Q&A column
May 2024
Q. I know that CLIA is changing and more tests/analytes will become CMS regulated, along with other changes. Can you provide some background and an overview of the changes and when they will become effective? Read answer.
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
Subspecialties
Interactive Product Guides
2024 issues
Newsbytes
May 2024—The FDA has granted marketing authorization, through the de novo pathway, for Prenosis’ Sepsis ImmunoScore artificial intelligence-enabled software as a medical device, or SaMD, for the rapid diagnosis and prediction of sepsis.
Put It on the Board
May 2024—Risant Health has completed its acquisition of Geisinger as its first health system dedicated to increasing access to value-based care and coverage. Risant says the organizations together will create a new value-based care platform that includes best practices, tools, technology, and services to support community-based health systems.
Hybrid practice model beckons as solution
With the technology now available, could and should remote diagnostic pathology, or at least a hybrid model, become more the norm in the future? Timothy Craig Allen, MD, JD, and Casey P. Schukow …
Need for speed in solid tumor molecular testing
April 2024—As the call for fast turnaround of genetic testing results in tumor profiling grows louder, the need for rapid, reliable test methods becomes more pressing. Meanwhile, with new genetic biomarkers emerging at a rapid pace, “everything has tipped the balance toward comprehensive next-generation sequencing analysis,” said Maria E. Arcila, MD, attending pathologist, molecular diagnostics and hematopathology services, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center. In the midst of this complexity, “the ability to provide rapid and simple results is lagging behind,” said Dr. Arcila, in addressing rapid molecular testing in solid tumors at the Association for Molecular Pathology meeting last year.
Microscope to image—big lift but also a blueprint
April 2024—The Food and Drug Administration in February cleared Proscia’s Concentriq AP-Dx digital pathology software for the purpose of primary diagnosis. Shortly after, Proscia cofounder and CEO David West spoke with CAP TODAY publisher Bob McGonnagle about achieving new efficiencies, elevating pathology, the heterogeneous nature of the pathology community, and being able to learn from digital pathology’s early adopters. “Laboratories and pathologists going digital don’t have to be first anymore,” West said.
Billing headwinds grow stronger for labs
April 2024—In billing for pathology and laboratory services, the hurdles are only getting higher. Narrow networks, prior authorizations, claims denials. Payers “have deeper pockets and figure they can outlast us,” said Joe Saad, MD, chair of the CAP Council on Government and Professional Affairs, in a Feb. 14 roundtable led online by CAP TODAY publisher Bob McGonnagle. He and others talked about AI, digital pathology codes and molecular Z-Codes, biomarker testing, and unity within the laboratory community.
How Duke’s molecular diagnostics lab retains and trains
April 2024—Too few people, too much to do. In that, Duke Health’s molecular diagnostics laboratory is no different from any other laboratory. But competing for staff on the basis of money alone is out. “The reality is that in today’s labor market, any molecular technologist can always find a job that pays more,” says Barbara Anderson, PhD, MB(ASCP)CM, analytical specialist in Duke’s molecular diagnostics laboratory, Division of Molecular Pathology, Genetics, and Genomics.
AMP case report: Use of molecular techniques to solve a challenging case of primary cutaneous marginal zone lymphoma
April 2024—Primary cutaneous marginal zone lymphoma (PCMZL) is a newly recognized, distinctive subtype of non-Hodgkin’s lymphoma. This low-grade lymphoma predominantly presents as papules or nodules within the skin of middle-aged adults. Formerly grouped under the extranodal marginal zone lymphoma (EMZL) category, the World Health Organization’s fifth edition classification of hematolymphoid tumors now recognizes PCMZL as a distinct entity.
A how-to guide to quality management in clinical labs
CAP Publications released this month its newest book, Quality Management in Clinical Laboratories: Optimizing Patient Care Through Continuous Quality Improvement. It is a second edition; the first was published in 2005. Twenty-one contributors cover everything from laboratory staff and informatics to all phases of testing and the laboratory quality management plan.