Roche Cobas Liat STI panels get FDA clearance, CLIA waiver
Jan. 22, 2025—Roche announced that the FDA has granted 510(k) clearance and CLIA waiver for its Cobas Liat sexually transmitted infection multiplex assay panels.
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
FDA clears AI/ML-based TriVerity for infection, sepsis
Jan. 21, 2025—Inflammatix announced that the FDA has granted marketing authorization for the TriVerity test system, a molecular test for patients with suspected acute infection or sepsis.
Mayo Clinic launches Mayo Clinic Digital Pathology
Jan. 17, 2025—Mayo Clinic announced the formation of Mayo Clinic Digital Pathology, designed on a platform architecture “to unlock the power of its archive of digital slides to revolutionize pathology and accelerate medical breakthroughs,” the organization said in its Jan. 13 press release.
QIAstat-Dx mini gastrointestinal panel gets FDA clearance
Jan. 14, 2025—Qiagen announced FDA clearance of the first in a series of QIAstat-Dx gastrointestinal panel tests for clinical use.
FDA clears Ventana DP 600 slide scanner
Jan. 13, 2025—Roche announced that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the FDA. This clearance modifies the one the company received in June 2024 for Roche Digital Pathology Dx, which includes the Ventana DP 200 slide scanner, Roche’s digital pathology workflow software and a display, and now adds the Ventana DP 600 slide scanner. The Ventana DP 600 has 40 times the capacity of the DP 200 and uses the
Sysmex to distribute, service Sentinel SentiFIT in Canada
Jan. 7, 2025—Sysmex America has signed an agreement with Sentinel Diagnostics that grants Canadian rights to distribute and service Sentinel Diagnostics SentiFIT 270 and 800 analyzers as part of a new fecal immunochemical test.
ARUP launches assay for influenza A (H5) virus
Jan. 3, 2025—ARUP Laboratories has launched an assay for the detection and subtyping of influenza A (H5) virus.
Quest to provide clinical trial lab services for Mainz CRC test
Dec. 23, 2024—Mainz Biomed announced an agreement with Quest Diagnostics to support commercialization of the company’s next-generation screening test for colorectal cancer.
Roche gets CE mark for Cobas Mass Spec solution
Dec. 20, 2024—Roche announced it has received CE mark approval for its Cobas Mass Spec solution, including the Cobas i 601 analyzer and Ionify reagent pack of four assays for steroid hormones.
BD, Babson expand access to fingertip blood testing
Dec. 19, 2024—BD and Babson Diagnostics announced an expansion of fingertip blood collection and testing technologies for use by U.S. health systems and other large provider networks in settings like urgent cares, doctor’s offices, and other ambulatory care settings.