23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, sought U.S. regulatory approval for a genetic testing service that may help people assess their risk for developing cancer and Alzheimer's.
The submission with the Food and Drug Administration will cover seven tests, which 23andMe isn't specifying, Ashley Gould, the Mountain View, California-based company's chief legal officer, said today in a phone interview. The tests are part of a service that tells users whether they carry a disease, are at risk of a disease and would respond to a drug, she said.
"The result that you get when you review a report, the FDA wants to ensure that's a valid result," Gould said.
Wojcicki, the wife of Google co-founder Sergey Brin, started 23andMe about six years ago, and her husband used the saliva kit to determine he had a gene that makes him susceptible to developing Parkinson's. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers.
"23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust," Wojcicki said in a statement on the company's website.
Such types of genetic tests may become a $25 billion annual market in the U.S. within a decade, highlighting the need to identify which work best, UnitedHealth Group Inc. (UNH), the largest publicly traded U.S. health insurer, has said. While UnitedHealth said such tests hold great promise, the insurer in a March report raised concern about accuracy and affordability.
FDA Application
23andMe said it submitted the FDA application today for the least stringent of two types of medical device reviews. The company plans to submit "several" more applications by the end of this year, Gould said.
DNA Genotek Inc. (OSUR), a company bought last year by OraSure Technologies Inc., makes the FDA-approved saliva kit. Gould said 23andMe is seeking approval of the process for analyzing and interpreting DNA results for patients.
"The FDA's role and oversight of direct-to-consumer genetic tests are designed to ensure that manufacturers are delivering on their medical claims and providing the public with safe and effective medical devices," Erica Jefferson, a spokeswoman for the agency, said in an e-mail
Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions, Gould said.
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