De novo classification granted for plasma cell enrichment kit
March 27, 2024—Stemcell Technologies announced that the FDA has granted de novo classification for its immunomagnetic plasma cell enrichment kit.
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
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Industry News
Gestalt demos new PathFlow features at USCAP meeting
March 26, 2024—Gestalt Diagnostics announce the launch of its AI Algorithm Evaluator, a new tool within the company’s PathFlow digital pathology platform.
Bayer, Thermo Fisher to develop NGS CDx assays
March 21, 2024—Bayer and Thermo Fisher Scientific announced that they will develop next-generation sequencing–based companion diagnostic assays to help identify patients who may benefit from Bayer’s precision cancer therapies.
Roche debuts Navify solutions at HIMSS24
March 15, 2024—Roche debuted its Navify Analytics for POC and Navify Monitoring solutions at the Healthcare Information and Management Systems Society global health conference in Orlando, March 11–15.
Sekisui gets EUA for Osom flu, SARS-CoV-2 test
March 13, 2024—Sekisui Diagnostics received EUA clearance for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings.
New ASCCP guidelines now include dual-stain triage testing
March 12, 2024—Roche Diagnostics announced the release of new guidelines from the American Society for Colposcopy and Cervical Pathology and other members of the Enduring Consensus Cervical Cancer Screening and Management Guidelines committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus infection is transforming into cervical precancer.
Pramana joins Proscia Ready
March 11, 2024—Proscia announced that Pramana, an artificial intelligence–enabled health technology company, is now a Proscia Ready partner.
FDA clears Diasorin Liaison Plex system
March 5, 2024—Diasorin announced FDA 510(k) clearance for its Liaison Plex platform and Flex respiratory assay.
Sebia gets FDA clearance for free light chain assays
Sebia announced it has received FDA 510(k) clearance for its free light chain kappa and lambda assays, intended to aid in diagnosing and monitoring patients who have multiple myeloma or immunoglobulin light chain amyloidosis.
Bruker to acquire EliTechGroup
March 1, 2024—Bruker Corp. has entered into a definitive share purchase agreement to acquire EliTechGroup for €870 million (about $940 million) in cash, excluding EliTech’s clinical chemistry business.