A diagnostic test for Multiple Myeloma Drugs Development Market has been developed by the in vitro diagnostics company Sebia and the French pharmaceuticals company Sanofi.
In Immunofixation Electrophoresis (IFE) tests, the test will reduce potential interference from Sanofi's investigational antibody, isatuximab.
Isatuximab is a monoclonal antibody that targets a specific CD38 epitope and has the ability to initiate actions that promote the death of programmed cell death in tumors and the activity of immunomodulators.
Sebia will be the global supplier of an in vitro diagnostic (IVD) test under the terms of the agreement.
The Hydrashift 2 / 4 isatuximab IVD kit, which will be used in conjunction with Hydragel, Sebia's exclusive IFE assay, is covered by the agreement.
However, the businesses did not disclose the deal's financial terms.
The test, in particular, is intended for use on Sebia's Hydrasys 2 platform by patients who have been treated with isatuximab.
A few different myeloma treatments utilizing monoclonal antibodies can disrupt victims' monoclonal proteins in IFE tests, which can prompt clinician blunders in deciphering patient reaction to treatments.
Jean-Marc Chermette, CEO of Sebia, stated: We are thrilled to be working with Sanofi to expand our Immunofixation product line. The upcoming Hydrashift 2 / 4 isatuximab test fits with our plan to create cutting-edge products for patient care.
"This development confirms Sebia's commitment and strategic goal to remain the market leader in providing the most cutting-edge diagnostic tools supporting the management of multiple myeloma,"
According to Sebia's press release, the company plans to apply for a CE Mark for the test in the summer and then seek FDA 510(k) clearance.