Published October 16, 2025

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, and William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, discuss recent regulatory and policy developments. Together, they explore:

• FDA rescinds rule on LDTs (00:48): The FDA has officially withdrawn its rule that would allow oversight of laboratory-developed tests (LDTs) as medical devices. The conversation explores what this decision means and what might come next for LDT regulation.
• PAMA reform update and new RESULTS Act (05:13): The newly introduced Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act aims to address reimbursement for laboratory tests.
• Getting engaged (12:37): Why it is important to understand new regulatory policies and help others understand their implications for the industry.

Resources

• Find past “Answers From the Lab” podcasts on LDTs and PAMA