OGT, Intelliseq launch NGS reporting for myeloid malignancy panels
January 2024—OGT and Intelliseq released GeneSpect Somatic Reporter for use with OGT’s SureSeq portfolio of next-generation sequencing panels, including SureSeq myeloid panels.
Webinars and Sponsored Roundtables — Register Now
Wednesday, September 23, 2026. 12 PM-1 PM ET
Roundtable presenters Dr. David Sacks MB, ChB, FRCPath, Chairman, Steering Committee National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, September 24, 2026 11 AM-12 PM CT
This session explores the evolving role of RAS in precision oncology, from the biology of RAS mutations to the expanding landscape of targeted therapies. Through expert presentations, real-world case discussions, and interactive audience polling, participants will examine best practices for RAS biomarker testing across solid tumors, including lung, colorectal, and pancreatic cancers. The session will highlight practical considerations for tissue and liquid biopsy, strategies to address testing gaps, and the importance of multidisciplinary collaboration to ensure timely identification of patients who may benefit from RAS-targeted therapies.
Webinar presenters David Braxton, MD, Chief of Molecular Pathology Services, Hoag Family Cancer Institute & Hoag Memorial Hospital Presbyterian, and Carlos Becerra, MD, Research Director for Medical Oncology, Margaret Given Larkin Endowed Chair for Developmental Cancer Therapeutics, Hoag Memorial Hospital Presbyterian.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, October 20, 2026 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.
Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology,
Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Smart In Media launches grossing camera and software
January 2024—Smart In Media announced the release of its PathoZoom LiveView Macro camera and PathoZoom software.
FDA approves treatment for rare blood clotting disorder
January 2024—The Food and Drug Administration approved Adzynma (Takeda Pharmaceuticals), the first recombinant protein product indicated for prophylactic or on-demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.
CLSI releases jointly developed 2023 breakpoint implementation toolkit
January 2024—The Clinical and Laboratory Standards Institute, Association of Public Health Laboratories, American Society for Microbiology, the CAP, and Centers for Disease Control and Prevention have jointly developed a breakpoint implementation toolkit (BIT) to assist clinical laboratories in updating minimal inhibitory concentration breakpoints. The toolkit includes links to other resources that explain the rationale behind breakpoint updates, regulatory requirements for updating breakpoints, and detailed instructions for performing an AST breakpoint validation or verification. Manufacturers of AST systems can provide guidance on breakpoints used and clearance status with their systems.
FDA clears BD MiniDraw capillary blood collection system
January 2024—BD announced it has received FDA 510(k) clearances for its BD MiniDraw, a novel blood collection device that obtains blood samples from a fingerstick. The clearances include low-volume blood collection for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit testing.
Biocare Medical unveils IntelliPath+ staining instrument
January 2024—Biocare Medical has introduced the IntelliPath+ advanced staining instrument, intended for in vitro diagnostic use and redesigned with input from users and the latest technological advancements. It is an open system that accommodates continuous random access with immediate stat capabilities and can process 50 slides per run.
Tosoh G8 now connects to Sysmex XN-9000, XN-9100 systems
January 2024—Tosoh Bioscience has entered into an agreement with Sysmex America in which its HLC-723G8 automated glycohemoglobin analyzers can be connected to Sysmex XN-9000 and XN-9100 automated hematology systems in the United States, Latin America, and Canada. With this agreement, Tosoh says it aims to expand its HbA1c offering to the high-volume testing market and further automate hemoglobin A1c testing.
Roche launches Elecsys HBeAg quant in CE markets
January 2024—Roche launched the Elecsys HBeAg quant, an immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen in human serum and plasma. In conjunction with other laboratory results and clinical information, HBeAg quantification may be used as an aid in the diagnosis and monitoring of patients with hepatitis B viral infection. It is for use on Cobas e analyzers in countries that accept the CE mark.
FDA clears QuidelOrtho Savanna PCR platform and HSV 1+2/VZV assay
January 2024—QuidelOrtho has received FDA 510(k) clearance for its Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of herpes simplex virus types 1 and 2 and varicella zoster virus nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens from symptomatic patients.
Ad Astra QScout hematology analyzer gets 510(k) clearance
January 2024—Ad Astra Diagnostics has received 510(k) clearance from the FDA for its QScout rapid-result hematology system. The analyzer provides point-of-care white blood cell counts and a neutrophil-to-lymphocyte ratio and differentiates the number and percent of five types of mature WBCs as well as immature granulocytes. To run the test, whole blood is added to a QScout rapid leukocyte differential test, which contains a dried reagent that stains cells. When the test is inserted in the QScout analyzer, an optical system takes images and an algorithm identifies the cells in real time. Results are displayed in about two minutes.