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Quotient Gets CE Mark for Immunohematology Microarray

NEW YORK (360Dx) — Swiss diagnostics firm Quotient said on Wednesday that it has received CE marking for the first immunohematology (IH) microarray designed to run on its MosaiQ high-throughput automated testing platform.

The MosaiQ, which was CE marked in late 2018, is designed to provide antigen typing, antibody detection, and serological and molecular disease screening for blood transfusions using a single low-volume sample. In field studies, the new IH microarray achieved 97.5 percent concordance with predicate technologies in antibody detection, according to Quotient.

"The next IH microarray will move from development into field trials shortly in conjunction with the submission of the clinical data from our ongoing initial [serological disease screening] microarray's European field trial for CE Mark approval," Quotient CEO Franz Walt said in a statement. "Menu expansion plans also include a third-party evaluation of our novel approach to molecular disease screening, which we plan to complete later this year."

Walt added that the company also plans to issue later this month an additional $25 million of 12 percent senior secured notes due 2024. In December, Quotient raised $64.6 million from a public offering.