2 ms·
From the http://theranos.com/test-menu http://theranos.com/test-menu only HSV1 has been cleared by the FDA. They could do this through a regulatory loophole of
by MrQuincle 10y ago
From the http://theranos.com/test-menu http://theranos.com/test-menu only HSV1 has been cleared by the FDA. They could do this through a regulatory loophole of "laboratory developed tests". This loophole has also been used by Strand Life Sciences and Pathway Genomics and Admera Health according to a www.theverge.com article.
- HeyLaughingBoy 10y agoThat's a good point. I wasn't thinking of lab developed tests. I'm aware of them, but not of the specifics that the FDA expects in terms of safety & efficacy.