Tag Archives: Sebia

April 2024—Sebia announced it has received FDA 510(k) clearance for its free light chain kappa and lambda assays, intended to aid in diagnosing and monitoring patients who have multiple myeloma and immunoglobulin light chain amyloidosis. The assays quantify kappa or lambda free light chains in human serum using an enzyme-linked immunosorbent assay procedure. The kits are for in vitro diagnostic use only.

Sebia announced it has received FDA 510(k) clearance for its free light chain kappa and lambda assays, intended to aid in diagnosing and monitoring patients who have multiple myeloma or immunoglobulin light chain amyloidosis.

December 2022—Sebia announced the acquisition of Zeus Scientific, an in vitro diagnostic company based in Branchburg, NJ. Sebia, headquartered in Lisses, France, says the acquisition will expand its capabilities and product portfolio in autoimmunity and reinforce its operations and footprint in the United States. Financial terms of the agreement are undisclosed.

Oct. 17, 2022—Sebia announced the acquisition of Zeus Scientific, an in vitro diagnostic company based in Branchburg, NJ.

May 2018—Sebia launched two CE-marked serum free light chain assays, Sebia FLC Kappa and Sebia FLC Lambda, for multiple myeloma testing. The two assays aim to provide more consistent results by overcoming the challenges in analytical performance and coherence encountered in current testing methods.

April 2018—Sebia 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.

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 ...