FDA clears BioMérieux Vitek Reveal AST system
June 21, 2024—BioMérieux announced that its Vitek Reveal AST system has received FDA 510(k) clearance.
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
FDA clears Roche digital pathology solution for diagnostic use
June 18, 2024—Roche announced that its whole slide imaging system, the Roche Digital Pathology Dx, has received FDA 510(k) clearance.
Qiagen launches digital PCR assays for microbial applications
June 13, 2024—Qiagen has launched 35 wet-lab tested digital PCR microbial DNA detection assays for its digital PCR platform QIAcuity.
Bio-Rad launches GBS positive, negative run controls
June 11, 2024—Bio-Rad Laboratories has launched its Exact Diagnostics GBS positive and negative run controls.
Liaison Plex Yeast Blood Culture assay gets 510(k) clearance
June 7, 2024—Diasorin announced it has received 510(k) clearance from the FDA for the company’s Liaison Plex Yeast Blood Culture assay, the second molecular multiplexing panel on the Liaison Plex.
FDA clears Horiba Yumizen H2500 hematology analyzer
June 6, 2024—Horiba has announced that its high-throughput Yumizen H2500 hematology analyzer has received FDA 510(k) clearance and is available for sale in the United States.
Epredia SlideMate Laser gets MedTech Breakthrough Award
June 3, 2024—MedTech Breakthrough announced that Epredia has been selected as the winner of best new technology solution—pathology for its SlideMate Laser printer in the 8th annual MedTech Breakthrough Awards program.
ACLA challenges FDA final rule to regulate LDTs
May 29, 2024—The American Clinical Laboratory Association and its member company, HealthTrackRx, filed a lawsuit today against the U.S. Food and Drug Administration in the U.S. District Court for the Eastern District of Texas, challenging the agency’s May 6 final rule, which seeks to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetic Act.
FDA clears BioMérieux Vidas TBI test
May 28, 2024—BioMérieux received FDA 510(k) clearance for its Vidas TBI (GFAP, UCH-L1), a serum-based test that supports the assessment of patients with mild traumatic brain injury, including concussion.
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.