PHILADELPHIA — The American Association for Cancer Research (AACR) applauds the U.S. Food and Drug Administration (FDA) for issuing its final guidance on “In Vitro Companion Diagnostic Devices” and proposing its “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” Both are key steps to protecting our nation’s health and advancing personalized medicine.
“The recent announcements by the FDA are aimed at providing patients and their physicians with an important level of confidence and certainty with regard to the highly complex molecular and genetic information that these diagnostic tests are determining,” said Carlos L. Arteaga, MD, AACR president, and professor of medicine and cancer biology and associate director for clinical research at the Vanderbilt-Ingram Cancer Center of Vanderbilt University in Nashville, Tennessee. “In addition, these actions by the FDA will serve as a catalyst for incentivizing innovation, which is vital during this time of unprecedented scientific opportunity.”
Arteaga added, “As an organization that represents the entire continuum of research, from the laboratory to the clinic, including the clinical researchers and physician-scientists engaged in cancer patient care, the AACR looks forward to continuing to engage with the FDA to ensure that the molecular and genetic diagnostic tests that are being utilized by physicians (and patients) are based on solidly supported scientific evidence.”
The AACR will be providing input on the FDA’s proposed action during the open public comment period and urges the FDA to move quickly to issue final regulations once the comment period closes.