Initial SDS Microarray – Field Trial Assay Performance
Field trial results for the initial MosaiQ SDS Microarray used for the detection of CMV and Syphilis achieved the required clinical performance. The field trial data was obtained by donor center testing laboratories using microarrays manufactured in Quotient’s ISO audited manufacturing facility and run on the CE marked MosaiQ instrument. The field trial results represent a critical step in advance of the Company’s CE marking submission for the initial SDS microarray, which is currently planned for later this quarter.
“The SDS microarray performance in a clinical setting gives me added confidence in its position as an important complement to the Company’s initial MosaiQ Immunohematology (IH) Microarray, which was submitted for CE mark approval late in
A summary of the field trial performance results comparing the initial MosaiQ SDS Microarray against currently used disease screen performance results for the initial MosaiQ SDS Microarray is provided in the table below:
In the field trial, in excess of 4600 samples were tested for CMV and for Syphilis.
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,
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
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Source: Quotient Limited