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FDA Clears Test for Assessing Patients Treated with Multiple Myeloma Drug

NEW YORK (360Dx) – French specialty diagnostics firm Sebia said this week that the US Food and Drug Administration has cleared the company's Hydrashift 2/4 daratumumab assay for evaluating multiple myeloma patients treated with Darzalex (daratumumab).

The assay, Sebia said, is intended for use with Hydragel IF, an in vitro diagnostic reagent, for qualitatively detecting monoclonal proteins in human serum by immunofixation electrophoresis. Hydragel IF mitigates the daratumumab-mediated interference seen in immunofixation results for patients who have been treated with Darzalex, a fully human monoclonal antibody that binds to the glycoprotein CD38, the firm added.

The assay was developed in collaboration with Janssen Biotech, which jointly developed Darzalex with Genmab. Sebia is the worldwide supplier of the assay, which received CE mark in November 2016, and runs on the Sebia Hydrasys 2 agarose gel platform.