23andMe relaunches expanded genetic tests after 2-year, FDA-mandated hiatus
- Genetic testing upstart 23andMe announced on Wednesday that it will officially begin offering consumers who use its spit tests health data and carrier status information once again. The price of the service is also being doubled from $99 to $199.
- In November 2013, the FDA told 23andMe to stop giving its users health data, issuing the firm a stern warning letter that saying that its direct-to-consumer tests had not yet proven to be accurate and did not have proper marketing clearance.
- 23andMe has worked with regulators since then to get its flagship product, the Personal Genome Service (PGS), relaunched with the FDA's blessing. In February, the company won its first FDA authorization for its Bloom Syndrome test. And now, although 23andMe will begin offering health data to users once again, it won't contain the same breadth of information. Instead, the testing data will inform users of their genetic carrier status for 36 diseases, including cystic fibrosis and sickle cell anemia, which will be particularly useful for prospective parents.
It's been a long, at-times bumpy road for 23andMe. But the company is finally on track to realize CEO Anne Wojcicki's vision of a world where consumers have a right to their own genomic data, shorn of the involvement of any healthcare middlemen.
That doesn't mean the fight is over. The FDA is only allowing carrier status testing at this point, and Wojcicki still hopes to get expanded authorization to provide even more data and health analysis to PGS users for a larger number of diseases. And it's an open question at this point if the currently cleared carrier status data will have much market appeal beyond prospective parents who fear their children may be susceptible to a genetic condition.
But there's little doubt that Wednesday's announcement is a critical first step in the journey to realizing the company's broader dream, including matching users to personalized treatments and selling its data to pharmaceutical companies.
As BioPharma Dive reported in February, right after 23andMe's Bloom Syndrome test clearance, the company's efforts to convince regulators of its tests' accuracy (after the initial, gut-wrenching setback in 2013) is a master class in regulatory communication. 23andMe used rigorous clinical trials and persistent contact with the agency to regain its trust, and the firm has come out all the stronger for it.
In fact, the FDA's reclassification of carrier status tests from class III medical devices to class II in the wake of its interactions with 23andMe has industry-wide implications for status testing, nixing the need for premarketing authorization on top of (still-required) 510(k) clearance and de novo classification.
Last week, the company announced $115 million in new financing in a Fidelity-led round that placed a value of $1.1 billion on 23andMe.