Laboratory Heads from World-Renowned Academic Medical Centers Urge OMB Not to Release FDA Guidance on the Regulation of Laboratory-Developed Tests (LDTs)

SALT LAKE CITY, July 16, 2014 (GLOBE NEWSWIRE) -- Leading diagnostic innovators and laboratory directors from the nation's most respected nonprofit, academic medical centers have issued a letter urging the Office of Management and Budget (OMB) not to release Food and Drug Administration (FDA) guidance for laboratory-developed tests (LDTs). Spearheaded by Edward R. Ashwood, MD, president and CEO of ARUP Laboratories and professor of pathology at the University of Utah School of Medicine, the letter states that FDA regulation would add yet another cumbersome layer to the already heavily regulated approval process for LDTs.

Many of the most technologically advanced academic clinical laboratories, including Harvard, Stanford, Yale, and Duke, criticize the FDA's intent to issue guidance that would regulate diagnostic tests as medical devices under the Food, Drug and Cosmetic Act (FDCA).

Diagnostic testing is not a device but a medical service vital to the practice of medicine, and laboratories are not medical device manufacturers. Therefore, lab services are not under the jurisdiction of the FDA but rather the Centers for Medicare and Medicaid Services (CMS) and state medical licensing boards.

Clinical laboratories have a long and groundbreaking history of leading innovative scientific discovery. Laboratory researchers caution that adding the FDA approval process to LDTs will compromise critical discoveries in the field of rare diseases, hamstring overall innovation, and delay life-saving patient care.

"Neither I nor my colleagues running nonprofit clinical laboratories in academic medical centers can stress enough the crippling domino effect the FDA approval process would have on diagnostic laboratory innovation within the laboratory environment," said Dr. Ashwood. "Current regulations allow flourishing laboratory research environments to facilitate sophisticated scientific discoveries. We support the current regulatory structure for LDTs."

To further underscore the extent to which LDTs are currently regulated, the statement notes: "LDTs, and the laboratories and personnel that develop and perform them, are highly regulated under a three-part framework consisting of federal regulations under the Clinical Laboratory Improvement Amendments (CLIA), state laws, and accreditation by deemed authorities such as the College of American Pathologists. As part of this oversight, clinical laboratory physicians and scientists ... perform careful inspections of lab facilities, exhaustive review test protocols and validation, and continually monitor laboratory performance."

Dr. Ashwood and his fellow colleagues hope to impress upon Acting OMB Director Brian Deese the overwhelming contributions that LDTs have made and continue to make to the health of a global society. Industry leaders point to the role LDTs have played in ameliorating world health crises such as HIV, SARS, and H1N1, as well as in ushering in the era of personalized medicine. For example, molecular diagnostic testing is now able to detect individual cancer pathways and determine their responsiveness or rejection to particular therapies, so physicians can eliminate the trial and error process, saving patients time and money.

"The current regulatory process for LDTs promotes safety and effectiveness within a cross-check of stringent requirements, while the lengthy, convoluted FDA-approval framework often delays, sometimes for decades, access to life-saving treatments," said Dr. Ashwood. "The current regulatory process keeps pace with medical innovation and gives patients access to critical, life-changing diagnostic discoveries. Further regulation is contrary to public health. The research being conducted right now in clinical laboratories will bring accurate treatments and cures to those who desperately need a medical solution. We must protect that future for millions of people."

About ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation's top university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®.