Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the companyā€™s first Companion Diagnostic (CDx). This is a major achievement for Randox following over three years of innovative development and collaboration with Novo Nordisk. The Companion Diagnostic was developed as a new option for determining the amount of medication a patient with hemophilia has received.

The Randox ConcizuTraceā„¢ ELISA (enzyme linked immunosorbent assay) is intended for the quantitative measurement of concizumab-mtci concentration in human 3.2 percent citrated plasma samples from hemophilia A and B patients after four weeks from the initiation of treatment. The measurement of the concizumab-mtci concentration is used for dose adjustment decision in accordance with the drug label.

Randoxā€™s achievement has been aligned in supporting the accuracy of dosing being ensured by the ConcizuTraceā„¢ ELISA assay.

The approved ConcizuTraceā„¢ ELISA forms a part of the Global Randox ConcizuTraceā„¢ ELISA Service Solution. The solution compiles the ConcizuTraceā„¢ ELISA Sample Collection Kit containing all the necessary components required for collection and transportation of patient blood samples, the ConcizuTraceā„¢ ELISA Companion Diagnostic (CDx) for sample analysis of hemophilia patients, and the ConcizuTraceā„¢ ELISA Web Portal to manage patient testing and access patient results, as well as logistical and technical support, globally.

The complete Randox ConcizuTraceā„¢ Service Solution ensures that with a strong network of both logistical and laboratory partners, prescribers and patients will receive their results within a 10-working day turnaround time. Testing laboratories have been recruited according to quality and technical credentials to cover global testing needs. Over the course of the collaboration, testing laboratories have become active in US, Europe and Japan as the ConcizuTraceā„¢ ELISA assay is already approved in both regions.

– This press release was originally published on the Randox website