Quotient Limited , a commercial-stage diagnostics company , headquartered in Eysins, Switzerland, announced the completion of the development phase of a microarray based SARS-CoV-2 (COVID-19) antibody test for the fully automated high throughput MosaiQ system in response to the global COVID-19 pandemic. One MosaiQ instrument can process up to 3000 antibody tests per day.
“In the global effort to help contain the rapid spread of the new strain of coronavirus, we believe that the MosaiQ technology can provide healthcare workers with an efficient and reliable, high-volume antibody test. The development phase is now complete, and the manufacturing process has been initiated at our facility in Eysins, Switzerland. We anticipate that a commercially ready research-use-only (RUO) product in Europe will be available as early as next week,” said Franz Walt, Chief Executive Officer of Quotient.
The ability to quickly test whether people have developed antibodies due to infection is critical in supporting the response to the global COVID-19 pandemic. This is especially important as patients exposed to SARS-CoV-2 frequently have mild or no symptoms. The antibody test has a broad range of applications such as the ability to identify individuals who would require vaccination once available, and those who could safely return to work. This is especially important for frontline healthcare professionals and others who face significant potential exposure to the virus.
“Having completed the rapid development of the assay, our internal testing has demonstrated robust detection of SARS-CoV-2 antibodies. We plan to start manufacturing at our ISO13485 certified facility in Switzerland and will begin providing these tests in Europe using an RUO label. In parallel, we will initiate the steps necessary for CE mark approval of our SARS-CoV-2 test as well as FDA Emergency Use Authorization, as soon as practical. The tests can be processed using our CE marked MosaiQ instrument in a professional laboratory setting,” said Ed Farrell, Chief Operating Officer of Quotient.
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.