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Sebia to Develop Dx Test for Sanofi Multiple Myeloma Treatment

NEW YORK – In vitro diagnostic firm Sebia announced Tuesday it is partnering with Sanofi to develop a diagnostic test to mitigate possible interference from Sanofi's investigational antibody, isatuximab, in patients with multiple myeloma.

The agreement covers the development of the Hydrashift 2/4 isatuximab IVD kit to be used in conjunction with Sebia's proprietary immunofixation electrophoresis assay called Hydragel. The test is specifically for patients treated with isatuximab and will be used on Sebia's Hydrasys 2 platform. Under the agreement, Sebia will develop the test and act as the worldwide supplier.

Financial terms of the deal were not disclosed.

Isatuximab is a monoclonal antibody targeting a specific epitope of CD38 that is capable of triggering action that promotes programmed tumor cell death and immunomodulatory activity.

Certain multiple myeloma therapies that use monoclonal antibodies can interfere with patients' monoclonal proteins in IFE tests, which can lead to clinician errors in interpreting patient responses to the therapies.  

Lisses, France-based Sebia will seek a CE mark for the test in summer 2020, and then will pursues 510(k) clearance from the US Food and Drug Administration, according to the terms of the deal.