Source: Clinical Laboratory News
Janssen Biotech, a subsidiary of Johnson & Johnson, has partnered with Sebia to develop a test that mitigates the potential interference in multiple myeloma monitoring caused by Darzalex (daratumumab). Darzalex, a human monoclonal antibody targeting CD38, is used either as monotherapy in heavily pre-treated multiple myeloma patients or in combination with standard-of-care regimens for multiple myeloma patients who have undergone more than one prior round of therapy. Like other treatments that use human monoclonal antibodies, Darzalex can interfere with the visualization of a patient’s native antibodies in immunofixation electrophoresis tests. This can lead to misinterpreted test results as well as incorrect judgment of whether a patient is responding to multiple myeloma treatment.
The agreement between Janssen Biotech and Sebia covers development of the Hydrashift 2/4 daratumumab reagent kit for use with Sebia’s proprietary immunofixation test, Hydragel, which is designed to remove daratumumab interference when visualizing M-proteins. Janssen has granted Sebia development rights, enabling Sebia to act as the worldwide supplier of this test. Hydragel is specific for patients treated by Darzalex and cannot be used for patient samples with other interfering monoclonal antibodies. The test also is designed solely for use on Sebia’s Hydrasys 2 agarose gel platform.