Paige Lymph Node gets FDA breakthrough device designation
Nov. 7, 2023—Paige announced that the FDA has granted breakthrough device designation for Paige Lymph Node, an AI application used to detect breast cancer metastases in lymph node tissue.
Tuesday, June 9, 2026, 1:00–2:00 PM ET
In this webinar, we will examine how immune recognition after allogeneic HCT can influence leukemia relapse and disease progression. The session will highlight the clinical relevance of HLA loss of heterozygosity (LOH), approaches used for its detection, and how LOH findings may support transplant strategies, including considerations for donor selection in subsequent transplantation.
Webinar presenter Alberto Cardoso Martins Lima, PhD, Clinical consulting scientist in histocompatibility,
specializing in allogeneic hematopoietic cell transplantation (HCT) at IGEN/AFIP São Paulo and CHC/UFPR in Curitiba, Brazil
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenter Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, July 15, 2026, 1:00-2:00 PM ET
Hear an expert discuss how to integrate Kappa and Lambda in situ hybridization testing into your standard hematopathology workflow to accurately assess B-cell and plasma cell clonality. You will also gain the skills to recognize testing pitfalls in challenging reactive versus neoplastic proliferations and apply ancillary tools to resolve complex cases.
Webinar presenter Xiaojun Wu, MD, PhD, Assistant professor, Director of Hematopathology Section at NCR of Johns Hopkins Medicine Department of Pathology, SOM at Johns Hopkins University
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Nov. 7, 2023—Paige announced that the FDA has granted breakthrough device designation for Paige Lymph Node, an AI application used to detect breast cancer metastases in lymph node tissue.
Nov. 6, 2023—Roche announced that the FDA has approved the Cobas HPV test for use on its next-generation Cobas 5800 molecular instrument.
Nov. 3, 2023—Abbott has received FDA approval for its molecular human papillomavirus screening test to run on its Alinity m system.
Nov. 2, 2023—Bio-Rad Laboratories has announced the expanded compatibility of its cardiac control, Cardiac Advance, to include Beckman Coulter instruments.
Oct. 18, 2023—Roche announced the U.S. launch of its Cobas Connection Modules Vertical, designed to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care. The CCM Vertical includes elevator units, overhead conveyors, and overhead turn units that integrate with Roche’s other CCM solutions. It transports patient samples up, down, and across and between rooms; around doorways, emergency exits, and walkways; and through walls, ceilings, and floors. “The CCM Vertical is the only laboratory conveyor system in the
Oct. 17, 2023—BioMérieux announced it has received the CE mark for its Vidas TBI (GFAP, UCH-L1), a test to support the assessment of patients who have mild traumatic brain injury. The blood test measures the concentration of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1), two brain biomarkers that are released into the bloodstream during the first hour following a brain injury. The test aims to fill a gap in patient screening methods by ruling out acute intracranial
Oct. 12, 2023—OGT announced a partnership with Intelliseq, a genome informatics company and provider of next-generation sequencing analysis solutions.
Oct. 9, 2023—Bio SB has launched a fully automated immunohistochemistry platform for deparaffinization and antigen retrieval and staining.
Oct. 6, 2023—MTuitive has introduced its mTuitive Insight, a consolidated database designed to give a comprehensive view of cancer data and tie together structured data from any health care IT system.
Oct. 5, 2023—Nova Biomedical announced that the FDA has granted 510(k) clearance for a microcapillary sample mode on the company’s Stat Profile Prime Plus critical care blood gas analyzer. It is available as a standard feature.