23andMe Consumer DNA Test Receives 510(k) Clearance for Updated Pharmacogenetics Report

The 23andMe consumer-direct health and ancestry DNA test has received 510(k) clearance for its pharmacogenetics report to include information about sensitivity to simvastatin, a drug used to treat high cholesterol and triglyceride levels, without the need for confirmatory testing.

This FDA clearance allows the company to modify the labeling of the previously authorized 23andMe SLCO1B1 Drug Transport report “to provide interpretive drug information based on genetic factors for simvastatin,” the company said.

The company says that certain ethnicities have up to a 38 percent likelihood of having the SLCO1B1 genotype, which can increase the risk of side effects from simvastatin, particularly statin-associated musculoskeletal symptoms.