23andMe embraces FDA regulatory pathway for consumer genetic tests

In a move that could help quell the controversy over consumer genetic tests, 23andMe says it has begun filing documents to seek a formal 510(k) clearance for 7 of its genetic tests. About 100 more will be submitted for clearance in separate installments by the end of the year.

As the Marin Independent Journal and others report, the firm already sells its consumer tests over the counter ($299 per person). But CEO and co-founder Anne Wojcicki asserts in the company's formal announcement of the filing that 23andMe is the first of the consumer genetic test makers to announce it was pursuing a formal FDA clearance and sees it as an important step in the field's evolution. The company said it has met with FDA officials regularly over the last year, meetings from which the company formulated its regulatory strategy now in play.

"FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care," Wojcicki said in a statement.

The company is among the first direct-to-consumer genetic testing outfits and it launched in 2006 with an instant high profile. Beyond the market space they helped create, Wojcicki is married to Google co-founder Sergey Brin, and both Google and Brin have invested substantial sums in the company, according to The Associated Press.

23andMe has resisted FDA regulation in the past, according to reports, after arguing its tests simply give consumers information rather than medical information. The company offers saliva-based kits that test a customer's genetic code for ancestry and future health details, though some have criticized the tests as being piecemeal and not very helpful. But others see them as becoming more relevant in helping to spot patients who have a larger risk of health problems that are treatable.

The FDA set the current process in motion in 2010, when it determined that certain types of diagnostic tests would be regulated the same way it monitors medical devices. Other than 23andMe, deCODE Genetics, Illumina, Knome and Navigenics were among companies that received letters from regulators mandating that they seek regulatory approval because the tests made health claims.

- read the company announcement
- check out that MIJ story
- here's the AP piece (via Time)
- consider the Bloomberg story

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