JERSEY, Channel Islands, April 13, 2015 (GLOBE NEWSWIRE) -- Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today announced that results generated using the MosaiQ™ methodology demonstrated a high degree of sensitivity and specificity for its Hepatitis B Surface Antigen (HBsAg) assay. The feasibility study was conducted in collaboration with Intuitive Biosciences, Inc., and examined a total of 96 positive and negative samples.
The HBsAg assay exceeded Quotient's target of sensitivity and specificity for this phase of development, demonstrating that the MosaiQ™ methodology can be applied to HBsAg detection. Findings from the study demonstrated sensitivity of 98.6% (23 detected versus 24 positive samples) and 100% specificity (72 negative samples reported as negative). In addition, the MosaiQTM methodology detected the HBsAg standard of 0.2 International Units Per Milliliter. As a result of these positive study results, Quotient now plans to complete the development and validation of the HBsAg assay, including improvement of the analytical sensitivity for inclusion on the MosaiQTM disease screening consumable for donor testing.
"These positive initial results for our HBsAg assay further support the expanding utility of MosaiQ™ as an innovative and disruptive diagnostics platform with broad commercial application within the donor testing market of transfusion diagnostics," said Paul Cowan, Quotient's Chairman and CEO. "We have now established technical feasibility for HBsAg, Cytomegalovirus (CMV) and Syphilis assays and look forward to the development of additional assays for the detection of Hepatitis C virus (HCV), Human Immunodeficiency virus (HIV), Human T-Lymphotropic virus (HTLV) and Chagas disease (T. cruzi). This combination of assays will allow Quotient to offer a full suite of currently mandatory disease screening tests on a single consumable using MosaiQ™."
Hepatitis B is a viral infection that primarily affects the liver, causing both acute and chronic disease. The hepatitis B virus (HBV) is transmitted through contact with the blood or other bodily fluids of an infected person. Acute symptoms associated with initial infection include vomiting, yellow skin, abdominal pain and fatigue. While the majority of infections do not lead to chronic infection, most people infected around the time of birth develop chronic hepatitis B. Chronic infection can potentially lead to the development of cirrhosis of the liver and liver cancer, often resulting in death. According to the World Health organization, an estimated 240 million people are chronically infected with HBV (defined as HBsAg positive for at least 6 months), resulting in approximately 650,000 deaths each year. It is critical that all donated blood for transfusion purposes is effectively screened for HBV.
MosaiQTM is currently under development and is not available for sale in the United States. Quotient plans to begin field trials for its full donor disease screening consumable (comprising CMV, Syphilis, HBV, HCV, HIV, HTLV and T. cruzi) in 2016. The disease screening consumable for donor testing is being developed for screening both red cell and plasma donations.
About Quotient Limited
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.
About Intuitive Biosciences, Inc.
Intuitive Biosciences brings together multiplex protein detection technology with serological assays to provide products and services for the life sciences industry. The Company's Arrayed Immuno-Multiplexing™ platform delivers a continually expanding portfolio of protein analysis tools and related research services. The company's operations are based in Madison, Wisconsin.
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. 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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