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FDA, 23andMe Open Up Market Pathway For DTC Genetics

The Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome is the first DTC genetic test to achieve sign off from FDA. More importantly, the marketing authority was awarded in a manner that could significantly streamline the path to market for future DTC carrier-screening assays.

FDA's decision to grant a 23andMe Inc. carrier-screening test marketing access opens up new possibilities for the company and for the broader direct-to-consumer genetic test market much sooner than expected.

Not only is the Google-backed firm's carrier screening assay for a rare disease called Bloom syndrome the first DTC genetic test to achieve sign off from FDA, but the clearance was awarded in a manner that will streamline the path to market for

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