In this special episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the final rule issued by the U.S. Food and Drug Administration (FDA) on April 29, 2024, to make explicit its plan to regulate laboratory-developed tests (LDT) as medical devices under the Federal Food, Drug, and Cosmetic Act.

Their discussion includes:

• Highlighting key points, exceptions, and the phased implementation plan of the final rule.
• How the FDA’s final rule compares to its proposed rule from last year.
• How the news may impact laboratories, health systems, health agencies, and manufacturers.
• Uncertainties that still remain regarding the future of laboratory-developed tests.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Division of Clinical Microbiology at Mayo Clinic, is joined by Robin Patel, M.D.,director of the Infectious Diseases Research Laboratory and co-director of the Bacteriology Laboratory at Mayo Clinic. They discuss antimicrobial resistance and why it’s a major global health concern.

Specific topics of discussion include:

• Background information on antimicrobial resistance and why it is a growing threat to global health.
• What is being done to address the problem, and Dr. Patel’s work as a member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
• How laboratorians and pathologists can advocate for continued action on antimicrobial resistance.

David S. Viswanatha, M.D., explains how Mayo Clinic Laboratories' new assay provides rapid, definitive diagnosis of VEXAS, a recently identified syndrome affecting older men. Early diagnosis is key to managing the condition, which severely impacts multiple organs and blood.

(00:31)
Could you please provide a little bit about yourself and your background?

(01:30)
Would you please share a brief overview of the UBA1Q assay?

(02:13)
Would you provide an overview of VEXAS syndrome?

(05:30)
When is this testing recommended during care for patients who have a suspected inflammatory condition or VEXAS syndrome?

(06:38)
What advantage does this assay provide over other methodologies?

(10:13)
Could you share further why diagnosis is so important for these patients?

(12:40)
Is there anything else you'd like to comment about the assay?