Sebia, the French specialty diagnostics company, has announced that it is collaborating with Janssen Biotec Inc. to develop an in vitro diagnostic (IVD) test that mitigates the potential interference darartumumab (Darzalex┬«) can cause when visualising monoclonal proteins by immunofixation electrophoresis. Daratumumab, an anti-CD38 human monoclonal antibody currently being developed by Janssen as a treatment for myeloma, shows potential both as a monotherapy and in combination with other treatments for heavily pre-treated patients. The standard practice for assessing treatment response is protein electrophoresis and immunofixation but it is well known that humanised monoclonal antibodies can interfere with patients’ native antibodies in such tests. The proposed IVD test aims to remove the daratumumab interference from the immunofixation test and Sebia will develop the Hydrashift 2/4 daratumumab IVD reagent kit for use with its proprietary immunofixation test, Hydragel. The IVD test is expected to be available soon.


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