Every specimen represents a potential mystery, and laboratory professionals often play the role of detectives. For the 2025 Lab Week episode of LabMind, Amanda Openshaw, a genetic counselor at ARUP, shares examples illustrating the importance of good investigative work in the laboratory to discover accurate diagnoses.

Why hasn’t there been more progress in developing therapies for Alzheimer’s disease and related forms of dementia? One reason has been the lack of specific laboratory tests that can properly diagnose and characterize these diseases. In this interview, Dr. Qinwen Mao from the University of Utah describes how her research team is helping to bring new blood and cerebrospinal fluid biomarkers into clinical practice to step up the fight against these devastating diseases.

Related Information: Webinar: Innovations in Diagnostics for Alzheimer’s Disease and Related Dementias (aruplab.com/AlzInnovations)

As laboratory professionals, we may think we have a good understanding of how physicians use our services. But how often do we ask them for practical feedback? In this interview, family physician Dr. Keith Elkins shares his perspectives on what clinical laboratories and pathologists do well, and what opportunities they may be overlooking to better support frontline clinical care.

Many people in the healthcare profession know that clinical laboratories are under more rigorous regulatory scrutiny than just about any other area of medicine. What they may not know is that the New York State Department of Health (NY DOH) was the pioneer in laboratory regulation, starting long before the implementation of either the FDA Medical Device Amendments or the Clinical Laboratory Improvement Amendments (CLIA) of 1988. In this interview, Beverly Rauch, MS, director of the NY DOH’s Clinical Laboratory Evaluation Program (NY CLEP), describes its process for granting permits, inspecting laboratories, and approving assays, and what the new FDA LDT rule might mean for the program.

In this age of ChatGPT, artificial intelligence (AI), and machine learning, laboratory professionals might think they need to be experts in sophisticated new technology to glean insights from laboratory data. But as ARUP’s medical director of operational informatics Dr. Jenna Rychert points out in this interview, data analysis doesn’t always have to be complicated to provide meaningful value.
Related Information: Laboratory-Developed Tests Account for a Small Minority of Tests Ordered in an Academic Hospital System [hyperlinked to: https://pubmed.ncbi.nlm.nih.gov/37265129/

Anatomic pathology is on the verge of its biggest technologic shift in over a century. Making a smooth transition will require leadership to pay as much attention to the human impact as to the technology itself. In this discussion, Dr. Suzanne Dintzis from the University of Washington explains why hospital and department leaders will need to partner with front-line laboratory professionals and pathologists who perform the day-to-day work.

As of September 2024, there remains enormous uncertainty about the FDA’s final rule on laboratory-developed tests (LDTs). Will it hold up in court? Which tests are subject to which requirements? How can laboratories best prepare? In this interview, Dr. Jonathan Genzen, ARUP’s chief medical officer and senior director of governmental affairs, responds to questions sent in by members of the laboratory community.

Related Information:

• ARUP Resources on the FDA’s Final Rule on Laboratory-Developed Tests (https://www.aruplab.com/fda-ldt-final-rule)
• ARUP Webinar--The FDA’s Final Rule on LDTs: What You Need To Know (https://youtu.be/nGQ3sRfWkBg)
• ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests (https://www.aruplab.com/news/05-30-2024/arup-files-declaration-support-lawsuit-challenging-fdas-rule)
• FDA email address for questions on the final rule: (ldtfinalrule@fda.hhs.gov)

Fixing American healthcare will require more than mere tweaks around the edges. Dr. Vikas Saini, president of the Boston-based Lown Institute, believes that it will require a return to medicine’s humanist roots. In this interview he describes some of the ways in which many healthcare organizations prioritize revenue and profit over patients and communities. He also explains why he remains optimistic that Hippocratic principles will ultimately prevail.

Related Information:

• Lown Institute (https://lowninstitute.org/)
• 2024 Top Hospitals: America’s Most Socially Responsible Hospitals (https://lownhospitalsindex.org/the-most-socially-responsible-hospitals-in-the-u-s-2024/)
• 2023 Shkreli Awards: The Lown Institute’s Top Ten List of the Worst Examples of Profiteering and Dysfunction in Healthcare (https://lowninstitute.org/projects/2023-shkreli-awards/)