Photo courtesy of Janssen
Daratumumab (Darzalex)
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sebia’s Hydrashift 2/4 daratumumab immunofixation assay.
This in vitro diagnostic test allows for assessment of response in patients with multiple myeloma by mitigating potential interference caused by the anti-CD38 antibody daratumumab (Darzalex®).
Daratumumab can interfere with the visualization of M-proteins in immunofixation electrophoresis.
The Hydrashift 2/4 daratumumab assay is intended to be used with Sebia’s Hydragel IF kit to provide qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis.
The assay is performed on Sebia’s Hydrasys 2 agarose gel platform.
The Hydrashift 2/4 daratumumab assay is the result of a collaboration between Sebia and Janssen Biotech, Inc. Sebia received development rights from Janssen and is the worldwide supplier of this assay.
The Hydrashift 2/4 daratumumab assay received the CE mark in November 2016.
