Answers from the Lab

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss recent outbreaks in vaccine-preventable diseases. Specific topics of discussion include:Recent increases in outbreaks of infectious diseases, such as pertussis, measles, and polio. The serious side effects of the diseases. What’s fueling the resurgence of these diseases.Testing options for infectious diseases and resources for physicians.

While confirmed cases for many respiratory illnesses are currently low, they will almost certainly spread as we move further into fall and winter. Now is the perfect time to prepare and take steps to protect yourself from everything from COVID-19 and influenza to RSV and the common cold. 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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss practical steps for protecting yourself and innovations that are making testing and vaccination easier. Specific topics of discussion include:The importance of vaccinations and preventive measures to keep you healthy. Innovations that are making it possible to provide more at-home options for vaccination and testing and when these options will be most beneficial. The latest status on avian influenza.

Megan Hoenig, M.S., M.P.H., CGC, explains how Mayo Clinic Laboratories' unique hypermethylation analysis (Mayo ID: MLHPB) provides critical adjunct information for managing Lynch syndrome. That genetic condition increases patients' risk for many kinds of cancer.Speaker 3: (00:32) Could you provide our listeners with a little bit about yourself and your background? Speaker 3: (01:27) Could you give an overview of our MLH1 hypermethylation, also referred to as MLHPB in our test catalog? Speaker 3: (02:48) Can you talk about why your team thought it was really important to develop this test? Speaker 3: (04:03) What patients would this testing really benefit? Speaker 3: (06:10)How are the results used in patient care? Speaker 3: (07:56) Anything else you would like our listeners to hear about MLHPB?

From cyberattacks to utility failures, technology disruptions are a growing risk in an increasingly digitized and automated laboratory environment. Planning for technology disruptions positions laboratories to embrace the full power of automation, artificial intelligence, and digitization while still meeting critical patient care needs during an outage. 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 John Osborn, operations administrator in the Department of Laboratory Medicine and Pathology at Mayo Clinic, who helps lead efforts to prepare for technology disruptions in the laboratory. Specific topics of discussion include:Immediate considerations when a technology disruption occurs and prioritizing the restoration of systems and processes. How to create strategies and tools to guide decision-making and operations amid multiple outage scenarios. Lessons learned from real life examples, including the importance of clear communication, empowering lab directors to make decisions, and pre-planning for recovery. Preventive measures and risk mitigation strategies you can take today to make it easier to respond during a future incident.

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 Alicia Algeciras-Schimnich, Ph.D., a professor of laboratory medicine and pathology at Mayo Clinic and co-director of the Clinical Immunoassay Laboratory. They discuss Mayo Clinic’s plasma test for detecting Alzheimer’s disease and how it supports increased access and early detection. Specific topics of discussion include:The phospho-Tau 217 plasma test (Mayo ID: PT217) used to evaluate individuals aged 50 years and older with symptoms of cognitive impairment who are being assessed for Alzheimer’s disease and other causes of cognitive decline.The benefits of a blood test versus the other diagnostic methods for Alzheimer’s disease.Why early diagnosis is so important for quality of life and treatment planning.How tests like Mayo Clinic Laboratories’ PT217 may change the landscape of Alzheimer's research and treatment.

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 Dong Chen, M.D., Ph.D., chair of the Division of Hematopathology in the Department of Laboratory Medicine and Pathology at Mayo Clinic. They discuss rare and inherited platelet disorders and esoteric laboratory testing of hematologic disorders.Specific topics of discussion include:How these rare disorders are diagnosed through laboratory tests.Why platelet transmission electron microscopy is considered the gold standard for diagnosing disorders like Hermansky Pudlak syndrome, Wiskott-Aldrich syndrome, Chediak Higashi syndrome, and Jacobson/Paris-Trousseau syndrome.The process involved with developing and validating the PTEM test (Mayo ID: PTEM) at Mayo Clinic.The importance of ongoing research and advocacy to enhance care for patients with rare platelet disorders.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the latest news in pathogen activity and how these viruses serve as an important reminder of the role of the public-private lab partnership.Their discussion includes:How the United States addresses emerging pathogens and the importance of a partnership between public health laboratories and private or clinical laboratories.Why access to testing is vital to prevent pathogen outbreaks and pandemics.The need for an effective legal framework around pandemic and hazard preparedness.Current diagnostic efforts around mpox, bird flu, and COVID-19, and opportunities to expand at-home testing.

Matthew Schultz, Ph.D., and Amy White, M.S., CGC, explain how Mayo Clinic Laboratories' unique urine assay (Mayo ID: SORD) screens for peripheral neuropathy arising from SORD gene variants. Although recently identified, SORD-related peripheral neuropathy is fairly common.(00:31) Would you share a little bit about yourself and your background? (01:11) Could you provide us with an overview of this particular peripheral neuropathy? (03:09) Can you share the background as to how your team learned about this condition and how you considered testing for it? (04:42)Would you explain what you saw when you performed the urine test on the first patient? (05:26) Were you able to test additional patients with this condition? (06:09)Could you expand on why this urine test is important? (07:20) How does a health care provider order urine testing for SORD deficiency? (07:59) How does this new SORD urine test complement the existing Mayo Clinic Laboratories test menu? (08:55)Could you summarize the benefits of ordering this SORD urine test at Mayo?

In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by special guest Donald Thomas, M.D., a rheumatologist and lupus researcher. They discuss how Mayo Clinic Laboratories’ suite of innovative lupus testing, offered in collaboration with Progentec Diagnostics, is enhancing the care and quality of life for patients affected by systemic lupus erythematosus (SLE).Their discussion includes:Symptoms of lupus and characteristics of the complex disease process.The role of laboratory testing in diagnosing and managing long-term treatment for patients with lupus.Dr. Thomas’ clinical experience using the Progentec aiSLE® DX Lupus Flare Risk Index and Lupus Disease Activity Index for his patients, and how these tests have enhanced collaborative treatment planning.Why these novel tests are a major step forward in expanding diagnostic tools and improving care for patients living with SLE.

John Mills, Ph.D., and Divyanshu Dubey, M.B.B.S., explain how Mayo Clinic Laboratories' new test panel can distinguish among various potential causes of demyelinating neuropathies. Test results are important for managing these devastating autoimmune conditions.Show notesSpeaker 3: (00:32) Would you provide a little background on yourself, Dr. Mills? Speaker 3: (01:19) Dr. Dubey? Speaker 3: (02:07) Can you give a brief overview of our demyelinating test and recommended use? Speaker 3: (03:52) Can you discuss how this new test will assist in a patient's journey? Speaker 3: (05:46) Can you tell us some of the unique features of this test? Speaker 3: (08:09) Dr. Dubey, as a neurologist, how does this test set us apart in the market? Speaker 3: (11:05) Could you summarize the benefits of having both a demyelinating panel and an axonal panel? Speaker 3: (11:40) Why should a patient have an axonal or demyelinating test versus a sensory and motor test for peripheral neuropathy?

In this episode of “Answers From the Lab,” William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, is joined by special guests Bernard Rubin, D.O., MPH, chief medical officer of Progentec Diagnostics, and Melissa Munroe, M.D., Ph.D., chief scientific officer and principal investigator of Progentec Diagnostics. They discuss Mayo Clinic Laboratories’ suite of innovative lupus testing, offered in collaboration with Progentec Diagnostics, for patients affected by systemic lupus erythematosus (SLE).Their discussion includes:The Progentec aiSLE® DX Lupus Flare Risk Index that uses an algorithm to calculate a flare risk index, which assigns a score based on a patient's risk of a forthcoming lupus flare.The Progentec aiSLE® DX Lupus Disease Activity Index that characterizes a patient’s current disease activity into low, moderate, or active states.How these two tests were developed and for whom they are recommended.Why these tests are a significant development and how they enhance the quality of life for patients living with SLE.

Ann Moyer, M.D., Ph.D., explains how Mayo Clinic Laboratories' unique genetic tests identify patients at high risk of severe reactions to fluoropyrimidines — a type of chemotherapy drug. Test results can guide clinical decision-making for safer cancer treatment.Speaker 3: (00:32) Would you tell us a little bit about yourself and your history with this testing? Speaker 3: (01:25) Would you tell us a little more about this assay? Speaker 3: (04:57) Which patients should have this testing and when should it be performed? Speaker 3: (05:30) What alternative tests exist and how do they compare? Speaker 3: (06:28) How are the results used in patient care?

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories, to discuss the latest advancements in Alzheimer’s disease testing and treatment.Their discussion includes:Why there is an increased focus on Alzheimer’s disease in the diagnostics industry.The development of groundbreaking blood tests that can detect Alzheimer’s-related biomarkers.The importance of accurate testing to avoid false positives.The role of laboratory scientists in guiding appropriate test usage.The promising new treatment options and the need for informed decision-making in a patient’s healthcare journey.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They cover current trends, pain points, and opportunities for growth in the lab and diagnostics market.Their discussion includes:Insights from Dr. Morice’s participation in an Advisory Board webinar about 2024 lab market trends.Why there is an increased demand for laboratory testing.The opportunities that come with digital pathology, at-home testing, and remote diagnostics.

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 Matthew Binnicker, Ph.D., professor of laboratory medicine and pathology and clinical virologist at Mayo Clinic. They discuss the upsurge of mpox cases, particularly in Africa, and why the World Health Organization has declared it a public health emergency of international concern.Specific topics of discussion include:Background information on the monkeypox virus, and the current outbreak situation.What is contributing to the rapid spread of mpox in the Democratic Republic of the Congo and neighboring countries.How the current mpox outbreak compares to the global outbreak in 2022, and lessons learned that could be applied today.Testing options for diagnosing mpox.What can be done to control the spread of mpox and prevent future outbreaks.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss what’s new and ongoing with pathogens and infections.Their discussion includes:Summer cases of COVID-19.H5N1 (avian influenza) activity and testing options.Increasing dengue fever infections.Outbreaks of listeria and cyclospora.The importance of public-private partnerships in preventing disease outbreaks and increasing access to testing.

Maria Alice Willrich, Ph.D., and Melissa Snyder, Ph.D., explain how Mayo Clinic Laboratories' unique risankizumab panel measures levels of both that drug and its antibodies in patients' blood. The results can better guide the management of patients with inflammatory bowel disease.Speaker 4: (00:32) Please give the audience a little information about yourself and your background. Speaker 4: (02:12) Please give the audience a brief overview of this assay. Speaker 4: (04:34) Which patients should have this testing and when should it be performed? Speaker 4: (05:50) What alternative testing options are available and how do these compare? Speaker 4: (06:47) How are the results used in patient care?

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss insights from Dr. Morice’s recent travels abroad, including biomanufacturing, diagnostics, cybersecurity, and supply chain activities.Their discussion includes:What’s happening in the global diagnostics industry and takeaways from visiting Saudi Arabia and Italy.Why countries are looking toward building their own biomanufacturing and diagnostic resources, and the impacts of a global supply chain.The evolution of digitalization and cybersecurity.

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 Elitza Theel, Ph.D., director of the Infectious Diseases Serology Laboratory at Mayo Clinic, to discuss the increase of dengue cases in the United States and around the world.Specific topics of discussion include:The characteristics and symptoms of dengue virus.Current dengue activity in the United States, why cases are increasing, and how it may impact public health.Whether an individual infected with dengue has future immunity against the virus.Laboratory tests used to detect and diagnose dengue.How to protect against dengue and other vector-borne diseases.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss how healthcare is a logical space to apply artificial intelligence (AI) technology and trends in how AI is being utilized.Their discussion includes:The benefits and pitfalls of using AI in clinical settings.Important factors to consider before implementing AI tools in the laboratory.A successful AI use case from the Parasitology Lab at Mayo Clinic, and how it enhanced turnaround times and staff satisfaction.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss a case that was recently overturned by the Supreme Court of the United States that may have ramifications for the healthcare industry, including impacts on regulatory oversight.Their discussion includes:A summary of the Supreme Court ruling on June 28 to overturn the 1984 Chevron v. Natural Resources Defense Council decision, and how that impacts the power of federal agencies and the interpretations of the laws they administer. How this decision may impact current healthcare issues like reimbursement and the U.S. Food and Drug Administration’s (FDA) final rule on regulating laboratory-developed tests as medical devices.The ambiguity of what comes next, and the importance of engaging members of Congress on these important decisions.

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 Paul Jannetto, Ph.D., director of the Metals Laboratory at Mayo Clinic, and Sarah Erdahl, technical specialist coordinator in the Metals Laboratory. They discuss their unique opportunity to complete testing on locks of hair from the composer Ludwig von Beethoven.Specific topics of discussion include:How Mayo Clinic came to be involved in the project, and what historians were hoping to learn from the test results.The technical process of preparing, handling, and testing Beethoven’s hair.What the test results revealed about Beethoven’s health.An overview of Mayo Clinic’s Metals Laboratory and the specialized testing that occurs in the lab.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the summertime activity of COVID-19 and the latest updates with avian influenza (H5N1).Their discussion includes:The recent rise in COVID cases and how the new FLiRT variants of the virus are affecting the immune system.Updates on avian influenza activity and the risk for more mutations and human infections.How the U.S. Centers for Disease Control and Prevention (CDC) is responding to the avian flu outbreaks and how laboratories are preparing to support testing needs.Reminders of how to best protect yourself and your loved ones from infectious diseases this summer.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss the platform business model and how it’s being used in the healthcare industry to drive innovation and reimagine how care is provided.Their discussion includes:Key takeaways from the recent conference hosted by Mayo Clinic Platform.What constitutes a platform and how the model is being implemented in the healthcare industry.How the platform model can transform the way healthcare is delivered, and the implications this transformation has on laboratory medicine and pathology.

Anastasia Zekeridou, M.D., Ph.D., explains how Mayo Clinic Laboratories' updated panels and methodology boost the accuracy and efficiency of testing for three autoimmune neurology biomarkers. Early diagnosis is key to managing debilitating conditions associated with these antibodies.(00:32) Could you please give our listeners an overview of your role at Mayo Clinic? (01:22) What updates are happening in our laboratory to increase specificity when we receive a patient's serum and CSF for most of the CNS evaluations? (03:48) Why are these updates and additions important in the larger disease state?(06:16) Could you expound upon the relationship between the clinical practice and the lab? (08:32) What do these changes mean for patient care? (10:27) What about the inclusion of AMPA in the pediatric evaluation, and the inclusion of IgLON5 with autoimmune axonal? (12:58) How does your lab discern when it's time to add a biomarker? (15:44) What are you most excited about?

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss why measles remains a virus of concern, how avian flu continues to spread, and new developments in the federal regulation of laboratory-developed tests.Their discussion includes:How a person infected with measles recently traveled through a U.S. airport, and the severity of the measles virus.The continued deadly spread of avian flu among wild birds, domestic poultry, and cattle, and the infection of a third human.Avian flu vaccine development and the importance of emergency preparedness.The American Clinical Laboratory Association’s (ACLA) lawsuit against the U.S. Food and Drug Administration (FDA) regarding the agency’s final rule to treat laboratory-developed tests as medical devices.

Divyanshu Dubey, M.B.B.S., explains how Mayo Clinic Laboratories' unique PDE10A and TRIM46 assays facilitate care for central nervous system disorders triggered by cancer. Early diagnosis and treatment are important for managing disabling neurological symptoms and malignancy.(00:32) Could you tell us a bit about your background and your role at Mayo Clinic? (01:26) How do the tests that are coming live relate to the larger disease state of neurological disorders? (02:44) Can you share a little bit about the methodology we're using for these particular biomarkers? (05:15) How was PDE10A discovered? (06:48) Anything you would add? (07:50) Remind us which phenotype-specific assays these biomarkers are being added to, and how physicians should determine whether this testing is appropriate? (09:55) What does early detection of these biomarkers mean for the patient's prognosis, diagnosis, treatment, etc.? (12:33) What are you most excited about with the launch of these 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 Peter Lucas, M.D., Ph.D., vice chair of Research for the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic. Their discussion includes: Dr. Lucas’ extensive pathology and research background and his journey to Mayo Clinic. His goals for expanding DLMP’s research activities and advancing innovation in diagnostics.How laboratory research has evolved over his career and how researchers can continue to make progress despite obstacles.The importance of having good mentors, collaborating with others, staying curious, and remaining persistent to achieve goals.

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 Matthew Binnicker, Ph.D., professor of laboratory medicine and pathology and clinical virologist at Mayo Clinic. They discuss the widespread outbreaks of H5N1 bird flu and the new “FLiRT” variants of COVID-19.Specific topics of discussion include:The current situation of avian flu activity across the world and throughout the United States, including outbreaks in poultry, U.S. dairy cows, and one recent human case.How this outbreak is different than previous ones, and the current public health risk.Resources for testing humans for avian flu.What we know about the new “FLiRT” variants of COVID-19 and how they might impact public health in the months ahead.

Robert Jenkins, M.D., Ph.D., Stephanie Smoley, CG(ASCP), and Beth Pitel, M.S., explain how Mayo Clinic Laboratories' augmented MayoComplete Solid Tumor Panel better profiles tumor genetics. Defining tumor pathogenesis can guide targeted cancer therapy. (00:31) Can you tell us a little about yourself and your background — Beth? (01:24) Stephanie, what about you? (01:42) Dr. Jenkins, a little bit about yourself and your background, please? (02:25) Could you provide a brief overview of the new MayoComplete Solid Tumor assay and the enhancements we've provided?(04:02) What changes did you incorporate into the test? (04:57) Why are copy number variants and loss of heterozygosity important, and how are they used in patient care? (07:12) Does including these genes guide patient care in a more valuable way? (07:51) What alternative test options are available and how do they compare to the MayoComplete Solid Tumor Panel? (10:27) Is having many options available in a one-stop shop important to help guide patient management? (11:57) Do you have anything else you'd like to add about the MCSTP enhancements and what the new test assay will deliver in terms of clinical utility or patient care?

Rapidly progressive dementia covers many conditions, including Creutzfeldt-Jacob disease (CJD). Gregory (Gregg) Day, M.D., explains how Mayo Clinic Laboratories' new evaluations help identify the cause of rapidly progressive dementia, to guide prognosis and treatment decisions.Show notesSpeaker 3: (00:32) Can you provide a little background about your role here at Mayo Clinic and experience with this disease state? Speaker 3: (01:21) Can you give us an understanding of rapidly progressive dementia? How is it different and what should physicians be looking for? Speaker 3: (03:13) You mentioned "syndromic" and that there are several diseases underneath that, one of them being Creutzfeldt-Jacob. Can you explain the others in a bit more detail? What makes them each unique under the heading of rapidly progressive dementias? Speaker 3: (05:29) Does that encompass it: prion diseases, then the neurodegenerative bucket, then autoimmune? Speaker 3: (06:03) Can you speak to the components of the new Creutzfeldt-Jacob disease-specific evaluation and the rapidly progressive dementia evaluation, and the assays that they're performed on? Speaker 3: (09:30) Anything you want to add to that summary of the assays' components? Speaker 3: (11:09) Can you explain the role — or lack thereof — of the 14-3-3 protein biomarker, according to our research? Speaker 3: (13:44) Which patients should get this testing, and who should not? Speaker 3: (17:22) What does it mean if the results come back positive and if the results come back negative? Speaker 3: (21:57) What are you most excited about with these 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 Eric Hsi, M.D., chair of the Department of Laboratory Medicine and Pathology at Mayo Clinic. Their discussion includes:Dr. Hsi’s experience in the field of pathology and what he is looking forward to working on as the new chair of the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic.Some common challenges facing laboratory professionals today and ways to overcome them.Advancements and trends in pathology and staying current with new developments.Words of advice for pathologists who are beginning their careers.

Paul Jannetto, Ph.D., explains the advantages that Mayo Clinic Laboratories' oral fluid drug screening offers over typical urine tests. Oral samples are easier to collect and harder to adulterate.(00:32) Can you tell us a little bit about yourself and your background? (01:46) Can you please provide an overview of laboratory testing for substance use disorders and specifically Mayo Clinic's new oral fluid controlled substance monitoring option? (03:47) Which patients should have this testing and when should it be performed? (05:16) What alternative test options are available and how do these compare? (06:31) How are the results used in patient care?

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?

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss testing innovations for Alzheimer’s disease and cognitive impairments, and how laboratorians can responsibly help shape the future of healthcare.Their discussion includes:The latest news about the U.S. Food and Drug Administration’s (FDA) proposed rule around regulating lab-developed tests.New testing innovations for Alzheimer’s disease and cognitive impairments, including Mayo Clinic Laboratories’ plasma biomarker testing for Alzheimer’s disease. The importance of being responsible lab stewards and working closely with clinicians to understand how different testing approaches drive decision-making in healthcare settings.

Maryam Shahi, M.D., explains how Mayo Clinic Laboratories' unique biomarker test (TEST ID: AFOLR) determines which patients would likely benefit from a new treatment for recurrent epithelial ovarian cancer. Disease recurrence is common, and about one-third of patients respond to the new medication. (00:32) Could you provide us with a little bit of information about yourself and your background? (01:18) Can you start with a brief overview of the assay? (02:13) Which patients should have this testing and when should it be performed? (03:21) Are there alternative test options available and how do those compare with the folate receptor alpha assay? (03:57) How are the results used in patient care?

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss current events including Medical Laboratory Professionals Week, recent healthcare conferences, advocacy efforts, measles, and bird flu.Their discussion includes:Key takeaways from the Becker’s Healthcare Annual Meeting and the College of American Pathologists’ (CAP) Pathologists Leadership Summit.The resurgence of measles cases and recent activity of bird flu (H5N1).Tips for staying engaged and being the voice for patients.

Maria Alice Willrich, Ph.D., explains how Mayo Clinic Laboratories' new assay provides therapeutic drug monitoring of risankizumab, or RISA. Test results help guide care for patients with plaque psoriasis, psoriatic arthritis, and Crohn's disease.(00:32) Do you mind giving the audience more information about yourself and your background? (01:53) Could you please give a brief overview of this assay? (03:35) Which patients should have this testing and when should it be performed? (04:57) How are the results used in patient care? (06:59) Other monoclonal antibody therapies are usually monitored by a combination of drug quantification and analysis of antidrug antibodies. How is this test being offered?

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 Elitza Theel, Ph.D., director of the Infectious Diseases Serology Laboratory at Mayo Clinic, to discuss tick-borne diseases and the latest testing options.Specific topics of discussion include:The types of tick-borne diseases found throughout the United States. Algorithmic approaches and testing methods used to diagnose tick-borne diseases.Helpful resources for clinicians, including Mayo Clinic Laboratories’ Acute Tickborne Disease Testing Algorithm and Lyme Neuroborreliosis Diagnostic Algorithm.New tests recently developed by Mayo Clinic Laboratories to aid in the diagnosis of tick-borne disease, including:A broad range bacterial PCR and sequencing test for tick-borne bacteria and some zoonotic bacterial pathogens that may have a similar presentation (Mayo ID: BRBST).Molecular PCR testing to detect the viral RNA of Heartland virus in spinal fluid (Mayo ID: HRTVC) and serum (Mayo ID: HRTVS).Preventing tick bites.

Alicia Algeciras-Schimnich, Ph.D., discusses how Mayo Clinic Laboratories’ new noninvasive blood test for Alzheimer’s disease identifies the p-tau217 biomarker, which is associated with the accumulation of amyloid beta in the brain. Positive test results can facilitate access to disease-modifying therapies. (00:32):Dr. Algeciras, could you just provide a little bit of background on your role at Mayo Clinic?(01:45):So before we get into the test itself, can you just explain a little bit about the disease state and especially some of the recent changes? (07:39) So can you explain a little bit more about what the results that our clients will receive look like? (10:30) Can you just give a quick overview of how our test is unique compared to those on the market? (12:24) What patients should have this testing performed, Dr. Algeciras and if you have any tips on which patients should not, please include that as well? (14:42) Let's talk now about how those results are used in patient care. (16:31) One more question, just summarize for our listeners what you're most excited about with this new test.

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss current events including dengue outbreaks, new colon cancer screening technology, and insurance coverage of innovative lab tests.Their discussion includes:The surge of dengue cases in Latin America, and best practices for tick and mosquito bite prevention.Advancements in laboratory tests and technology used for colon cancer screening.Issues with insurers paying for new screening technology versus routine screening methods.How laboratorians can help educate physicians and policymakers on how innovative laboratory tests create value for patients and the entire healthcare system.

Bobbi Pritt, M.D., explains how Mayo Clinic Laboratories' new assay identifies less-common tick-borne bacteria in whole blood. The assay is recommended when tick-borne bacterial infection is suspected but standard testing is unrevealing.(00:33) Do you mind giving us a brief introduction of yourself and what you do at Mayo? (01:45) Can you tell us a little about the test and how it came to be? (03:00) Could you explain the types of patients this test would be best suited for and how a provider might determine if their patient would benefit from this? (03:32) Would you please explain why the algorithm is recommended and where in the algorithm this test fits? (04:36) What makes this test different from what's currently available to providers? (05:38) How can the information be used in patient care? And can you talk a little bit about how the diagnosis can be clarified by using this assay, why it's important, and how the results would impact a patient's care and treatment plan?

The Centers for Disease Control and Prevention (CDC) issued a recent health advisory in response to the increasing number of measles outbreaks in the United States.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 Matthew Binnicker, Ph.D., professor of laboratory medicine and pathology and clinical virologist at Mayo Clinic, to discuss why measles is in the news again and how we can prevent measles outbreaks.Specific topics of discussion include:The symptoms, characteristics, and complications of the measles virus.The recent rise in measles cases and outbreaks being reported across the United States.The importance of vaccination in preventing the spread of the highly contagious virus.Why the measles laboratory test was eventually developed, and testing options available through Mayo Clinic Laboratories.

Linda Hasadsri, M.D., Ph.D., and Huong T. Cabral, M.S., C.G.C., explain how Mayo Clinic Laboratories' targeted test panel facilitates accurate diagnosis of hereditary pancreatitis, which heightens the risk for pancreatic cancer. Test results can guide cancer monitoring for patients and their families.(00:33) Dr. Hasadsri, can you tell the audience a little bit about yourself and your background? (01:32) And Ms. Cabral? (02:03) Can you please give the audience a brief overview of this assay? (03:33) Which patients should have this testing and when should it be performed? (04:23) What alternative test options are available and how do these compare to our hereditary pancreatitis test? (08:48) How are results used in patient care?

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 William Morice II, M.D., Ph.D., CEO and president of Mayo Clinic Laboratories. They discuss important industry updates and legislative insights gathered from Dr. Morice’s recent trip to Washington, D.C.Their discussion includes:The status of current laboratory-related legislative efforts, including the Protecting Access to Medicare Act (PAMA), the Saving Access to Laboratory Services Act (SALSA), and the Pandemic and All Hazards Preparedness Act (PAHPA).Current issues facing the laboratory industry, including prior authorization, coding, and potential FDA oversight of laboratory-developed tests.The importance of advocating on behalf of laboratories, clinicians, and patients, and engagement opportunities through professional societies like the College of American Pathologists and the American Clinical Laboratory Association.

Wei Shen, Ph.D., and Rhianna Urban, M.S., CGC, explain how Mayo Clinic Laboratories' gene panel establishes a diagnosis of Lynch syndrome, which heightens the risk for several cancers. Test results can guide cancer surveillance for patients and their families.(00:32) Would each of you share a little bit about yourselves and your background? Dr. Shen? (01:25) Rihanna, could we have you give a little background about yourself as well? (01:48) Could you provide us with an overview of Lynch syndrome? (03:44) Can you expand on why genetic testing for Lynch syndrome is so important? (06:03) Who would benefit from Lynch testing? (07:51) Is Lynch syndrome the only type of inherited predisposition to colon cancer? (08:48) Does the healthcare provider order these tests, and what kind of samples should be considered in these patients? (10:50) Are there any limitations to the types of variants that can be detected by this test? And how does Mayo Clinic Laboratories ensure comprehensive results for patients?(14:24) How are the results used in patient care? (16:33) Could you summarize the benefits of these tests and of doing them at Mayo Clinic Laboratories?

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 Elitza Theel, Ph.D., director of the Infectious Diseases Serology Laboratory at Mayo Clinic, to follow up on the syphilis epidemic and discuss updated testing recommendations.Specific topics of discussion include:Background information on syphilis and the epidemic occurring in the United States.The report recently published by the Centers for Disease Control and Prevention (CDC) with updated laboratory recommendations for syphilis testing.The different testing methods used to diagnose syphilis.

Paul Jannetto, Ph.D., explains how Mayo Clinic Laboratories' nicotine testing benefits patients in substance-use cessation programs and other settings. The serum and urine tests quantify nicotine and various metabolites.(00:32) Can you tell us a little bit about yourself and your background? (01:42) Can you please provide an overview of substance use disorders, specifically nicotine dependence, and Mayo Clinic's nicotine testing options? (04:33) Which patients should have this testing and when should it be performed? (05:54) What alternative test options are available and how do these compare?(06:40) How are the results used in patient care?