FDA clears Roche Alzheimer’s disease CSF assays
Dec. 8, 2022—Roche announced FDA 510(k) clearance of its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181) assays.
Webinars and Sponsored Roundtables — Register Now
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
Subspecialties
Interactive Product Guides
Industry News
FDA clears HemoSonics Quantra with QStat cartridge
Dec. 1, 2022—HemoSonics received FDA 510(k) clearance for the Quantra hemostasis system with QStat cartridge.
General Data launches LaserTrack Flex for histology labs
Nov. 29, 2022—General Data Healthcare launched its LaserTrack Flex cassette printer.
SeraCare launches NGS reference material for BRCA
Nov. 22, 2022—LGC SeraCare announced the availability of its Seraseq FFPE BRCA1/2 LGR Reference Material intended for use with next-generation sequencing assays or amplified nucleic-acid-based methods that identify somatic and germline variants in the BRCA1 and BRCA2 genes.
FDA approves Ventana CDx to ID patients eligible for Elahere
Nov. 17, 2022—Roche announced FDA approval of the Ventana FOLR1 (FOLR1-2.1) RxDx assay, the first immunohistochemistry companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with Elahere (mirvetuximab soravtansine-gynx).
FDA OKs PerkinElmer Eonis kit for SMA screening in newborns
Nov. 16, 2022—PerkinElmer announced that the FDA has authorized the marketing of its Eonis SCID-SMA assay kit for in vitro diagnostic use by certified laboratories for the detection of spinal muscular atrophy and severe combined immunodeficiency in newborns.
Roche launches antibody to identify PRAME protein expression
Nov. 15, 2022—Roche has launched its Anti-PRAME (EPR20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients who are suspected of having melanoma.
FDA clears Simplexa Congenital CMV Direct assay
Nov. 11, 2022—DiaSorin announced it has received FDA 510(k) clearance for its Simplexa Congenital CMV Direct kit.
ZeptoMetrix launches NATtrol MS2 bacteriophage stock
Nov. 10, 2022—ZeptoMetrix launched its NATtrol MS2 Bacteriophage quantitative stock, intended for use as an internal process control for rt-PCR assays.
Roche introduces Cobas 5800 system
Nov. 9, 2022—Roche announced plans for the U.S. launch of the Cobas 5800 system, a compact, fully-automated molecular instrument that aims to offer a flexible, PCR testing solution to help clinicians diagnose infectious diseases.