– what has and hasn’t been reviewed and approved
Genetic testing to enhance patient outcomes is a hot topic in the news this year, and the FDA plays a role in reviewing and approving such tests for use. Some of the claims made by providers have not been reviewed by the agency, which resulted in this safety warning on 01NOV2018. These tests may be offered through health care providers or directly to the consumer and they claim to predict which medication is most effective or has the fewest side effects for a variety of conditions. The warning also discusses software programs that interpret genetic information from a separate source and claim to provide similar predictions. It provides specific recommendations for patients, providers, and test manufacturers/developers for how to proceed, as well as links to more information about approved tests. The agency is also looking into investigating potential compliance issues with specific developers.
On the positive side, CDRH just approved a direct to consumer test from manufacturer 23 and Me (the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports) that provides specific information about genetic variants that may affect a patient’s ability to metabolize some medications (read the press release here). Extensive study over the past 25 years has demonstrated a clear link between certain genetic variants of enzyme systems that metabolize and help eliminate drugs from the body. The application for this test provided sufficient data to enable the agency to grant approval through the De Novo pathway (DEN1800028, you may also want to read the classification order for the test, which indicates it is a Class II device). The classification order also lists the genetic variants of isozymes that are approved for reporting in the test results. The new regulation called for in the order will cover pharmacogenetic assessment systems, and this new class II category should help simplify future applications for similar systems through the 510(k) premarket notification system. Sponsors of such applications would be smart to review the classification order for the special controls approved for the 23 and Me test.
Text Copyright © 2018 Katrina Rogers