In comments submitted to the U.S. Food and Drug Administration (FDA), ASCO expressed its support for the agency’s draft guidance, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).”
ASCO also strongly recommends that the agency proceed with regulatory authority in a way that helps ensure ongoing innovation in the field of molecular testing, as well as timely patient access to validated molecular diagnostics that help improve use of precision medicine. Increasingly, multiplex genomic and proteomic tests are being used to guide therapy selection for people with cancer.
“ASCO believes that the tests used to detect those abnormalities must be of the highest quality and thoroughly validated before being offered to doctors and patients,” ASCO President Peter Paul Yu, MD, FACP, FASCO, wrote. “Our patients depend on high- quality tests as much as they depend on carefully studied, safe, and effective drugs to achieve the best possible outcomes.”
Read the FDA’s draft guidance on LDT regulation at www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416685.pdf. ■