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F.D.A. Eases Access to DNA Tests of Rare Disorders
The New York Times: The genetic testing company 23andMe on Thursday took a step toward being able to offer consumers health-related information again, winning approval from the Food and Drug Administration for a test for mutations that cause a rare disease.
The company, a pioneer in offering genetic tests direct to consumers from a sample of spit, stopped doing health-related testing in late 2013 after the F.D.A., in a scathing warning letter, said that such tests required the agency’s approval before they could be marketed.
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