Roche gets breakthrough device designation for Lp(a) assay
May 22, 2024—Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay, developed in collaboration with Amgen, has received breakthrough device designation from the FDA.
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
May 22, 2024—Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay, developed in collaboration with Amgen, has received breakthrough device designation from the FDA.
May 20, 2024—Amgen announced FDA approval of Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
May 2024—If anything keeps Arturo Casadevall, MD, PhD, lying awake at night, it’s the frogs. And the bats. Also, the patients (relatively few, at least for now) who are affected by invasive fungal diseases. Dr. Casadevall is a microbiologist and infectious diseases expert in the Johns Hopkins Division of Infectious Diseases, Department of Medicine, and the Bloomberg School of Public Health, where he’s a professor of medicine and chairs the Department of Molecular Microbiology and Immunology. In his waking hours, he looks deeply and broadly at the natural world and how the disturbing growth of fungal infections might impact the medical world. Though the arrows haven’t hit the bull’s-eye, they seem to be flying in that direction, says Dr. Casadevall, who has written widely on this topic, including “Immunity to Invasive Fungal Diseases.” In a recent interview with CAP TODAY, Dr. Casadevall spoke about how he and others in the field are thinking about how medicine might respond to this potential threat.
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.
May 2024—Many laboratories have brought order to chaos in test ordering by launching initiatives to do so, for cost and staff savings and patient care benefits. TriCore is one—it set its sights on orders for monoclonal gammopathies.
May 2024—What is a lupus anticoagulant (LA)? LA is somewhat of a misnomer. Many patients with this condition do not have systemic lupus erythematosus (SLE) and usually do not bleed. However, the in vitro phenomenon was originally described in patients with SLE, as well as other autoimmune disorders—thus use of the term “lupus,” and this does often lead to prolonged in vitro coagulation testing—thus use of the term “anticoagulant.”
May 2024—The number of “champions” who have joined the CAP’s Future Pathologist Champion program grew from 71 in 2022 to 135 in 2023 and now stands at 222, and the goal is to reach 250 by the end of this year.
Four views of artificial intelligence in pathology and laboratory medicine. That’s what panelists provided for attendees at the 7th Clinical Lab 2.0 workshop in late February in Chicago. The University of Michigan’s Ulysses G. J. Balis, MD, spoke of AI’s use in laboratory operations and diagnostics. Tom Neufelder of Beckman Coulter spotlighted its use in instruments and postanalytically. Gaurav Sharma, MD, of Henry Ford Health is the skeptic, and the University of Pittsburgh’s Michael Becich, MD, PhD, is the rabid enthusiast who is working to unite pathology’s reports and calls himself a data plumber.
May 2024—Laboratory-developed testing as it relates to next-generation sequencing was up first in the NGS conversation led online by CAP TODAY publisher Bob McGonnagle on March 19. Other topics: in-house NGS testing, artificial intelligence, and bioinformatics. “There’s a reality now where bioinformatics is solid, stable, and reliable,” said José Luis Costa, PhD, of Thermo Fisher Scientific.
May 2024—Classically, immunohistochemical expression of small cell lung cancer (SCLC) is characterized by strong expression of neuroendocrine markers, notably synaptophysin, chromogranin A, insulinoma-associated protein 1 (INSM1), and CD-56. However, up to 20 percent of SCLCs demonstrate low or no expression of neuroendocrine (NE) markers by IHC and are termed “NE-low/negative.”