The American Clinical Laboratory Association (ACLA) has written a letter to the US Food and Drug Administration (FDA) regarding the FDA’s recent communications about pharmacogenomic (PGx) testing. The letter details the ACLA’s concerns that the FDA’s actions will have a significant impact on both patients and the field of PGx. The ACLA state their support for a legislative framework specifically for laboratory diagnostic tests (LDTs) and request a meeting with FDA leadership to discuss the matter further. You can read the full letter at the ACLA website.
Similarly, the Association of Molecular Pathology (AMP) has released a position statement on PGx testing, discussing the role of PGx in the precision medicine era and the standards which AMP believes that PGx tests should be held to.
The full statement can be accessed at the AMP website.