Answers from the Lab

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss the U.S. Food and Drug Administration’s (FDA) proposed rule on laboratory-developed tests (LDTs) and the comments Mayo Clinic submitted to the FDA.

Their discussion includes:

• How Mayo Clinic responded in its comments to the FDA on the proposed rule on LDTs.
• What comes next after the public comment period has closed effective Dec. 4.
• Quality management systems that are currently in place for laboratories.
• How changes in regulation could impact laboratory operations, patient care, access to testing, and innovation.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss current respiratory virus activity and the importance of staying up-to-date on preventive vaccines. 

Their discussion includes:

• The current outlook on COVID-19 cases and the importance of remaining vigilant with prevention efforts.
• The respiratory syncytial virus (RSV), pneumococcal, influenza, and shingles vaccines, and which groups of people should consider receiving them.
• Diagnostic tools and at-home testing options for respiratory viruses.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the one-year delay to clinical laboratory payment cuts recently passed by Congress and the importance of responding to the FDA’s proposed rule on laboratory-developed tests.

Specific discussion points include:

• How Congress passed the short-term spending package on Nov. 15 that included a one-year reprieve from planned Medicare cuts to laboratory services, and what this means moving forward.
• Why it is critical to submit constructive comments in response to the FDA’s proposed rule on laboratory-developed tests before the Dec. 4 deadline.
• What specific information would be helpful for laboratories to include in their comments to the FDA.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss key takeaways from Dr. Morice’s recent visit in Washington, D.C. 

Their discussion includes:

• How device manufacturers are evolving and collaborating within the changing landscape.
• The importance of submitting comments in response to the FDA’s proposed rule on laboratory developed tests.
• Staying engaged with legislative efforts around laboratory reimbursement fees.

Lisa Rimsza, M.D., explains how Mayo Clinic Laboratories' unique PM3CX test can accurately define subtypes of large B-cell lymphoma. Precise diagnosis is critical to choosing appropriate chemotherapy for these cancers.

Speaker 2: (00:32)
 Could you provide a brief background about yourself?

Speaker 2: (01:12)
 Would you give us an overview of the PM3CX test?

Speaker 2: (03:02)
 Which patients should have this testing? 

Speaker 2: (05:14)
 Is this test qualitative and RNA?

Speaker 2: (06:35)
 After determining if it's primary mediastinal large B-cell lymphoma or diffuse large B-cell lymphoma, does the test identify the cell of origin?

Speaker 2: (08:09)
 For patients diagnosed with diffuse large B-cell lymphoma, what are the treatment recommendations?

Speaker 2: (09:04)

Are there any other insights about this test that you'd like to share?

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss strategies for responsible innovation and how new standards for artificial intelligence (AI) safety will impact laboratory medicine and diagnostics.

Their discussion includes:

• Highlights of the Executive Order issued by President Biden on Oct. 30 that establishes new standards for safe and secure AI development. 
• Ethical considerations for laboratory leaders when applying AI algorithms.
• The importance of ensuring equitable access to powerful healthcare tools like AI.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the recent news of a possible cure for sickle cell disease, as well as gene editing therapies and their impact on the laboratory. 

Their discussion includes:

• Characteristics of sickle cell disease and current testing and treatment options.
• Advantages, challenges, and ethical considerations for gene editing tools.
• How gene therapies may impact the laboratory and the process for testing specimens.
• How the high cost of innovative therapeutics may accentuate disparities in care.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss the role and expansion of at-home testing. 

Their discussion includes:

• How home test kits for COVID-19 led to the expansion of at-home tests and telehealth options across the health industry.
• Understanding from a laboratory perspective the best use of future at-home testing opportunities.
• How the COVID-19 pandemic opened the door for more cross-collaboration and decentralization. 

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss how artificial intelligence (AI) has become a disruptive technology in the field of laboratory medicine, and how it can add value to patient care.

Their discussion includes:

• How the conversation around AI and laboratory medicine began, and how it has already made a mark on healthcare.
• Examples of AI applications within Mayo Clinic Laboratories.
• Considerations for responsible adoption of AI.

In this episode of “Answers From the Lab,” host Bobbi Pritt, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic, is joined by William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss current focus areas found across the diagnostics industry and what transformative technologies are being explored around the world.

Their discussion includes:

• What international laboratories and diagnostics companies are working on during this post-pandemic time.
• How large language models, artificial intelligence, and automation are accelerating changes in healthcare. 
• Considerations for thoughtful implementation of new technologies and the role pathologists and laboratorians play in keeping the needs of the patient first.