Technical Feasibility Established For MosaiQ™ CMV And Syphilis Disease Screening Assays
Preliminary Study Data Meets Goals for Concordance
Jersey, Channel Islands (GLOBE NEWSWIRE) - Quotient Limited ("Quotient") (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced that results generated using the MosaiQ™ methodology demonstrated a high degree of concordance to predicate technologies screening blood for Cytomegalovirus (CMV) and Syphilis. The feasibility study was conducted in collaboration with Future Diagnostics Solutions B.V. (Wijchen, The Netherlands) and examined a total of 274 positive and negative samples.
The MosaiQ™ methodology exceeded Quotient's target of concordance levels for both the Syphilis and CMV assays. Findings from the study showed that MosaiQTM detected 29 positive Syphilis blood samples versus 29 for the comparator, while MosaiQTM did not detect Syphilis in 104 negative samples versus 104 for the comparator, representing concordance of 100%. MosaiQTM detected 113 positive CMV blood samples versus 114 for the comparator, while MosaiQTM did not detect CMV in 27 negative samples versus 27 for the comparator, representing concordance of 99.3%. As a result of the positive study results, Quotient now plans to complete the development and verification of the CMV and Syphilis assays for inclusion on the MosaiQTM disease screening consumable.
"This represents very positive concordance results for the Syphilis and CMV assays, reinforcing the utility of MosaiQ™ as an innovative and disruptive transfusion diagnostics platform. We plan to include CMV and Syphilis on the initial disease screening consumable for donor testing, providing this very important customer group with a highly cost effective solution that complements the blood grouping capabilities of MosaiQ™," said Paul Cowan, Chairman and Chief Executive Officer of Quotient Limited.
CMV is a common virus that infects people of all ages and cultures. Most CMV infections are typically "silent", with many infected people displaying no signs or symptoms. CMV can, however, present complications for patients that are immunosuppressed. Additionally, since CMV can cause birth defects and be passed from a pregnant woman to her unborn child, it is important to ensure that young women and women of child-bearing age do not receive transfused blood infected with CMV.
Syphilis is a sexually transmitted disease that can cause long-term complications if not detected and properly treated. Syphilis has many possible symptoms, many of which are common to other diseases, making it difficult to diagnose. People may also display mild symptoms or no symptoms at all.
MosaiQTM is currently in development and is not available for sale in the United States. The company plans to begin field trials in the second half of 2015.
About Quotient Limited
Quotient is an established, commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the development and commercialization of innovative tests, currently focused on blood grouping and serological disease screening. Quotient is developing its proprietary MosaiQTM technology platform to offer a breadth of tests that is unmatched by any commercially available transfusion diagnostic instrument platform. The company's operations are based in Edinburgh, Scotland; Newtown, Pennsylvania; and Eysins, Switzerland. For more information, please visit our web site at www.quotientbd.com.
About Future Diagnostics Solutions B.V.
Future Diagnostics is a leading provider of high-quality assay development services to the medical diagnostics, device, and biopharmaceutical industries, having established its reputation as a respected independent partner for its expertise across an array of disease areas and detection technologies. Future Diagnostics works closely with innovative companies worldwide as they require assay development support to bring novel diagnostics products to market, integrating its Quality Management System in every assay development project. For more information, please visit our web site at www.future-diagnostics.nl.
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 include statements regarding our expectations of continued growth, the development, regulatory approval, commercialization and impact of MosaiQTM and other new products and current estimates of fiscal 2015 operating results. 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. The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
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SOURCE: Quotient Biodiagnostics, Inc.