Quotient, a diagnostics company headquartered in Eysins, Switzerland, has received the CE mark for its MosaiQ Extended Immunohematology (IH) Microarray.
The CE marking confirms the Extended IH Microarray meets the requirements of the European Medical Devices Directive. This allows the company to commercialise the microarray for use with its MosaiQ instrument across the European Union and other CE mark recognising geographies.
The company's MosaiQ platform offers a fully automated solution in blood-testing laboratory and other settings. The IH microarray for which the CE mark was just obtained increases the range of tests that can be run on the platform.
The newly-CE marked IH microarray offers Antibody Screening, Antigen Typing, including ABO forward and reverse grouping. This expanded array of features allows for comprehensive characterisation of blood donor samples (blood typing and disease screening) through a single test procedure.
Dr. Christine C. Ginocchio, chief scientific and medical officer, said: “By enhancing the laboratory’s ability to provide rapid, more comprehensive red blood cell phenotyping, health care providers can deliver better matched blood and reduce the risk of transfusion adverse events that may be life-threatening.”
Manuel O. Méndez, chief executive officer of Quotient, added: “We are proud to receive the CE mark for our MosaiQ Extended IH microarray and have leveraged our over 30 years of experience within transfusion diagnostics to provide a high-quality solution for laboratories and donors. We are excited to enter the MosaiQ commercialisation phase and look forward to providing our stakeholders with a suite of multimodal multiplexing capabilities to help continue to drive the value and clinical utility of the MosaiQ solution on a global scale.”
