The U.S. Food and Drug Administration (FDA) has granted 23andMe 510(k) clearance for its pharmacogenetics report for the SLCO1B1 genetic variant to provide interpretive drug information 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 in the U.S.
A variation of a particular gene, SLCO1B1, influences the body’s response to simvastatin.
In certain ethnicities, up to 38% of people have a SLCO1B1 genotype that increases the possibility of experiencing side effects related to taking simvastatin, particularly statin-associated musculoskeletal symptoms risk.
In addition to providing interpretive drug information, the new FDA clearance also removes the requirement for confirmatory testing.
“This is an important win for consumers, as they will have access to critical information on how they may respond to a commonly prescribed medication, based on their genetics,” said Noura Abul-Husn, M.D. Ph.D., Vice President of Genomic Health at 23andMe.
“A complete health picture requires a number of inputs, including genetics, which too often is left off the table in healthcare. With this clearance, we are continuing to champion access to actionable health information so that everyone can benefit from a personalized health care experience and avoid negative side effects of medications where possible.”