“We are very encouraged by these results. The Initial SDS and the Expanded Immunohematology Microarray will be the first powerful commercial combination to hit the market. These results continue to demonstrate the effectiveness of the MosaiQ™ platform,” said Franz Walt, CEO of Quotient. Mr.Walt added, “We remain committed to our previously stated commercialization plans and expect to submit the 510(k) for the MosaiQ system together with the initial SDS Microarray for US review later this year and await the CE mark of the Initial SDS Microarray which was submitted for review in June of 2019.”
Preliminary SDS Microarray US field trial performance
|Pathogen||Sensitivity %||Specificity %|
In the US field trial, in excess of 5,000 samples were tested for Syphilis and CMV.
About Quotient Limited
Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania. The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.