Sebia, Paris, has received FDA premarket notification (510(k)) clearance for its Hydrashift 2/4 daratumumab assay, intended to be used with Hydragel IF for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The in vitro diagnostic (IVD) reagent mitigates the daratumumab-mediated interference seen in immunofixation results for patients with multiple myeloma treated with Darzalex (daratumumab), a fully human monoclonal antibody that binds to CD38.
The Hydrashift 2/4 daratumumab immunofixation assay is the result of a collaboration between Sebia and Janssen Biotech Inc, Horsham, Pa, to provide the clinical community with better tools to monitor patients with multiple myeloma, in line with the latest recommendations of the International Myeloma Working Group (IMWG).
Sebia received development rights from Janssen Biotech and is the worldwide supplier of this assay. Sebia’s broad market coverage will enable patients receiving Darzalex in many countries throughout the world to have access to testing. The assay received the CE mark in November 2016.
“Sebia is excited to have developed such a novel and innovative IVD assay,” says Jean-Marc Chermette, chief executive of Sebia. “Immunofixation is one of the tests referenced in the IMWG guidelines to assess complete response in a patient with multiple myeloma. This development confirms the company’s commitment and strategic objective to remain the market leader in providing the most advanced diagnostic tools supporting multiple myeloma disease management.”
The Hydrashift 2/4 daratumumab assay is performed on the Sebia Hydrasys 2 agarose gel platform.
For more information, visit Sebia.
