Where court’s LDT decision leaves labs
September 2025—The Food and Drug Administration’s efforts to regulate laboratory-developed tests as medical devices came to a decisive halt this spring with a ruling from the U.S. District Court …
Webinars and Sponsored Roundtables — Register Now
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenter Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, July 15, 2026, 1:00-2:00 PM ET
Hear an expert discuss how to integrate Kappa and Lambda in situ hybridization testing into your standard hematopathology workflow to accurately assess B-cell and plasma cell clonality. You will also gain the skills to recognize testing pitfalls in challenging reactive versus neoplastic proliferations and apply ancillary tools to resolve complex cases.
Webinar presenter Xiaojun Wu, MD, PhD, Assistant professor, Director of Hematopathology Section at NCR of Johns Hopkins Medicine Department of Pathology, SOM at Johns Hopkins University
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, July 21, 2026, 11:00-11:30 AM CT
Learning Objectives:
- Explain how transparency and manufacturer partnerships improve quality, consistency, and decision-making confidence in specimen management.
- Evaluate blood collection tubes beyond cost and commodity assumptions, incorporating clinical impact and risk into decision-making.
- Assess the potential risk points when using a blood collection device that has not been cleared for a specific purpose.
Roundtable presenters Nick Fingland, PhD, PMP, Senior Director, R&D Operations and Science, BD, and Chris Farnsworth, PhD, D(ABCC), Section Head of Clinical Chemistry, Professor of Pathology and Immunology, Washington University School of Medicine.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
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Publisher’s Pick
Big interest, gaps in early pancancer testing
August 2025—There’s the cart before the horse. There are certain equines that should not be flogged; others should not be backed. There’s closing the stable door at an unfortunate time.
Too few phlebotomists—is Aletta the answer?
July 2025—It was one of those infamous winter days in Chicago. The phlebotomy staff were calling off work, and Gregory S. Retzinger, MD, PhD, had reached his breaking point. Phlebotomists tend to be in short supply, and Northwestern Memorial Hospital, where Dr. Retzinger is medical director of pathology clinical services, is no exception.
Tumor marker testing in body fluids calls for caution
June 2025—With few FDA-cleared or -approved methods for tumor marker testing in body fluids, it is the laboratory that’s responsible for the tests. “A specimen arrives at your door, and you have to figure out what, if anything, you’re going to do,” said Jonathan Genzen, MD, PhD, MBA.
Taking on low, ultralow HER2 breast cancer
May 2025—Since the hunt began to identify low levels of HER2 in metastatic breast cancers, the action has revealed itself like the plot of a Henry James novel: Nothing much happens. Also, a lot happens. And each narrative thread is conveyed in hard-to-parse language. The goal has been to qualify patients for the antibody-drug conjugate trastuzumab deruxtecan (T-DXd), which was shown in the Destiny-Breast04 trial to significantly improve survival in so-called HER2-low cases. Immunohistochemistry assays were designed to identify strongly positive cases, however, and thus not useful for those at the 0 and 1+ end of the spectrum. Now, several years after the presentation of the D-B04 results at the ASCO 2022 annual meeting, which launched the low-end ship, pathologists and oncologists are adjusting to the implications of the most recent Destiny trial, D-B06. In late January, the FDA approved the drug Enhertu for HER2-low or HER2-ultralow cases, as well as the Ventana Pathway HER2 (4B5) companion diagnostic for assessing these lower levels of HER2 in patients with metastatic breast cancer.
For myeloid malignancies, how WHO-HEM5 and ICC differ
May 2025—How the World Health Organization fifth edition of hematolymphoid tumors and the International Consensus Classification differ for myeloid malignancies was highlighted in cases presented in a CAP24 session last fall. Sanam Loghavi, MD, associate professor of pathology and laboratory medicine, Department of Hematopathology, University of Texas MD Anderson Cancer Center, spoke of myelodysplastic neoplasms/syndromes (MDS) with defining genetic abnormalities and the allelic state of TP53 in MDS, among other things. (Kamran M. Mirza, MD, PhD, of the University of Michigan, co-presented.)
Not to be overlooked: lab administrative skill
April 2025—The transition from pathology training to practice is not just about diagnostic skill and confidence in that skill but also laboratory administrative duties, with experience in the latter harder to gain as a trainee.