JERSEY, Channel Islands, April 27, 2020 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today reported very strong final study performance data for its SARS-CoV-2 antibody test. The Company expects to complete the CE marking process and the submission of the FDA emergency use authorization for the MosaiQ COVID-19 Antibody Microarray in the next few days. Discussions with potential customers in Europe and the US are ongoing.
MosaiQ COVID-19 Antibody Microarray Performance
A summary of the final results for the MosaiQ COVID-19 Antibody Microarray are set out below:
|Pathogen||Sensitivity %||Specificity %|
|SARS-CoV-2 Antibody test||Expected Positives||Expected Negatives
(drawn prior to December 2019)
|Reactive on MosaiQ||59||3|
|Non-reactive on MosaiQ||0||535|
|Sensitivity: Positive percent agreement||100%|
|Specificity: Negative percent agreement||99.4%|
“I am very pleased with the exceptional results from our final study’s performance data. Our innovative MosaiQ technology delivered 100% sensitivity and 99.4% specificity, truly an outstanding performance. We are confident that we will CE mark for Europe including Switzerland and begin the FDA emergency use authorization process within a matter of days,” said Franz Walt, Chief Executive Officer of Quotient.
“The MosaiQ technology requires very low quantities of biological raw material allowing us to guarantee supply of microarrays to our customers for the foreseeable future with no lot-to-lot variation due to changes to the microarray content,” 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.
Learn more about the MosaiQ COVID-19 Antibody Microarray