23andMe gets FDA go-ahead to provide pharmacogenetic reports on statin

23andMe, which describes itself as a human genetics and biopharmaceutical company, will be able to provide pharmacogenetic (PGt) reports for the SLCO1B1 gene to include interpretive drug information for simvastatin.

The US Food and Drug Administration (FDA)’s 510(k) clearance means that there will be a modification of the labelling of the 23andMe’s drug transport report, removing the need for confirmatory testing.

Simvastatin is a medication used to help lower ‘bad’ cholesterol and fats, and to raise levels of ‘good’ cholesterol. As a result, the statin can help reduce the risk of heart disease, help prevent strokes and heart attacks.

According to ClinCalc​, simvastatin is one of the most commonly prescribed medicines in the US, with an estimated 36 million prescriptions distributed in 2020.

The SLCO1B1 gene influences the body’s response to simvastatin.  The SLCO1B1 protein helps transport certain medications from the blood into the liver, where they are processed for removal from the body. Specific DNA variants can affect how this transporter proteins functions.

23andMe stated that in certain ethnicities, up to 38% of people with the genotype have an increased likelihood of experiencing side-effects related to taking the medication. In particular, statin-associated musculoskeletal symptoms present a risk to individuals carrying the gene.

Though the information provided by 23andMe may be of concern to a patient carrying the gene and taking simvastatin, both the company and the FDA urged consumers that they should not start, stop, or change any course of treatment based on reports.

According to 23andMe, it carried out consumer comprehension studies, where over 95% of users understood that pharmacogenetics reports should not be used to change treatments without consulting their doctor. In addition, accuracy of its genetic testing for SLCO1B1 had to be measured against Sanger sequencing, where it achieved 99% concordance.

Currently, 23andMe offers pharmacogenetics reports based on three genes: CYP2C19, DPYD, and now SLCO1B1. CYP2C19 reports provide information about how certain DNA variants can influence how individuals react to citalopram and clopidogrel. DPYD reports do the same for a class of medications called fluoropyrimidines, which are used to treat certain cancers.

More broadly, the company has been stepping further into the biopharma side of its business by providing research functions that could prove useful in the development of new medicine.

At the beginning of this year​, 23andMe extended its collaboration with GSK to discover and validate novel drug targets using the former’s company’s genetic and health survey database. The partners revealed that GSK would be taking an immuno-oncology asset developed through the collaboration into Phase I studies.

Prior to this​, 23andMe and the Michael J. Fox Foundation for Parkinson's Research released genetic information from more than 52,000 volunteers around the world to enable discovery of modifiers of disease risk.