Initial SDS Microarray – Assay Performance
Results of the V&V head-to-head study for the initial MosaiQ™ SDS Microarray used for the detection of CMV and Syphilis achieved the required performance compared with predicate technologies. The V&V data, which were derived using microarrays manufactured in Quotient’s ISO audited manufacturing facility and run on the recently CE marked MosaiQ™ instrument, represent the final step before moving to field trials for the initial SDS microarray currently planned for early in 2019. “The SDS microarray represents an important complement to the Company’s initial MosaiQ™ Immunohematology (IH) Microarray, which was submitted for CE mark approval in September 2018. We believe it also demonstrates the effectiveness of MosaiQ™ for immunoassay use both in transfusion diagnostics and in the larger clinical diagnostics market place,” said Franz Walt, the Company’s Chief Executive Officer.
A summary of the V&V head-to-head study results for the initial MosaiQ™ SDS Microarray are set out below:
|Pathogen||Sensitivity %||Specificity %|
In this V&V study, a total of 1261 samples were tested.
About Quotient Limited
Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQ™ technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland and Newtown, Pennsylvania.
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 application of MosaiQ to infectious disease diagnostics). 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; 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.
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