LGC acquires Kova International
November 2023—LGC Clinical Diagnostics announced the acquisition of Kova International, a developer and manufacturer of in vitro urinalysis and toxicology quality control products for clinical laboratories.
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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BioMérieux announces CE mark for Vidas TBI test
November 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. It aims to fill a gap in patient screening methods by ruling out acute intracranial lesions and helping to determine if a CT scan is necessary.
Bio SB launches TintoStainer Plus automatic IHC stainer
November 2023—Bio SB has launched a fully automated immunohistochemistry platform for deparaffinization and antigen retrieval and staining. Applications include immunohistochemistry, Mohs IHC, immunocytochemistry, and immunofluorescence of formalin-fixed, paraffin-embedded tissue, frozen tissue, and cell specimens.
FDA clears Nova Prime Plus for microcapillary sample mode
November 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.
FDA approves Qiagen CDx for GIST
November 2023—Qiagen announced FDA approval of its Therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors (GIST) who may be eligible for treatment with avapritinib (Ayvakit, Blueprint Medicines). Ayvakit is approved in the United States for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Qiagen says its kit is the first PDGFRA assay to receive FDA approval as a companion diagnostic.
FloBio bleeding risk Dx gets FDA breakthrough device designation
November 2023—FloBio announced that the FDA has granted breakthrough device designation for its rapid bleeding risk diagnostic test. The point-of-care test is designed for in vitro diagnostic use to determine blood clotting status and whether a patient is on a direct oral anticoagulant.
FDA clears Aptiva Connective Tissue Disease Essential reagent
November 2023—Werfen announced FDA 510(k) clearance of its Aptiva Connective Tissue Disease Essential reagent, to aid in diagnosing connective tissue disease. The Aptiva CTD Essential complements Werfen’s previously cleared Aptiva Celiac Disease reagent.
HemoSonics Quantra awarded Innovative Technology contract
November 2023—HemoSonics announced that its Quantra hemostasis system received an Innovative Technology contract award from Vizient. The Quantra system consists of the Quantra hemostasis analyzer with QPlus and QStat cartridges and provides comprehensive whole-blood coagulation analysis at the point of care in less than 15 minutes.
Feasibililty study results evaluating Mainz advanced adenoma biomarkers
October 2023—Mainz Biomed announced results of an independent feasibility study conducted in collaboration with members of the National Cancer Institute’s Early Detection Research Network to evaluate the company’s portfolio of five mRNA biomarkers, which it acquired from Université de Sherbrooke, Quebec.
MMQCI releases BCR-ABL IS linearity panel
October 2023—Now available from Maine Molecular Quality Controls is the Xpert BCR-ABL IS p210 Linearity Panel C207. It’s intended for use as an assayed external quality control to monitor the performance of the in vitro quantitative detection of BCR-ABL1 translocation mRNA e14a2/b3a2 transcripts and the ABL1 endogenous control mRNA transcript. It is designed to be used with the Xpert BCR-ABL Ultra assay on Cepheid GeneXpert instruments. Each kit comprises 12 bottles with two bottles of each international scale percent (%IS) value in 4 mL of synthetic BCR-ABL1 RNA transcript and synthetic ABL1 control gene RNA transcript suspended in a stabilizing matrix with a noninfectious solution of buffers and preservatives.