The FDA said the tests are meant to provide genetic risk information but can not determine a person's overall risk of developing a disease or condition.
The FDA said it reviewed data for the company's tests under a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already marketed device. With GHRs, a person can bypass their doctor and test their predisposition to develop certain medical diseases or conditions without obtaining a prescription.
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"This is an important moment for people who want to know their genetic health risks and be more proactive about their health", said Anny Wojcicki, the CEO and co-founder of 23andME.
Hoping to streamline approvals, the FDA plans to exempt additional 23andMe genetic health risk tests from its pre-market review. The agency stressed that the product labeling should indicate that the test is not created to diagnose, determine treatment, or suggest anything about a user's state of health, the WSJ reported. Moreover, GHR tests that function as diagnostic tests were excluded from the FDA's marketing authorization. The special controls will also act as a benchmark for other companies developing similar tests.
"The FDA has embraced innovation and has empowered people by authorizing direct access to this information".
Consumers should be aware that false positives and false negatives are possible with these tests. They were also accused of selling genetic information to other sources and the scientific community, as well as failing to obtain approval from the FDA.