FDA Removes Need for Confirmatory Testing for 23andMe Pharmacogenetics Report

California-based genetic testing company 23andMe has received an expanded 510(k) clearance from the FDA for its pharmacogenetics report for clopidogrel, a drug prescribed for certain heart conditions, and citalopram, a depression med.

The clearance modifies the labeling of the already-authorized CYP2C19 drug metabolism report, removing a previous requirement for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for the two drugs.

The pharmacogenetics report can assist doctors in prescribing the two drugs, which can cause side effects in patients with certain genetic variants.