FDA clears MeMed BV test for use on whole blood
January 2024—MeMed announced that the FDA has granted 510(k) clearance for the company’s MeMed BV test for use on whole blood samples on the MeMed Key analyzer.
Webinars and Sponsored Roundtables — Register Now
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Genomadix Cube cleared for CYP2C19 testing
January 2024—The Genomadix Cube CYP2C19 system is a PCR-based test that provides genotyping results of the *2, *3, and *17 alleles of the CYP2C19 gene from a buccal swab sample in one hour.
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.
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.