Switzerland-based commercial-stage diagnostics company Quotient has secured Conformité Européenne (CE) Mark for its MosaiQ Extended Immunohematology (IH) Microarray.
With this marking, the firm will be able to commercialise the microarray for use with its MosaiQ instrument across the EU and those geographies where CE Mark is recognised.
Its MosaiQ platform serves as a completely automated, ‘high-performance’, all-in-one solution in blood-testing laboratory and other settings.
The CE-Marked IH microarray increases the range of tests that can be operated on the platform.
The MosaiQ Extended IH solution improves workflow, thereby leading to lower operating costs for laboratories and clinicians.
The IH microarray provides Antibody Screening, Antigen Typing, including ABO forward and reverse grouping.
Given the expanded array of features, a thorough characterisation of blood donor samples (blood typing and disease screening) becomes possible through a single test procedure, the company claimed.
Quotient CEO Manuel O. Méndez said: “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 commercialization 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.”
