FDA clears Randox clinical drug testing panel
April 2026—The Food and Drug Administration has granted 510(k) clearance for Randox USA’s clinical drug testing panel.
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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
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Roche.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, October 29, 2026, 1 PM-2 PM ET
Hear an expert discuss the evolving role of PD-L1 testing in HNSCC and ovarian cancer.
Webinar presenter Georgios Deftereos, MD, Professor of Pathology, Associate Director of the Clinical Cancer Genomics Laboratory, Director of Molecular Cytopathology, University of California, San Francisco
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Agilent.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, November 3, 2026, 1 PM-2 PM ET
Hear an expert discuss the challenges of detecting NRG1 fusions and how RNA-based testing can support more comprehensive fusion identification in clinical practice.
Webinar presenter Benjamin Weinberg, MD, Associate Professor of Medicine and Attending Physician
specializing in gastrointestinal medical oncology
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Diaceutics.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
assessments for solid tumors in the absence of a companion diagnostic.
Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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Interactive Product Guides
Randox Laboratories
Randox type 1 diabetes risk test gets CE mark
February 2026—Randox’s type 1 diabetes risk test has received CE marking.
FDA clears Randox clinical drug testing panel
Feb. 5, 2026—The Food and Drug Administration has granted 510(k) clearance for Randox USA’s clinical drug testing panel.
Randox launches a nitazenes array
December 2025—Randox Toxicology has launched its Nitazenes Array, an immunoassay designed to detect a broad spectrum of nitazene analogs from a single sample. The array was developed using Randox’s proprietary biochip array technology and offers a rapid turnaround time. It is available on the company’s Evidence MultiStat platform.
Randox type 1 diabetes risk test gets CE mark
Dec. 8, 2025—Randox’s type 1 diabetes risk test has received CE marking.
Randox Toxicology launches a nitazenes array
Nov. 7, 2025—Randox Toxicology has launched its Nitazenes Array, an immunoassay designed to detect a broad spectrum of nitazene analogues from a single sample.
Randox expands its operations in West Virginia
October 2025—Randox Laboratories plans to expand its facility in Jefferson County, W. Va., from a 48-person sales and distribution operation to a full-scale production laboratory. The company says the expansion will further increase its annual production of 4.1 billion tests and significantly enhance its capacity to serve customers worldwide, from hospitals, laboratories, and coroners’ offices to food safety testing facilities. The project will create opportunities for local suppliers and service providers. Once complete, the upgraded facility in Kearneysville will produce next-generation diagnostic products and equipment.
Randox unveils Evidence RABTA
August 2025—Randox has launched the Evidence RABTA (random access biochip technology analyzer), capable of processing up to 60 samples per hour and delivering up to 2,640 test results per hour. The analyzer offers seamless random access capabilities, allows users to assign samples as priority, and uses single-use tips for aspiration and dispensing. The time to first result is 36 minutes, with up to 44 results per sample. Walkaway time is up to 2.5 hours.
Randox Labs expands its operations in West Virginia
Aug. 27, 2025—Randox Laboratories plans to expand its facility in Jefferson County, W. Va., from a 48-person sales and distribution operation to a full-scale production laboratory.
FDA approves Randox ConcizuTrace ELISA CDx
July 2025—The Food and Drug Administration has approved the de novo application for Randox Laboratories’ first companion diagnostic, the Randox ConcizuTrace ELISA. The test, developed in collaboration with Novo Nordisk, is intended for the quantitative measurement of concizumab-mtci concentration in human 3.2 percent citrated plasma samples from patients with hemophilia A and B four weeks after the initiation of treatment. The measurement of the concentration is used for dose adjustment decision in accordance with the drug label.