23AndMe, Inc.

23AndMe, Inc. develops genetic health risk reports and pharmacogenetic testing under its Personal Genome Service (PGS). These include assessments for hereditary conditions such as BRCA1/BRCA2 mutations, hereditary thrombophilia, MAP, and hereditary prostate cancer (HOXB13-related). Pharmacogenetic reports analyze genetic variations affecting drug metabolism and response. All products are delivered as at-home testing kits with digital reporting.

The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.