ISTOCK, BLACKJACK3DIt would have been remarkable news if the US Food and Drug Administration (FDA) had approved the breast cancer mutations test of 23andMe. The test includes three BRCA mutations that are a common cause of familial breast and ovarian cancer exclusively in Ashkenazi Jewish women. But according to numerous media reports, the FDA did just that earlier this month.
When the FDA approves a device, it means that “the agency has determined that the benefits of the product outweigh the known risks for the intended use.” Is the agency suggesting that there are benefits of testing Ashkenazi Jewish BRCA mutations in non-Jewish women? How does the FDA justify that the benefits of testing outweigh the known risks?
Well, it doesn’t. The FDA did not approve the test. Rather, the FDA classified the 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) into Medical Devices class II.
The FDA categorizes medical devices based on their risk profiles. Class I devices have the lowest risk and class III the greatest. Dental floss and elastic bandages are examples of class I, condoms and ...
