Cutting Edge Dx Approvals Threaten FDA’s Fuddy-Duddy Reputation

A trio of recent FDA product approvals in the diagnostics space have belied the agency’s traditional reputation for resisting medical innovation. Here’s the timeline for what has become an exciting season of ground breaking FDA approvals.

April 6: DTC Marketing of Genetic Tests

In the first week of April, 23andMe, a privately-held biotech firm based in Mountain View, California, issues a stunning announcement: The FDA has approved direct to consumer (DTC) marketing of the firm’s Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions, including late-onset Alzheimer’s disease, Parkinson’s disease, celiac disease and hereditary thrombophilia (harmful blood clots). The significance of the moment is not lost on the FDA. “These are the first DTC tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional,” notes Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

May 23: Keytruda

The FDA does something it’s never done before by approving a cancer drug administered on the basis of a tumor’s genomic features rather than where in the patient’s body it started. Richard Pazdur, acting director of the Office of Hematology and Oncology Products within the FDA’s drug division, calls the approval Merck’s Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor “an important first for the cancer community,” a sentiment echoed by the medical community.

June 22: Oncomine Dx Target Test

Less than a month later, the FDA issues premarket approval to Oncomine Dx Target Test, Thermo Fisher Scientific’s NGS-based companion diagnostic for non-small cell lung cancer (NSCLC) diagnostic that simultaneously screens for biomarkers associated with three FDA-approved therapies. Thermo Fisher claims that the test kit enables quicker matching for targeted therapies, through a single test rather than sequential testing and that the test will be available in the U.S. beginning in July. LabCorp’s Diagnostics and Covance Businesses, NeoGenomics Laboratories, and Cancer Genetics, are the first laboratories offering the test.