Pharmacogenetic (PGx) testing has recently come under fire from both the scientific and regulatory community for its lack of self-policing. But the new Association for Molecular Pathology (AMP) position statement outlining best practices for PGx testing may help calm the storm. Concerns Over PGx Testing PGx testing provides information to predict the likelihood of medication response and/or risk for adverse medication reactions based on a person’s genetic makeup. This information can be useful in guiding medication and dosing decisions. But while PGx testing continues to grow, it remains relatively new and unproven. And as with any new forms of testing, there are concerns about the clinical validity of particular PGx tests and the quality of PGx laboratory testing. The AMP guidelines are an attempt to allay those concerns by setting out four standards for laboratories providing PGx tests to follow to ensure that testing is carried out in accordance with best practices. PGx Health-Related Claims Must Have Well-Established Clinical Validity “[PGx] tests that are offered clinically should demonstrate evidence of clinical validity before being offered to patients,” the AMP guidelines state. “The drug-gene association must be robust and supported by strong scientific evidence,” which may include peer-reviewed literature, FDA drug […]