The study was completed in collaboration with a third party and approximately 900 samples were tested. The overall concordance for the system was 98.0% against the Roche Cobas system. MosaiQ demonstrated 100% specificity. There were zero unexpected positives or cross reactivity on the microarray, while sensitivity was 95.1%. All positive samples were analyzed in duplicate or triplicate and all samples were detected at least once in the study.
“This proves that our multiplex molecular disease screening concept works, and the results of the study demonstrate an excellent performance level for this stage of development. We remain confident of achieving our goal for state-of-the-art levels of performance through the optimization of our sample preparation automation, while we continue to focus on menu expansion. We aim to complete these developments within the next 15-18 months” said Franz Walt, Chief Executive Officer.
The Company is in the early stages of developing its MDS microarray. In order to demonstrate that the concept is feasible, Quotient performed concordance testing of the early stage product against a highly developed and approved product. MDS microarrays were manufactured at the Company’s full-scale manufacturing facility in Switzerland and analyzed on the MosaiQ instrument. Sample preparation (extraction and amplification) was performed on the proof of concept automation.
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.
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), and the timing of the issuance of the Company's additional notes. 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; the Company's ability to satisfy certain closing conditions associated with the issuance of the additional notes; 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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