Shows
LabMindAnswering Your Questions About the FDA’s Final Rule on LDTsAs 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.
2024-09-1143 min
LabMindAn Interview With Dr. Jonathan Genzen: Answering Your Questions About the FDA’s Final Rule on LDTsAs 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://yo...
2024-09-1143 minLabMindAn Interview With Drs. Meghan Delaney and Eric Konnick: How FDA Restrictions on Laboratory-Developed Tests Will Harm Patients and Increase CostsThe FDA recently announced a plan to regulate laboratory-developed tests (LDTs) as medical devices. In this interview, Dr. Meghan Delaney from Children’s National Hospital and Dr. Eric Konnick from the University of Washington explain why many tests that are critical to patient care, particularly in the areas of pediatrics, transplantation, and rare diseases, may become unavailable if the rule the FDA has proposed is enacted. Other tests may remain available, but at a significantly increased cost. Dr. Jonathan Genzen, ARUP’s chief medical officer and cohost of this episode, describes how laboratory professionals can provide public feedback to the...
2023-11-0641 minLabMindHow FDA Restrictions on Laboratory-Developed Tests Will Harm Patients and Increase CostsThe FDA recently announced a plan to regulate laboratory-developed tests (LDTs) as medical devices. In this interview, Dr. Meghan Delaney from Children’s National Hospital and Dr. Eric Konnick from the University of Washington explain why many tests that are critical to patient care, particularly in the areas of pediatrics, transplantation, and rare diseases, are likely to become unavailable as a result. Other tests may remain available, but at a significantly increased cost and/or lower quality. Dr. Jonathan Genzen, ARUP’s chief medical officer and cohost of this episode, describes how laboratory professionals can provide public feedback to the FDA...
2023-11-0641 min
Inside the LabS4Ep2: The FDA’s Proposed Rule on Laboratory Developed TestsTests that are designed in-house to fulfill a clinical need (but aren’t FDA approved) qualify as laboratory developed tests. And these LDTs are currently regulated by CLIA. But the FDA is proposing a new rule that would give them oversight of the design and development of laboratory developed tests. So, what does that mean for us? How would this new legislation impact everyday practice inside the lab? On this episode of the podcast, your hosts, Ms. Kelly Swails, MLS(ASCP), and Dr. Ali Brown, MD, FASCP, are joined by Dr. Gregory Sossaman, MD, Clinical Pathologist and Ser...
2023-10-2042 minInside the LabS3Ep7: Everything You Need to Know About RISEASCP’s Resident In-Service Exam, better known as RISE, began in 1983, and it was designed as a study tool for board exams. But RISE has evolved over time in response to feedback from program directors and residents alike, adapting to remain relevant to practice and help students identify their individual strengths and weaknesses. So, what do you need to know about the Resident In-Service Exam and how it can ensure your success as an emerging pathologist or laboratory professional? On this episode of Inside the Lab, your hosts Dr. Ali Brown, MD, FASCP, and M...
2023-02-1438 min