Prefer to read all five posts about the recent FDA Pharmacogenetics Test Report activity at once? We have compiled the full week here into this one post…Read More
Over the course of this week, we have covered a variety of related topics that arose from the recent FDA activity around direct-to-consumer (DTC) genetic testing. Because this is so new, much is yet unknown, so the best we can do today is speculate. However, we thought we would wrap up today with a few parting ideas to consider…Read More
The National Society of Genetic Counselor’s position statement on DTC testing from 2015 states that consumers have the right to make an informed decision on DTC genetic testing. As with other DTC tests based on SNP array technology, it is important that companies offering these tests are very clear when discussing their limitations. For instance, the 23andMe Personal Genome Service…Read More
One day following the Personal Genome Service Pharmacogenetic Reports (PGSPR) approval release, on Thursday, November 1, 2018, Jeffrey Shuren, M.D., J.D. (the Director of the FDA's Center for Devices and Radiological Health), together with Janet Woodcock, M.D., (the Director of the FDA's Center for Drug Evaluation and Research) published a statement to warn "consumers about genetic tests that claim to predict patient's responses to specific medications.” This statement specifically calls out tests…Read More
What Are User Comprehension Studies and Why are they Required by the FDA?
Unlike tests that are overseen by health care professionals where a conversation may take place about the meaning of results, direct-to-consumer tests bypass the traditional patient-doctor relationship and deliver results directly to patients (or consumers). A well-known example of a direct-to-consumer test is a pregnancy test that one may purchase at any pharmacy or similar retail store…Read More
While many of us were heading out to dish out candy (or tricks) to local goblins and superheroes this past Halloween, the FDA rounded out their suite of De Novo reclassification orders on DTC genetic testing. The latest announcement adds Personal Genome Service Pharmacogenetic Reports (PGSPR) to the existing regulations for Carrier Screening and Genetic Health Risk (GHR) tests (including a specific case of Genetic Health Risk Report for BRCA1/BRCA2)…Read More