Sebia, Paris, France, has entered into an agreement with Janssen Biotech Inc, Horsham, Pa, for the development of an in vitro diagnostic (IVD) test that mitigates potential interference in the visualization of M-proteins during immunofixation electrophoresis, which can result from treatment with Darzalex (daratumumab).

Darzalex is a human monoclonal antibody targeting CD38 that has been shown to provide clinical benefit as a monotherapy for heavily pretreated multiple myeloma patients or, when combined with standard-of-care regimens for the treatment of multiple myeloma, for patients with earlier disease (eg, those having undergone more than one prior line of therapy).

Such newly developed treatments for multiple myeloma that use humanized monoclonal antibodies can interfere with the patient’s native antibodies in immunofixation tests, which can mislead the pathologist in interpreting the patient’s response to treatment. Immunofixation is one of the tests referenced in International Myeloma Working Group guidelines to establish the diagnosis of complete response in a patient with multiple myeloma.

The collaboration agreement covers development of the Hydrashift 2/4 daratumumab IVD reagent kit for use with Sebia’s proprietary immunofixation test, Hydragel. Janssen granted Sebia development rights, allowing Sebia to be the worldwide supplier, able to provide the IVD solution to remove daratumumab interference from the immunofixation test. Sebia’s broad market coverage ensures that patients using Darzalex in many countries throughout the world will have access to testing. The agreement is the first collaboration of its kind for Sebia. Financial details were not disclosed.

Benoit Adelus, Sebia.

Benoit Adelus, Sebia.

“We are excited about partnering with Janssen and further expanding our reach in the international diagnostic market,” says Benoit Adelus, CEO of Sebia. “This is great news for patients around the world who will now have access to a reliable IVD test. Hydrashift 2/4 daratumumab is in line with our strategy of developing innovative and advanced products for patient care.”

The IVD test is specific for patients treated by Darzalex, to be used only on Sebia’s FDA-cleared and CE-marked Hydrasys 2 agarose gel platform. It cannot be used for other patient samples, with any other interfering monoclonal antibodies, or with any other immunofixation test.

The standardized IVD technique will be sold in those countries where regulatory market approval will be obtained. The product was CE marked in December 2016. The Canadian, Japanese, and US market entry and regulatory operations are ongoing.

For more information, visit Sebia.