23andMe nabs FDA marketing clearance for direct-to-consumer genetic carrier test

23andMe's $99 genetic test.--Courtesy of 23andMe

23andMe scored FDA clearance to market its direct-to-consumer (DTC) genetic carrier test for Bloom syndrome, a crucial win for the company as it continues to make good with the agency and expand the reach for its genetic tests.

The Mountain View, CA-based company got a regulatory green light for its spit test kit and chip array platform for Bloom syndrome, a rare disease that primarily affects individuals of Ashkenazi Jewish descent. 23andMe picked up the clearance through the agency's de novo regulatory pathway, which is reserved for low- to moderate-risk devices with no market precedent. The FDA is also classifying autosomal recessive carrier screening tests as class II, allowing the products to forgo premarket review and clearing the way for similar devices to enter the market, the agency said in a statement.

"The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," said Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics and Radiological Health. "Today's authorization and accompanying classification, along with FDA's intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers."

Regulators based their decision on two studies with more than 200 samples, which showed that 23andMe's test could accurately identify patients who were carriers for Bloom syndrome. The agency also looked at studies demonstrating that people unfamiliar with the test could follow and understand its instructions.

Anne Wojcicki--Courtesy of 23andMe

But the FDA tacked on a few conditions to its marketing clearance, requiring 23andMe to explain in its product labeling what results might mean for prospective parents who want to see if they're carrying a genetic disorder. And if the company wants to sell their product over the counter, the agency is requiring 23andMe to provide information about how to contact a board-certified clinical molecular geneticist or the equivalent for pre- and post-test counseling. The company will not return test results to customers until it clears additional test reports and offers more products, 23andMe said in a statement.

"This is a major milestone for our company and for consumers who want direct access to genetic testing," 23andMe CEO Anne Wojcicki said in a statement. "We have more work to do, but we remain committed to pursuing a regulatory path for additional tests and bringing the health reports back to the U.S."

The clearance comes a little more than a year after the FDA slapped 23andMe with a warning letter for its $99 genetic tests, accusing the company of selling the product without approval or required data. 23andMe subsequently pulled its TV, web and radio ads for the test.

Since then, the company has forged new ground, inking deals with biopharma heavyweights to provide genomic data for drug development. Last month, Genentech paid 23andMe $60 million to access its genomic health reports for target discovery of new drugs for Parkinson's. The same week, 23andMe struck a database-driven collaboration with Pfizer ($PFE) for genomewide association studies, surveys and clinical trial recruitment.

- read the FDA statement
- here's 23andMe's release

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