Thursday, 16 August 2018

Sebia’s Hydrashift 2/4 daratumumab assay got FDA acceptance

24 January 2018 | News

Hydrashift 2/4 daratumumab Immunofixation assay is the result of collaboration between Sebia and Janssen Biotech to provide better tools to monitor patients with multiple myeloma

Sebia, a world leader in multiple myeloma diagnostics testing and monitoring, announces that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Hydrashift 2/4 daratumumab assay.

It is to be used with Hydragel IF, for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis.

 This in vitro diagnostic (IVD) reagent mitigates the daratumumab-mediated interference seen in Immunofixation results for patients with multiple myeloma treated with DARZALEX® (daratumumab), a fully human monoclonal antibody that binds to CD38. 

The Hydrashift 2/4 daratumumab Immunofixation assay is the result of collaboration between Sebia and Janssen Biotech to provide the clinical community with better tools to monitor patients with multiple myeloma in line with the International Myeloma Working Group’s (IMWG) latest recommendations.

Sebia received development rights from Janssen and is the worldwide supplier of this assay.

Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account





Survey Box

Will government's drug price caps trigger showdown with US?

× Please select an option to participate in the poll.
Processing...   View poll results   More polls

× You have successfully cast your vote.
{{ optionDetail.option }}{{ optionDetail.percentage }}%
{{ optionDetail.percentage }}% Complete
More polls