23andMe’s consumer pharmacogenetics report no longer requires follow-up testing for certain medications

ByAngela
23andme’s-consumer-pharmacogenetics-report-no-longer-requires-follow-up-testing-for-certain-medications

https://www.mobihealthnews.com/news/23andmes-consumer-pharmacogenetics-report-no-longer-requires-follow-testing-certain-medications

23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing.

WHAT HAPPENED

This action updates a De Novo approval granted to the consumer genomics company in late 2018.

 » ….