CAP Governor A. Joe Saad, MD, CPE, FCAP, discusses the FDA proposal to reclassify CDx assays. According to Dr. Saad, it becomes very confusing for pathologists and clinicians who are trying to determine what laboratory a test order should go to depending on which treatment is on the table, and it's complicated for laboratorians to ensure the right test is being run on the right equipment with the right reagents
For the full article click here: FDA Proposal to Reclassify CDx Assays May Broaden Opportunities for Dx Manufacturers, Experts Say