Today, College of American Pathologists (CAP) President Donald Karcher, MD, FCAP, provided testimony (PDF) to the House Energy and Commerce Subcommittee on Health during a hearing entitled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of FDA’s Proposed Rule.”
“The CAP believes a balanced, risk-based approach to the federal oversight of laboratory-developed tests (LDTs) is needed to promote continued innovation, meet patient needs, and ensure that each test is valid, safe, and reliable,” Dr. Karcher said in his statement for the record. “Through the years, the CAP has advocated for three main principles for LDT oversight: protect patients, ensure continued access to safe and innovative diagnostic tests, and develop a framework that is the least burdensome for pathologists and their laboratories.”
“The CAP supports a legislative and regulatory framework for the oversight of LDTs that acknowledges the significant and important technological diagnostic advancements in medicine and the changing health care landscape. Because LDTs have been and continue to be critical for the advancement of medicine, the CAP cannot support the current Food and Drug Administration’s (FDA) LDT proposed rule without significant changes. The current proposal will reduce the number of highly accurate LDTs available to patients and further delay timely patient care. The regulatory activities in this space must ensure that patients continue to have access to high-quality, reliable, accurate, and innovative diagnostics.”
Dr. Karcher’s full written testimony can be found at the following link (PDF). Watch the committee hearing here.