FDA approves the Randox Concizu Trace T™ ELISA Companion Diagnostic (CDx)

Original from: Randox

Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the company’s first Companion Diagnostic (CDx). This is a major achievement for Randox following over 3 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 ConcizuTrace™ ELISA (enzyme linked immunosorbent assay) is intended for the quantitative measurement of concizumab-mtci concentration in human 3.2% citrated plasma samples from hemophilia A and B patients after 4 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.

Randox’s achievement has been aligned in supporting the accuracy of dosing being ensured by the ConcizuTrace™ ELISA assay.

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

The complete Randox ConcizuTrace™ 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 ConcizuTrace™ ELISA assay is already approved in both regions.

Source: FDA approves the Randox Concizu Trace T™ ELISA Companion Diagnostic (CDx)