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 Commercial Conversations — Register Now
Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
assessments for solid tumors in the absence of a companion diagnostic.
Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, November 18, 2026, 12:00 PM-1 PM ET
Join leading pathology experts, Savitri Krishnamurthy, MD, and Marilyn Bui, MD, PhD, for a webinar exploring potential challenges in HER2 IHC testing for breast cancer, emerging evidence supporting digital and computational pathology as assistive tools for pathologists in HER2 IHC assessment, and practical considerations for real-world implementation and adoption.
Webinar presenters Savitri Krishnamurthy, MD, Professor of Pathology, Department of Anatomical Pathology The University of Texas MD Anderson Cancer Center, Houston, Texas, and Marilyn Bui, MD, PhD, Surgical Pathologist and Cytopathologist Member and Professor, Departments of Pathology, Machine Learning, and Translational Pathology, Scientific Director, Analytic Microscopy Core Chair, Women in Oncology Executive Board Moffitt Cancer Center, Tampa, Florida
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speakers are being compensated for their presentations. The program is not CME accredited and may not be used for CME credit.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, December 9, 2026, 12 PM-1 PM ET
Hear an expert pathologist discuss the role of HER2 IHC testing and scoring in solid tumors including endometrial, ovarian, cervical, bladder, non-small cell lung, colorectal, and biliary cancers
Webinar presenter Michelle Shiller, DO, MSPT, Baylor Sammons Cancer Center; Fulgent Genetics; Texas Cancer Interception Institute
CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
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.