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 …
Thursday, August 20, 2026. 12 PM-1:30 PM ET
Hear from an expert in HER2 IHC whose work has contributed to current scoring guidelines.
Webinar presenter Josef Ruschoff, MD, PhD, Former Chief Medical Officer and Co-Founder of Targos, Senior Consultant of Discovery Life Sciences, Kassel, Germany.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
To be rescheduled to a future date
Learn about digital pathology technology that is future-ready, yet practical for today’s
laboratory needs.
Webinar presenters Scott Hammond, Senior Systems Consultant, Digital Pathology Division, Wexner Medical Center, Department of Pathology, and Ursula Hofer, Imaging Technologist, Pathology Digital Imaging Lab, Wexner Medical Center, Department of Pathology, and Sandra Banky, PA(ASCP), Director of Operations, Wexner Medical Center, Department of Pathology.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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 …
September 2025—Angela Vetch, MPH, DLM(ASCP), is tired of reading about large commercial labs buying hospital laboratories’ outreach business. “There is an alternative to that story,” said Vetch, director of laboratory services at Kootenai Health, a three-hospital system in Coeur d’Alene, Idaho.
September 2025—Avian influenza, self-collection, and diagnostic stewardship in the microbiology laboratory are three topics of many that can be explored at the Association for Molecular Pathology meeting in Boston this November. Andrew Pekosz, PhD, heads a research laboratory at Johns Hopkins University that studies the replication and disease potential of emerging respiratory viruses.
September 2025—The largest repository of pathology slides and tissue blocks is becoming a powerful data repository with the promise to transform diagnosis and treatment through the use of artificial intelligence.
September 2025—A 68-year-old male with a history of multiple myeloma was discovered to have a 3-cm carotid body mass on PET/CT. Surgery was consulted and determined that the lesion was not amenable to surgery. Radiology favored the lesion to be a paraganglioma, so plasma metanephrine and normetanephrine were tested and were negative. With paraganglioma as the working diagnosis, germline genetic testing was performed.
September 2025—In a CAP session last year on timely topics in thyroid tumors, Zubair W. Baloch, MD, PhD, shed light on poorly differentiated and differentiated high-grade follicular-derived carcinomas. “This is something new in the WHO 5th edition of the thyroid tumor classification scheme, and I think it’s about time that we have a different category and not really split them too much,” said Dr. Baloch, an editor and author of the 5th edition of the WHO Classification of Endocrine and Neuroendocrine Tumors. Why the category is new and what to know was part of the timely topics session, for which he paired up with Nikolina Dioufa, MD, PhD, MSc, who spoke about noninvasive follicular thyroid neoplasm with papillary-like nuclear features and follicular variant of papillary thyroid carcinoma.
September 2025—Leaders of the Digital Pathology Association met online with CAP TODAY publisher Bob McGonnagle to talk about digital pathology and much that’s related: adoption, investment, and artificial intelligence tools. “Most people are playing catch-up,” Marilyn Bui, MD, PhD, past president of the DPA and a member of the association’s board of directors, said of digital pathology. Of AI and digital pathology, DPA Foundation president Michael Rivers of Roche Tissue Diagnostics said, “Over the next several years we’re going to see a transformation in pathology.”
September 2025—Enrollment is underway now for a new CAP study that will make it possible for individual and integrated laboratories to compare inpatient analyte volumes and identify ordering practice problems. “This study is the first by the CAP that will allow system laboratories to evaluate a quality metric—inpatient test utilization—across all laboratories within their system and in comparison to like system laboratories across the U.S. and beyond,” says Richard Brown, MD, former chair and now advisor to the CAP Quality Practices Committee, whose members developed the study.
September 2025—The efficacy of human epidermal growth factor receptor 2 antibody-drug conjugate therapy for treating HER2-low breast cancers necessitates more accurate and reproducible HER2 IHC scoring. The authors conducted a study to validate the performance and utility of a fully automated artificial intelligence (AI) solution for interpreting HER2 IHC in breast carcinoma. In the two-arm multireader study of 120 HER2 IHC whole slide images from four sites, four surgical pathologists assessed HER2 scoring with and without the aid of an AI solution. Both arms of the study were compared with high-confidence ground truth established by agreement of at least four of five breast pathology subspecialists according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 and 2023 guidelines. The mean interobserver agreement among the ground truth pathologists across all HER2 scores was 72.4 percent (n =120).
September 2025—When someone dies suddenly and unexpectedly, a forensic autopsy is often performed to identify the manner and cause of death. However, up to 30 percent of autopsies fail to identify any underlying anatomic or toxicologic etiologies, and the autopsy classification may be sudden unexplained death. This is particularly concerning in young people, in whom the cause could be an inherited genetic condition that could also affect family members. Therefore, postmortem genetic testing, also known as a molecular autopsy, may have utility in identifying underlying inherited diseases that could contribute to death. In many cases, sudden death is due to cardiac factors, but the type of cardiac dysfunction may depend on age.