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.
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
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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.