, would be used to deny their children health insurance and life insurance, now or in the future. Of course, some patients simply decided not to proceed with the test because they didn’t want to know what their susceptibility to breast cancer would be.”
Oncormed’s experience is mirrored by Genzyme Genetics, a leading provider of pre/postnatal genetics testing. When a patient is referred to Genzyme for genetics testing, counselors are provided to help prospective parents deal with the ethical and emotional issues that accompany the test results.
“Another factor inhibiting wider clinical use is that the underlying science for these assays is quite new,” added Dr. Dolginow. “That makes many clinicians hesitant to order the tests. Also, because of constraints on their time, most physicians have not yet been trained in the science and clinical applications of these tests.”
As a pioneer in offering genetics-based diagnostic testing, Oncormed’s experience demonstrates an essential point to clinical laboratory executives and pathologists. When genetics-based diagnostic assays of the future prove to be accurate, amazingly cheap, and highly effective at predicting, diagnosing, and staging various diseases, they add a new complication for laboratories: the need to address ethical, moral, and emotional issues with patients undergoing these tests.
(For further information, contact Doug Dolginow, M.D. at 301-208-1888 or email to: ddolginow@ oncormed.com.)
Introduction Of New Technology Is Like “Wildcatting”
NEW TECHNOLOGY from the research laboratory requires tremendous work before it can enter clinical use.
“Lots of laboratory research emerges before it is ready;• stated Doug Dolginow, M.D., President of Oncormed, Inc. “Right now there are huge pots of money chasing newly-developed technology in research laboratories all over the world.
“Research grant money competes with venture capitalists and private investors for any technology that looks promising,” he said. “On the plus side, venture capitalists are shrewd and good at evaluating risk. They tend to move viable technology into the marketplace faster than researchers backed by research grants.”
“But the process of transforming research technology into clinically viable products remains highly speculative,” added Dr. Dolginow. “It is exactly like wildcatting … drilling for oil.” Just like many exploratory wells come up dry before a gusher is drilled, so also does much of this new technology prove inappropriate for clinical use. “At Oncormed, our speciality is working with the research labs to apply the technology to live patients;’ he explained. “That is where we help reduce the financial risk while demonstrating the level of effectiveness this technology can have with patient populations.”