FDA clears way for 23andMe to roll out health-related genetic testing

23andMe CEO Anne Wojcicki

Things looked pretty bleak for 23andMe two years ago after the FDA ordered the company to stop selling its genetic spit tests, saying that it didn't have sufficient data to prove the product's accuracy. But the company has been working hard to cut its losses and rebuild, and now it's taking another step in that direction as it launches a new FDA-approved product that provides customers with a suite of genetic reports.

The Mountain View, CA-based company is rolling out a service with more than 60 health, ancestry, wellness and personal genetic trait reports, including one that offers information about carrier status, or whether people have genetic mutations that could lead to a disease in their children. The carrier status product will cover more than 35 diseases ranging from cystic fibrosis to hereditary hearing loss, the company said on its website. Customers can purchase the product for $199, a $100 hike from the company's previous price point.

"We've worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe co-founder and CEO Anne Wojcicki said in a statement. "We are a better company with a better product as a result of our work with the FDA. This is an incredibly dynamic time in genetics and we're excited to be at the leading edge of bringing genetics directly to individuals as they begin to learn about their 23 pairs of chromosomes."

The news marks a milestone for 23andMe, which stood at the bottom of a slippery slope after falling out with the FDA two years ago. In 2013, the agency slapped the company with a warning letter for its $99 genetic tests, accusing it of selling its direct-to-consumer (DTC) spit tests without proper approval or data. 23andMe subsequently pulled its TV, web and radio ads for the test.

The company then charted a different course, striking deals with biopharma giants to diversify its offerings. 23andMe counts a number of pharma partnerships to its name, including one with Genentech for Parkinson's R&D and another with Pfizer ($PFE) to study the genetic profile of lupus patients.

23andMe's $199 genetic testing kit--Courtesy of 23andMe

23andMe is also getting in on drug development, launching a new therapeutics group earlier this year with Genentech vet Dr. Richard Scheller at its helm. The group will use human genetic data to identify new therapies for common and rare disease, speeding up drug development and bringing validated targets to partners, 23andMe president Andy Page told FierceDiagnostics at the time.

And slowly but surely, the company has gotten back in the FDA's good graces. In February, the company secured the agency's blessing to market its DTC carrier test for Bloom syndrome, a rare disease that primarily affects individuals of Ashkenazi Jewish descent. The FDA OK made the company the first to have a DTC genetic test cleared for consumers.

Meanwhile, 23andMe is roping in new funds to keep its engine running. Last week the company reeled in $115 million in Series E financing to support new business initiatives and R&D, bringing its total raised to $241 million.

- read 23andMe's statement
- here's the New York Times' take (sub. req.)

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