May 2020—Thermo Fisher Scientific has signed an agreement with Janssen Biotech to co-develop a companion diagnostic in oncology. The diagnostic will support clinical trial enrollment worldwide.
Read More »Home >> Tag Archives: Janssen Biotech
FDA clears Sebia Hydrashift 2/4 daratumumab assay
Feb. 26, 2018—Sebia announced it has received FDA 510(k) clearance for its Hydrashift 2/4 daratumumab assay, intended to be used with Hydragel IF, for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. This in vitro diagnostic reagent mitigates the daratumumab-mediated interference seen in immunofixation results for patients with multiple myeloma treated with Darzalex (daratumumab), a fully ...
Read More »