Deepull UllCore BSI test gets breakthrough device designation
Dec. 18, 2024—Deepull announced it has received breakthrough device designation from the FDA for its UllCore bloodstream infection test.
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
Dec. 18, 2024—Deepull announced it has received breakthrough device designation from the FDA for its UllCore bloodstream infection test.
Dec. 10, 2024—MeMed announced that the FDA has granted breakthrough device designation to its MeMed Severity test.
Dec. 9, 2024—BioMérieux announced that its BioFire FilmArray Tropical Fever panel has received FDA special 510(k) clearance.
Dec. 6, 2024—Qiagen announced it has reached a milestone of having more than 1,000 placements of the EZ2 Connect automated sample preparation instrument.
Dec. 3, 2024—StatLab Medical Products has launched a self-manufactured premium slide and cover glass brand.
Dec. 2, 2024—Microbiologics announced the acquisition of SensID, a manufacturer of reference materials and quality controls for molecular diagnostics, with a focus on oncology and precision medicine.
Nov. 21, 2024—Foundation Medicine announced it has received approval from the FDA for FoundationOne Liquid CDx to be used as a companion diagnostic for tepotinib (Tepmetko, EMD Serono).
Nov. 14, 2024—Mainz Biomed, a Germany-based molecular genetics diagnostic company specializing in cancer diagnostics, announced a collaborative agreement with Thermo Fisher Scientific, through its subsidiary Life Technologies Corp., in which the companies will jointly develop and potentially commercialize Mainz Biomed’s next-generation colorectal cancer screening product.
Nov. 13, 2024—Healthbit announced it will launch its LabOS (laboratory operating system) at the Association for Molecular Pathology annual meeting in Vancouver, British Columbia, Nov. 19–23.
Nov. 11, 2024—Hardy Diagnostics announced it has entered into an exclusive partnership with Swedish-based company Gradientech to distribute Gradientech’s QuickMIC system in the Unites States and Canada.