FDA Accepts 510(k) Application for 23andMe Health Report on Bloom Syndrome | GenomeWeb

NEW YORK (GenomeWeb) –The US Food and Drug Administration has accepted for review 23andMe's 510(k) application for a single-condition health report, the consumer genomics firm informed customers.

"Although the submission focuses on a single rare but serious inherited condition we report to customers — Bloom syndrome — it is an important step in our work with the FDA in the coming months," Kathy Hibbs, 23andMe's chief legal and regulatory officer, wrote in a blog post.

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