FDA clears IVD assay to assess complete response in multiple myeloma

The US Food and Drug Adminstration (FDA) has granted 510(k) clearance for the Hydrashift 2/4 daratumumab assay from Sebia, which is intended for use with Hydragel IF for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis.

This in vitro diagnostic test is the result of a collaboration between Sebia and Janssen Biotech and allows for assessment of response in patients with multiple myeloma by mitigating potential interference induced by daratumumab.

“Sebia is excited to have developed such a novel and innovative IVD assay,” said Jean-Marc Chermette, Sebia’s CEO. “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.”

Sebia is a global specialty diagnostic company, develops, manufactures and commercialises IVD tests and analysers dedicated to the in vitro diagnosis of cancer, inflammatory diseases, diabetes and haemoglobin disorders.