The conditions in question are Parkinson’s disease, late-onset Alzheimer’s, Celiac disease, Alpha-1 antitypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, G6PD, hereditary hemochromatosis and hereditary thrombophilia.
“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” 23andMe CEO and co-founder Anne Wojcicki said in a statement. “The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics.”
What the clearance doesn’t cover are using the tests as a diagnostic procedure for things like BRCA (gene mutations that can lead to breast and ovarian cancer), which would result the preventative removal of a woman’s breasts or ovaries.
What the clearance doesn’t cover are using the tests as a diagnostic procedure for things like BRCA (gene mutations that can lead to breast and ovarian cancer), which would result the preventative removal of a woman’s breasts or ovaries. The FDA stresses that users should still consult a physician before taking any treatment steps and that these tests shouldn’t replace professional diagnoses.
The FDA’s reasoning for its approval seems sound, though. “Authorization of the 23andMe genetic health risk tests was supported by data from peer-reviewed, scientific literature that demonstrated a link between specific genetic variants and each of the 10 health conditions,” the statement says. “The published data originated from studies that compared genetic variants present in people with a specific condition to those without that condition.”
This clearance could pave the way for more companies to offer genetic testing of their own. The FDA says that following a one-time FDA review, the proposed exemption would “allow other, similar tests to enter the market as quickly as possible and in the least burdensome way.”
That doesn’t mean Theranos is going to suddenly regain legitimacy. After all, you need sound science as a basis for this, and that’s allegedly the opposite of what CEO Elizabeth Holmes and Co. had on offer.