Personal Genome Service For Carrier Screening Emerges From 23andMe Work With FDA

Two years of conversations with FDA lead 23andMe back to the health care market with the launch of its Personal Genome Service, focused on carrier screening tests. The firm says its close engagement with FDA improved its customer communication and quality control.

Direct-to-consumer genetic testing provider 23andMe Inc.launches Personal Genome Service about two years after FDA forced the firm off the health care market, but also after the firm says its close engagement with the agency improved its customer communication and quality control.

The newly launched service is supported by disease carrier tests using an FDA-cleared saliva collection device, the Oragene DX model OGD.500.001

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