Newer treatments for multiple myeloma using humanised monoclonal antibodies can interfere with the patient’s native antibodies in immunofixation tests. This can mislead the pathologist when interpreting the patient’s response to treatment.
Sebia, a multiple myeloma diagnostics and monitoring company, has entered into an agreement with Janssen Biotech for the development of an In Vitro diagnostic (IVD) test. The test mitigates the potential interference in visualisation of M-proteins in immunofixation electrophoresis.
This interference is caused by Darzalex (daratumumab), a human monoclonal antibody targeting CD38. It has been shown to provide clinical benefit as monotherapy in heavily pre-treated multiple myeloma patients.
The companies' agreement covers the development of the Hydrashift 2/4 daratumumab IVD reagent kit for use with Sebia’s immunofixation test, Hydragel.
Thomas Dejoie, laboratory pathologist at the Nantes University Hospital (France), has been using the test for evaluation purposes. He said:
“The Hydrashift 2/4 will allow for a clear reading of the patient’s results, with no interference from daratumumab on immunofixation.”
Janssen granted Sebia development rights, allowing Sebia to be the worldwide supplier providing the IVD solution to remove the daratumumab interference from the IF test.
This 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 any other immunofixation test.
Philippe Moreau, Head of the haematology department at the Nantes University Hospital, said:
“Sebia’s test has great medical potential. It is a key product in making diagnostics more efficient, precise and accurate for multiple myeloma patients treated routinely with Darzalex.”
The product was CE marked in December 2016. The US, Canadian and Japanese market entry and regulatory operations are ongoing.