JERSEY, Channel Islands, May 01, 2020 (GLOBE NEWSWIRE) -- Quotient Limited (QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today announced that it has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE marked (Conformité Européene) its SARS-CoV-2 (COVID-19) antibody microarray. The test is now available for sale in Europe and Switzerland.
The MosaiQ COVID-19 Antibody Microarray is designed as a serological disease screen specific to COVID-19. The assay detects the IgG and IgM antibodies directed at SARS-CoV-2. In addition to the concordance studies, the Company observed seroconversions (the generation of antibodies specific to SARS-CoV-2) in two patients where diagnosis was supported by a polymerase chain reaction (PCR) assay on the patients at the time of symptoms.
In one patient, the antibody negative status changed to positive one day after the PCR positive result, and in another patient, the antibody negative status changed to positive four days post PCR result. This demonstrates that the MosaiQ antibody test can detect antibodies very early in seroconversion process.
“We are very pleased to report the completion of the CE marking process for the SARS-CoV-2 (COVID-19) assay in record time with a 100% sensitivity and 99.8% specificity claim. The test has the best in class performance and overall agreement published to date. 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,” said Franz Walt, Chief Executive Officer of Quotient.
“During our final preparations for achieving the CE Mark, our R&D team was able to further optimize one image analysis parameter, which further improved the assay specificity without changing the sensitivity,” said Ed Farrell, Chief Operating Officer.
This the Company’s fourth market clearance and the CE certification of the third Microarray within a year. The MosaiQ™ instrument is CE marked and the Company's microarray manufacturing facility is ISO 13485 certified.
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.
Forward-Looking Statements 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.
Contact: Peter Buhler, Chief Financial Officer, email@example.com; +41 22 545 52 26