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COMPANY:
23andMe

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Other names: 23andMe | 23andMe, Inc | 23andMe Inc | 23andMe, Inc. | 23andMe Inc.
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23andMe receives FDA clearance for direct-to-consumer genetic test on a hereditary prostate cancer marker (23andMe Press Release)
"23andMe Holding Co...today received FDA clearance for a genetic health risk report on a hereditary prostate cancer marker...This is the Company’s third cancer risk report clearance, following the FDA’s prior authorization for 23andMe’s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report and its clearance for MUTYH-Associated Polyposis (MAP), a hereditary colorectal cancer syndrome...These two reports along with the new Hereditary Prostate Cancer (HOXB13-Related) report have been included by the FDA in a single 'Cancer Predisposition Risk Assessment System' regulation...These three 23andMe reports are the only direct-to-consumer genetic health risk reports for inherited cancers that have been authorized by the FDA for use without prescription."
FDA event
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23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) • 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis (MAP)