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23andMe Continuing GWAS into Disease Factors; Official 'Optimistic' Over FDA Talks

By Tony Fong

SAN FRANCISCO (GenomeWeb News) – Genetic testing firm 23andMe is continuing to leverage its database of patients using its tests to perform additional research, its senior director of research said Tuesday.

At the annual Burrill Personalized Medicine Meeting here, Joanna Mountain told audience members that the Mountain View, Calif., company is currently preparing studies in three areas.

One is a genome-wide association study meant as a follow-on to research published in June that used data from the company's database of 9,000 individuals genotyped through 23andMe's direct-to-consumer testing service. That study, which focused on "light-hearted" traits such as hair curl, freckling, and sneezing when exposed to sunlight, provided proof that by leveraging its large cohorts of patients, the company could make genetic discoveries, Mountain said.

The current research, the results of which will be unveiled later this year, will concentrate on dozens of genetic factors that may provide information on disease, she said, though she did not elaborate.

In addition, 23andMe is conducting research into the predictive power of its tests and research into how consumers and physicians may be using information from its tests, how well they understand the results, and whether they are sharing their genetic information, and if so, with whom, Mountain said.

She also provided an update on the firm's discussions with the US Food and Drug Administration. 23andMe is one of more than a dozen firms that received letters over the summer from the FDA claiming they were marketing unapproved genetic tests.

Mountain said that based on meetings with the agency since receiving its warning letter, "I'm feeling very positive about the future" of FDA regulation of DTC genetic tests. Asked for an assessment of whether FDA would provide regulatory certainty in a reasonable time frame, she said, "I'm more optimistic than I was a few months ago."

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