During a briefing on July 9, the College of American Pathologists (CAP) discussed how Congress can promote patient safety without overburdening laboratories through enacting a diagnostic reform package that provides oversight of laboratory-developed tests (LDTs) and allows for innovation of new technologies. The Capitol Hill briefing featured top pathologists from around the country who provided background on LDTs and answered questions from congressional staffers.
For more than a decade, the CAP has advocated for an LDT regulatory framework that enhances patient safety, maintains access to quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists. Following the May 6 issuance of the Food and Drug Administration (FDA) LDT final regulation, the CAP is greatly concerned that the FDA is moving forward with its regulatory oversight plan for LDTs without making the additional changes needed to ensure both patient safety and access to accurate and innovative testing.
Donald Karcher, MD, FCAP, the CAP’s President and Joe Saad, MD, FCAP, President, Surgical Pathologists of Dallas spoke with congressional staff about these issues.
Overall, they sought to educate Congress about the underlying problems with the FDA rule and encourage legislative action that targets FDA oversight to tests representing the highest risk to patients while leveraging existing structures to maintain quality and access to lower-risk LDTs. The physicians explained what LDTs are and why they are important, the impact of the FDA’s diagnostic rule on the provision of LDTs and patient testing, and why the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, not the FDA final rule, provides the necessary oversight to ensure safe, quality laboratory tests for all patients.
Visit the CAP’s Laboratory-Developed Test Oversight webpage.