College of American Pathologists (CAP) President Donald Karcher, MD, FCAP issued the following statement regarding the release of the Food and Drug Administration (FDA) final regulation on the oversight of laboratory-developed tests (LDTs):
“The CAP remains 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. While we recognize that the FDA adopted the CAP’s recommendation to allow LDTs offered prior to the rulemaking going into effect to remain under its enforcement discretion policy, the FDA must do more to recognize the realities of clinical laboratory testing and pathology practice in the 21st century.
"LDTs have been critical for the advancement of medicine and contributed to the evolution of modern scientifically-based health care services. Today, LDTs continue to have a critical role in scientifically-based diagnostics and clinical care for patients. While full FDA oversight of the small number of LDTs posing the highest risk to patients (tests using unconventional methods and/or non-transparent algorithms, with no opportunity for external verification of accuracy) may be warranted, many pathologists and laboratories will be forced to soon decide whether they will continue to offer lower-risk, well-validated and high-quality LDTs given the great cost and regulatory burden of the FDA’s new rules.
"We urge the FDA to reconsider the CAP’s prior feedback in light of the real-world effect its strict regulation will have on pathologists and laboratories meeting the needs of a diverse patient population across the United States. Importantly, FDA must conduct a massive outreach and education campaign on how laboratories can meet these regulatory requirements and still care for patients as the new rules are implemented.”
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.