Direct-to-consumer genetic testing in trouble October 17, 2008
Posted by Dr. Bertalan Meskó in genetics.trackback
Have you seen the new FDA warning letter?
Last week, the FDA made a positive move. A warning letter sent to the Laboratory Corporation of America, the nation’s second-largest clinical laboratory company, states that the company’s OvaSure test is illegally marketed and poses a potential public-health risk. Introduced in June, the test measures six proteins in blood to assess whether or not a women has ovarian cancer. Because the test was not designed, developed, and validated by the company, and since it is intended for use as a diagnostic tool, the FDA states that the product requires proof of efficacy.
Although critics worry that overregulation might impede innovation, most agree that genetic testing is in its infancy and needs further validation in reproducible large-scale clinical studies. The long-term hope is that genetic testing will change medicine from treatment to prediction and prevention. Now is the time for a broad debate to decide the appropriate level of regulation for direct-to-consumer genetic tests, so that the results of such tests can truly inform care.
Further reading:
Some points in defense of LabCorp: This is not a genetic test, but rather a test using biomarkers in serum (leptin, prolactin, osteopontin, insulin-like growth factor II, macrophage inhibitory factor, and CA-125). Also I am unsure that it is marketed as DTC, – I think maybe it is marketed towards doctors. Lastly I believe the claim made by FDA was that “Based on the information collected, FDA has determined that the OvaSure™ is a test that was designed, developed, and validated by investigators at Yale University and not LabCorp.” Thus, my interpretation would be that they are crticized not for using a bad test (the test looks good based on the original publication !), but rather for not doing their own inhouse validation and the lack of regulatory paperwork.