CytoCell KMT2A FISH probe kit granted de novo classification
November 2025—FDA granted de novo classification for OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic for Syndax’s menin inhibitor, Revuforj.
Webinars and Sponsored Roundtables — Register Now
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
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
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Marketplace
Tosoh gets clearance for next-gen GR01 HbA1c analyzer
November 2025—Tosoh Bioscience received FDA clearance for its HLC 723-GR01 analyzer, which uses proprietary technology to deliver A1c results in 50 seconds and detect common hemoglobin variants.
Molecular Designs submits respiratory panel for 510(k) clearance
November 2025—Molecular Designs submitted a 510(k) premarket notification to the FDA for its SimplicityDx Respiratory panel, designed to detect SARS-CoV-2, influenza A, influenza B, and RSV.
Guardant, PathGroup partner to expand access to Shield test
November 2025—Guardant Health and PathGroup are partnering to expand access to Guardant’s FDA-approved Shield blood test for colorectal cancer screening.
Data presented at ACEP25 show the utility of MeMed BV
November 2025—Presentations at the American College of Emergency Physicians Scientific Assembly 2025 highlighted MeMed BV’s effectiveness in distinguishing between bacterial and viral infections.
Quickvue Influenza + SARS test available for professional use
November 2025—QuidelOrtho’s Quickvue Influenza + SARS test, a CLIA-waived immunoassay, is now available for professional use.
QuidelOrtho launches certified analyzer program
October 2025—QuidelOrtho Corp. has launched a certified analyzer program designed to expand access to high-quality diagnostic testing in rural and community hospitals across the United States. The program is tailored for clinics, physician office labs, and small hospitals with fewer than 100 beds. Each analyzer in the program undergoes a robust, multipoint certification process at QuidelOrtho’s Rochester, NY, facility. It includes more than 140 system checks, functional adjustments, hardware cleaning or replacement, and extensive performance testing. The program features certified Vitros XT 7600 and 5600 integrated systems and the Vitros 3600 immunodiagnostic system. A 12-month warranty on service and support is included.
QuidelOrtho launches certified analyzer program
October 2025—QuidelOrtho Corp. has launched a certified analyzer program designed to expand access to high-quality diagnostic testing in rural and community hospitals across the United States. The program is tailored for clinics, physician office labs, and small hospitals with fewer than 100 beds. Each analyzer in the program undergoes a robust, multipoint certification process at QuidelOrtho’s Rochester, NY, facility. It includes more than 140 system checks, functional adjustments, hardware cleaning or replacement, and extensive performance testing. The program features certified Vitros XT 7600 and 5600 integrated systems and the Vitros 3600 immunodiagnostic system. A 12-month warranty on service and support is included.
StatLab launches PiSmart S1 slide printer
October 2025—StatLab Medical Products has launched the PiSmart S1 single hopper slide printer. The PiSmart S1 features an intuitive touchscreen interface and a compact footprint that supports on-demand printing. Four years of service is included with the use of StatLab-validated slides, which will soon be manufactured at the company’s Arlington, Tex., facility. This integrated approach—pairing printers with precision-manufactured, validated KT premium slides—creates a complete solution built for accuracy and reliability, according to a press release from StatLab.
Idylla CDx MSI test gets FDA premarket approval
October 2025—Biocartis’ Idylla CDx MSI test, developed in partnership with Bristol Myers Squibb, has received FDA premarket approval. The test aids in identifying eligible microsatellite instability-high colorectal cancer patients who may benefit from treatment with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab), as established in the CheckMate 8HW trial.