monoclonal-antibodies-300x300Sebia, a world leader in multiple myeloma (MM) diagnostics and monitoring, has entered into an agreement with Janssen Biotech for the development of an in vitro diagnostic (IVD) test that mitigates the potential interference in visualisation of M-proteins in immunofixation electrophoresis caused by DARZALEX (daratumumab).

DARZALEX is a human monoclonal antibody targeting CD38 that has been shown to provide superior clinical benefit as monotherapy in heavily pretreated multiple myeloma patients and when combined with standard of care regimens for the treatment of MM in patients with the earlier disease.

This agreement is the first collaboration of its kind for Sebia. The financial details were not disclosed.

The agreement covers the development of the Hydrashift 2/4 daratumumab IVD reagent kit for use with Sebia’s proprietary immunofixation (IF) test, Hydragel. Janssen granted Sebia development rights, allowing Sebia to be the worldwide supplier, able to provide the IVD solution to remove the daratumumab interference from the IF test. Sebia’s broad market coverage guarantees that patients using DARZALEX in many countries throughout the world will have access to testing.

It is well known that the newer treatments for multiple myeloma that use humanised monoclonal antibodies (mAbs) can interfere with the patient’s native antibodies in immunofixation tests. This can mislead the pathologist in interpreting the patient’s response to treatment.

Immunofixation is one of the tests referenced in the IMWG (International Myeloma Working Group) guidelines to establish the diagnosis of complete response in a patient with multiple myeloma.

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.

“We are excited about partnering with Janssen and further expanding our reach in the international diagnostic market,” said Benoit Adelus, CEO at Sebia. “This is great news for patients around the world who will now have access to a reliable IVD test. Hydrashift 2/4 daratumumab is in line with our strategy of developing innovative and advanced products for patient care.”

This standardised IVD technique will be sold in those countries where regulatory market approval will be obtained. The product was CE marked in December 2016. The US, Canadian and Japanese market entry and regulatory operations are ongoing.

“Sebia’s Hydrashift 2/4 daratumumab will allow for a clear reading of the patient’s results, with no interference from daratumumab on immunofixation,” said Dr Thomas Dejoie, laboratory pathologist at the Nantes University Hospital (France), using the test for evaluation purposes.

“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,” said Prof. Philippe Moreau, head of the haematology department at the Nantes University Hospital (France).

The haematology department team at the hospital presented a poster on the product during the recent ASH 2016 congress in San Diego (USA).