JERSEY, Channel Islands, April 06, 2020 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today 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.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements regarding our expectations of continued growth, the development, regulatory approval, commercialization and impact of MosaiQ and other new products (including the potential for using our MosaiQ technology to test for COVID-19 antibodies). The MosaiQ system has not yet been cleared by the FDA for sale in the United States. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets, including the recent novel coronavirus (COVID-19) outbreak; as well as the other risks set forth in the Company’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.