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.
Friday, September 20, 2019
Tuesday, September 10, 2019
We are happy to announce that Dr. Michelle Whirl-Carrillo has agreed to take on the position of Director of PharmGKB. Michelle has worked with the PharmGKB for over 15 years (not including a 1.5 year “sabbatical” at 23andme). She has served as lead curator, Assistant Director, and (since 2014) Associate Director. The PharmGKB grant has recently been renewed and Michelle has been named Director, effective at the start of September. Michelle has her undergraduate degree in Biology from MIT, and a PhD (working with Russ)in Biophysics from Stanford. Congratulations to Michelle and thanks for her willingness to help lead the PharmGKB into its 3rd decade! Teri and Russ (Co-PIs)