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, September 23, 2026. 12 PM-1 PM ET
Roundtable presenters Dr. David Sacks MB, ChB, FRCPath, Chairman, Steering Committee National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience
CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Tosoh Bioscience Inc.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, September 24, 2026 11 AM-12 PM CT
This session explores the evolving role of RAS in precision oncology, from the biology of RAS mutations to the expanding landscape of targeted therapies. Through expert presentations, real-world case discussions, and interactive audience polling, participants will examine best practices for RAS biomarker testing across solid tumors, including lung, colorectal, and pancreatic cancers. The session will highlight practical considerations for tissue and liquid biopsy, strategies to address testing gaps, and the importance of multidisciplinary collaboration to ensure timely identification of patients who may benefit from RAS-targeted therapies.
Webinar presenters David Braxton, MD, Chief of Molecular Pathology Services, Hoag Family Cancer Institute & Hoag Memorial Hospital Presbyterian, and Carlos Becerra, MD, Research Director for Medical Oncology, Margaret Given Larkin Endowed Chair for Developmental Cancer Therapeutics, Hoag Memorial Hospital Presbyterian
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from OncoLens and Diaceutics.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center
CAP TODAY does not endorse any of the products or services named within. The roundtable is made possible by a special educational grant from Pillar Biosciences.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, October 1, 2026 1 PM-2 PM ET
This presentation will explore the value of in-house CGP, offer insights into the benefits and drawbacks of incorporation, and provide information about important practical factors when considering in-house implementation of CGP.
Webinar presenter Allison M. Cushman-Vokoun, MD, PhD, FCAP, Medical Director, Molecular Diagnostics and Personalized Medicine Laboratory, Director, Division of Diagnostic Molecular Pathology and Human Genetics, Henry F. Krous Professor of Pathology, University of Nebraska Medical Center
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Illumina.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, October 20, 2026 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.
Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology, Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Roche.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, November 3, 2026 1 PM-2 PM ET
Hear an expert discuss the challenges of detecting NRG1 fusions and how RNA-based testing can support more comprehensive fusion identification in clinical practice.
Webinar presenter Benjamin Weinberg, MD, Associate Professor of Medicine and Attending Physician
specializing in gastrointestinal medical oncology
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Diaceutics.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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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.