On April 6, 2017 the FDA Center for Devices and Radiological Health formally approved 23andMe’s Personal Genome Services Test as a Class II Medical Device. Approved tests include assessment of an individual’s genetic risk of...more
Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more
Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more
23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more
In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more
As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...more