By Tim Welch
The biotechnology company Genentech filed a 31-page citizen petition on December 9, 2008 urging the Food and Drug Administration (FDA) to regulate all in vitro diagnostic tests aimed for use in therapeutic decision making. Under the current regulatory system used by the FDA, there are two types of in vitro diagnostic tests: those that are developed by device manufacturers and sold as diagnostic test "kits," and those that are developed by clinical laboratories for use within the laboratory ("in-house"). The FDA has regulated the former, while it has not regulated the latter. This allows developers of "in-house" diagnostic tests to make claims about the accuracy, validity, and effectiveness of their tests which are not subjected to the same scientific scrutiny from the FDA that is required of similar test "kits." Genentech argues in the petition that this regulatory inconsistency poses a serious threat to patients’ health because "the future of personalized medicine depends on the development of pharmacogenomic tests," and "it is critical that they are accurate, reliable, and clinically valid (i.e., effective)."
As genetic testing plays an increasingly important role in the diagnosis and treatment of disease, proper regulation of genetic tests is crucial. Claims made by developers of genetic tests regarding the validity of the test results are being used by physicians to guide therapeutic and diagnostic decision making. In some cases, these tests are used to diagnose or recommend treatment for patients with life-threatening diseases, such as some types of cancers. Therefore, it is crucial for patients’ health that FDA oversight be applied to these tests. However, Genentech alleges that the FDA allows many tests to go unregulated.
"In-house" tests were typically developed for diagnosing rare and uncommon conditions. However, genetic testing technologies are now being used for more common conditions and are being used to select treatment for life-threatening diseases.
Genentech suggests that the FDA fix this situation by regulating all in vitro diagnostic tests and employing the risk-based classification system used to regulate medical devices. By placing all developers of in vitro diagnostic tests on an even playing field, the FDA will eliminate disincentives in the market that currently result in very few FDA-approved genetic tests. Successful FDA oversight of all in vitro genetic diagnostic tests is crucial in facilitating a safe and effective future for personalized medicine in the treatment of serious life-threatening diseases.