Personal Gene Tests Face Stricter Oversight After 23andMe, Inc.

23andMe Inc.’s clash with U.S. regulators over the direct sale of its gene analysis service to consumers signals stiffer oversight of thousands of tests in an industry predicted to increase fivefold in size. The Personal Genome Test from Google-backed 23andMe gives individuals an analysis of their risk of hundreds of diseases based on DNA data. The Food and Drug Administration’s action last month to ban sales of the service suggests the agency is expanding its focus to tests it hadn’t regulated, said Jeff Gibbs, an attorney with Hyman Phelps & McNamara in Washington.

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