23andMe Granted New FDA Clearance to Provide Interpretive Drug Information for a Commonly Prescribed Cholesterol Medication
The 510(k) clearance modifies the labeling of the previously authorized 23andMe SLCO1B1 Drug Transport report, removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for simvastatin.
- The 510(k) clearance modifies the labeling of the previously authorized 23andMe SLCO1B1 Drug Transport report, removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for simvastatin.
- Simvastatin is a medication in the statin family of drugs, commonly prescribed to lower cholesterol to help reduce the risk of heart attack and stroke.
- In 2020, simvastatin was the second-most commonly prescribed statin, and the thirteenth-most commonly prescribed medication overall, in the U.S.* A variation of a particular gene, SLCO1B1, influences the bodys response to simvastatin.
- 23andMe underwent rigorous analytical validation in order to meet FDA requirements to remove the need for confirmatory testing of the 23andMe pharmacogenetics report for SLCO1B1.