The test will alleviate possible interference from Sanofi’s investigational antibody, isatuximab in Immunofixation Electrophoresis (IFE) tests.
Isatuximab is a monoclonal antibody targeting a specific epitope of CD38 capable of triggering action that promotes programmed tumour cell death and immunomodulatory activity.
Under the agreement, Sebia will develop an in vitro diagnostic (IVD) test and serve as supplier globally.
The agreement covers the growth of the Hydrashift 2 / 4 isatuximab IVD kit to be utilised in conjunction with Sebia’s proprietary IFE assay, Hydragel.
The companies, however, did not reveal the financial terms of the deal.
Specifically, the test is for patients treated with isatuximab for use on Sebia’s Hydrasys 2 platform.
Some multiple myeloma therapies using monoclonal antibodies can interfere with sufferers’ monoclonal proteins in IFE tests, which can lead to clinician errors in interpreting patient response to therapies.
Sebia CEO Jean-Marc Chermette said: “We are excited about partnering with Sanofi and further developing our Immunofixation range of products. The future Hydrashift 2 / 4 isatuximab test is in line with our strategy of developing innovative and advanced products for patient care.
“This development confirms Sebia’s commitment and strategic objective to remain the market leader in providing the most advanced diagnostic tools supporting multiple myeloma disease management.”
Sebia, in its press statement, notes that it will seek a CE Mark for the test in summer and then will pursue 510(k) clearance from the US Food and Drug Administration (FDA).