NEW YORK — Quotient Limited on Friday said that it has received CE marking for its serological disease screening (SDS) microarray.
The test runs on the company's CE marked Mosaiq system for blood grouping and transfusion-transmitted infection screening. It is designed to detect syphilis and cytomegalovirus.
"This is our third market clearance, and the CE certification of our second microarray within a year marks an important leap forward for our company as we continue to expand both our serological disease screening and immunohematology menus," Quotient CEO Franz Walt said in a statement.
Jersey, Channel Islands-based Quotient received CE marking for its immunohematology (IH) microarray last year, and recently submitted the Mosaiq system and SDS microarray to the US Food and Drug Administration for potential 510(k) clearance. It is also working on expanded IH and SDS menus.