Linkedin X-twitter Youtube
Launch Digital Edition

Webinars and Sponsored Roundtables — Register Now

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

Register Now

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

Register Now

Subspecialties

Interactive Product Guides

Subspecialties

Digging into the interpretation of TSH results

Charna Albert May 2024—In a time of wellness testing and high rates of levothyroxine prescribing for hypothyroidism, it may also be time to rethink TSH test result interpretation. Laboratory testing is more accessible now than it used to be and patients are more involved in their own care. “You’re trying to give the patient access and ability to take care of their own health. But the double-edged sword is you can start over-ordering things, and the way we’ve designed lab

Labs juggle string of LDT unknowns

July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews.

The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one.

As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.”

The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs.

Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

HPV test self-collection set in motion

July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

Mayo pathologists create and test their own AI algorithms

July 2024—A Mayo Clinic project is “democratizing artificial intelligence,” its leaders say, by enabling pathologists with varying levels of AI expertise—most of whom had never before participated in an AI project—to create and implement algorithms.

Recommendations issued on PD-L1, TMB testing

July 2024—In patients with advanced non-small cell lung cancer, a validated PD-L1 immunohistochemistry expression assay should be used, with other targetable genomic biomarker assays where appropriate, for the selection of immune checkpoint inhibitor therapies. And the appropriate validation should be performed on all specimen types and fixatives. Those are two of the six recommendations of the CAP, Association for Molecular Pathology, International Association for the Study of Lung Cancer, Pulmonary Pathology Society, and LUNGevity Foundation, released in April and now in print in their PD-L1 and tumor mutation burden testing guideline for the selection of such therapies.

Lab 2.0, Medicare 2030, AI—how they come together

July 2024—The term value-based care is spoken of often, but what part do laboratories play in it and how can they be paid for it? What is Medicare 2030, and what does it mean for laboratories? How can AI be used to practice the medicine of tomorrow? Myra Wilkerson, MD, in speaking in May at the Pathology Informatics Summit, answered these and other questions. She is chair of the Department of Laboratory Medicine and of the Diagnostic Medicine Institute at Geisinger Health in Danville, Pa. She is a founding member of the Project Santa Fe Foundation, for which she serves on its board and as treasurer. She opened her talk in May about Project Santa Fe’s Clinical Lab 2.0 model—what it looks like now and the work they’re doing. We bring to you here what she shared there.

In hematopathology, online learning mirrors practice

July 2024—The CAP’s hematopathology online education program, HPATH, is now in its 10th year, with real-world cases for which there’s real-time feedback and hundreds enrolled each year. Interesting cases, ones every hematopathologist should have experience with or be familiar with, are what the expert authors of the cases provide, says Kyle Bradley, MD, chair of the CAP Hematopathology Committee and associate professor of hematopathology at Emory University School of Medicine. Each case includes laboratory data, whole slide images, images of ancillary studies, feedback about the case and test results, and self-assessment questions. “And some of the high quality comes from brevity,” Dr. Bradley says. “We whittle down a lot of information into something very manageable and high yield for busy pathologists.”

At U of Maryland, low titer O whole blood use in trauma

July 2024—The University of Maryland Medical Center is one of many sites using low titer O whole blood in trauma cases. As of May, 720 patients at UMMC had received whole blood, and that number of patients treated since the program’s start in 2021 speaks for itself, says Bryon P. Jackson, MD, MHA, Midtown Campus laboratory director and director of blood management and associate director of transfusion medicine services.

Lab, vendor views on instruments, assays, and data

July 2024—Instruments, assays, patient flow, and IT were some of what laboratory directors and IVD company representatives spoke of when CAP TODAY publisher Bob McGonnagle convened the group online on May 3. Here’s what they said about what instruments and assays are deployed where and the considerations that come into play in large health systems.

Triage for HPV screen-positives gets a boost

June 2024—When it comes to detecting cervical precancer (CIN3), p16/Ki-67 dual stain testing cuts down on the number of colposcopies compared with using Pap cytology to triage HPV-positive patients. “Using cytology [for triage], you need to do about 32 colposcopies to identify one cervical precancer [CIN3]. If you were to switch to dual stain, it cuts it in half,” says Thomas Lorey, MD, senior consultant and former director of laboratory services for Kaiser Permanente Northern California, from which much of the data underpinning the guidelines on cervical cancer screening and management have been collected. Dr. Lorey and others are coauthors of new clinical management dual stain test recommendations, released in March by the member organizations of the Enduring Consensus Cervical Cancer Screening and Management Guidelines effort. The new recommendations address only the Roche CINtec Plus Cytology test, which detects both p16 and Ki-67 and was approved by the Food and Drug Administration in 2020.

MARKETPLACE

TRENDING