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- CAP President Testifies During Congressional Hearing on Oversight of Laboratory-Developed Tests
On March 21, CAP President Donald Karcher, MD, FCAP, provided testimony 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.” Dr. Karcher firmly stated the CAP’s opposition to the Food and Drug Administration (FDA) proposed regulation on the oversight of laboratory-developed tests (LDTs) and advocated for policy solutions that target full regulation of only the highest risk LDTs.
“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.”
During the hearing, both members of the House and testifying witnesses agreed that they do not support the current FDA LDT proposed rule without significant changes. The majority of witnesses, including Dr. Karcher, called for Congress to consider the Verifying Accurate, Leading-edge, IVCT Development (VALID) Act. This legislation would overhaul the FDA’s approach to regulating in vitro clinical tests (IVCTs), including LDTs, and ensure uniform standards in clinical lab diagnostic testing.
Dr. Karcher’s full written testimony can be found at the following link. Watch the committee hearing here.