To get the latest news on the regulations for laboratory developed tests (LDTs), sign up for “Emerging Models for Regulating Laboratory-Developed Tests,” an AACC-sponsored webinar on Nov. 3. Speakers James Nichols, PhD, DABCC, FACB, and Peter Kazon, JD, plan to provide updates about the Food and Drug Administration’s (FDA) new draft guidance on LDTs.

Nichols is the medical director of clinical chemistry at Vanderbilt University School of Medicine in Nashville, Tennessee, and chair of AACC’s Government Relations Committee. Kazon is senior counsel at Alston & Bird in Washington, D.C.

Laboratorians need to be aware of the proposed FDA changes and the impact of those changes on their operations, Nichols told CLN Stat.

With respect to LDTs, “FDA is essentially proposing to regulate clinical laboratories like manufacturers. The proposed changes will certainly alter the way laboratories operate, and there are a number of unanswered questions as to cost and challenges of verifying analytical and clinical validity of the LDT,” he noted.

As it stands now, FDA has received both public and professional society comments on its proposed changes to LDT regulation. Earlier this year, FDA and the Centers for Medicare and Medicaid Services announced the formation of an interagency task force to address the overlap in LDT oversight between the two agencies. 

“While each society has slightly different definitions for categorizing LDTs as high versus low risk, all agree with using a transparent process for categorizing test risk that uses public input and continues some level of enforcement discretion for the lowest-risk tests,” Nichols said.

During the webinar, Nichols plans to discuss proposals to the FDA regulatory framework for LDT oversight from the Association for Molecular Pathology, the College of American Pathologists, and the Diagnostic Test Working Group, a committee of manufacturers and a few high-volume reference labs.

“I will also describe several of the unanswered questions as FDA moves to implement changes to current enforcement discretion over LDTs,” Nichols said.

Register online for AACC’s upcoming webinar, “Emerging Models for Regulating Laboratory-Developed Tests.”