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FDA clearance granted for Hydrashift 2/4 daratumumab assay
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On 24 January 2018, Sebia, a world leader in Multiple Myeloma (MM) in-vitro diagnostic (IVD) testing and monitoring, announced that its Hydrashift 2/4 daratumumab assay has been granted clearance for use by the US Food and Drug Administration (FDA). This assay can be used to monitor MM patients treated with daratumumab (Darzalex).
Daratumumab, along with other humanized monoclonals, are known to interfere with native antibodies in immunofixation (IF) tests and lead to misinterpretation of patient response data. Hydrashift 2/4 daratumumab is used with the Hydragel Immunofixation (IF) assay to enable qualitative detection of endogenous M-protein in human serum, and specifically removes daratumumab interference.
This Hydrashift 2/4 daratumumab assay was developed in a collaboration between Sebia and Janssen Biotech, and provides an improved means of monitoring MM patients, in accordance with the latest recommendations from the International Myeloma Working Group (IMWG).
- http://ala.com/sebia-announces-fda-clearance-for-its-hydrashift-24-daratumumab-assay/
- https://www.mlo-online.com/sebia-announces-fda-clearance-hydrashift-24-daratumumab-assay
- Caillon H. et al. Overcoming the Interference of Daratumumab with Immunofixation Electrophoresis (IFE) Using an Industry-Developed Dira Test: Hydrashift 2/4 Daratumumab. Blood. 2016. DOI: 128:2063
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