FDA clears NanoZoomer S360MD slide scanner system
Oct. 10, 2022—Hamamatsu Photonics announced that the FDA granted 510(k) clearance to market the NanoZoomer S360MD high-throughput, automated slide scanner system for primary diagnostic use.
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
Randox releases MRSA/MSSA PCR test on Vivalytic system
Oct. 7, 2022—Randox Laboratories has added its MRSA/SA test to the Vivalytic system.
FDA clears Boston Cell Standards IHC controls for HER2, ER, PR
Oct. 6, 2022—Boston Cell Standards today announced it received 510(k) clearance from the FDA for its IHControls breast cancer panel, positive controls to monitor the performance of the immunohistochemical staining process for HER2, ER, and PR IHC assays.
Roche CDx approved to ID patients eligible for Enhertu
Oct. 5, 2022—Roche announced that the FDA has approved the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with HER2-low metastatic breast cancer for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Enhertu is a specifically engineered HER2-directed antibody drug conjugate developed and commercialized by AstraZeneca and Daiichi Sankyo.
NovoPath adds capabilities to NovoPath 360
Oct. 3, 2022—NovoPath today announced the release of enhanced integrated workflows to its software-as-a-service–based LIS platform, NovoPath 360.
Illumina unveils NovaSeq X series
Sept. 29, 2022—Illumina today announced the launch of the NovaSeq X series—NovaSeq X and NovaSeq X Plus—production-scale sequencers, which aim to enable faster, more powerful, and more sustainable sequencing.
Oncomine Dx Target test approved to ID patients for Retevmo
Sept. 28, 2022—The FDA has approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer, RET-fusion positive advanced or metastatic thyroid cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).
FDA approves T-Cell Select to automate TB testing
Sept. 22, 2022—Oxford Immunotec, a division of PerkinElmer, announced FDA approval of its T-Cell Select reagent kit for automating the company’s T-SPOT.TB test workflow for in vitro diagnostic use by certified laboratories.
FDA clears Roche Cobas Pure for low- to mid-vol labs
Sept. 19, 2022—Roche received FDA 510(k) clearance for the Cobas Pure, a compact and modular solution that combines clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing on a single platform with a footprint of about 21 square feet.
FDA clears DiaSorin Simplexa COVID-19 test
Sept. 14, 2022—DiaSorin received 510(k) clearance from the FDA for its Simplexa COVID-19 Direct kit.