NEW YORK (360Dx) – Paris-based Sebia said today that it has inked an agreement with Janssen Biotech to develop an in vitro diagnostic test that mitigates potential interference during immunofixation electrophoresis tests that measure a patient’s response to Darzalex (daratumumab), Janssen’s FDA-approved monoclonal antibody used to treat multiple myeloma.
Financial terms of the agreement were not disclosed.
The agreement covers the development of an IVD reagent kit, Hydrashift 2/4 daratumumab, for use with Sebia’s FDA-cleared and CE-marked Hydrasys 2 agarose gel platform, Sebia said.
Darzalex is a human monoclonal antibody that targets CD38, a glycoprotein on the surface of many immune cells. The therapy is used in treating patients with multiple myeloma who have received at least three prior lines of therapy. However, multiple myeloma treatments that use human monoclonal antibodies can interfere with a patient’s native antibodies in immunofixation tests, and can mislead a pathologist interpreting the patient’s response to treatment, Sebia said.
The firm noted that Darzalex potentially interferes with visualization of M proteins when the immunofixation test is used to diagnose a complete response in the patient. The new IVD is being developed to mitigate that interference.
Under the agreement, Janssen granted rights to Sebia for the development and worldwide supply of the new IVD solution.
Sebia said that with its broad market coverage, patients using Darzalex in many countries throughout the world will have access to testing.
The firm said that the new IVD technique received the CE mark in December 2016, and Sebia is working to obtain regulatory approval that may allow entry into the US, Canadian, and Japanese markets.