JERSEY, Channel Islands, April 13, 2016 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced that results generated using the MosaiQTM methodology demonstrated a high degree of sensitivity and specificity for the remaining four assays to be included on the MosaiQ™ serological disease screening panel. MosaiQ™ represents a truly novel testing platform for transfusion diagnostics, with proven capability to detect antibodies, antigens and nucleic acid (DNA or RNA). Through MosaiQ™, Quotient plans to provide donor testing laboratories with a unified instrument platform to be utilized for blood grouping and both serological and molecular disease screening of donated red blood cells and plasma.
Quotient intends to initially launch MosaiQ™ into the donor testing market with a partial serological disease screening panel comprising assays for the detection of Cytomegalovirus (“CMV”) and Syphilis. Following the initial commercial launch, Quotient expects to launch a second serological disease screening consumable with a full mandated test menu, including assays for the detection of Hepatitis B (“HBV”), comprising Hepatitis B Surface Antigen and Hepatitis B Core Antibody; Hepatitis C (“HCV”); human immunodeficiency virus (“HIV”), comprising HIV Type 1 and HIV Type 2; Human T-Lymphotropic Antibodies (“HTLV”); and Chagas disease. Quotient has previously reported completion of internal validation studies on individual assays being developed to detect CMV, Syphilis, HBV Surface Antigen, HIV Type 1 and HIV Type 2.
Quotient recently completed a series of internal validation studies on individual assays being developed to detect HCV, HBV Core Antibody, HTLV, and Chagas. In these studies, Quotient used commercially available, pre-characterized samples that are designed to test and challenge the full range of sensitivity and specificity for each assay. For each assay, a total of 61 samples were tested, comprising five positive samples and 56 negatives samples. The results of these validation studies exceeded the Company’s internal performance targets.
The results of these internal validation studies are summarized in the following tables:
| Target | Sample Size | Sensitivity | Specificity | ||||
| HCV | 61 | 100.0 | % | 100.0 | % | ||
| HBV Core Antibody | 61 | 100.0 | % | 100.0 | % | ||
| HTLV | 61 | 100.0 | % | 87.5 | % | ||
| Chagas | 61 | 100.0 | % | 100.0 | % | ||
For the next stage of product development, the Company plans to complete a feasibility study for the full disease screening panel, with all mandated assays being presented on a single multiplex array.
"These results further support the expanding utility of MosaiQ™ as an innovative and highly disruptive diagnostics platform with broad commercial application within the donor testing market," said Paul Cowan, Quotient’s Chairman and CEO. “We have now established technical feasibility for all mandated assays to be included on the MosaiQ serological disease screening panel. We look forward to advancing the remaining disease screening assays to production in the second half of 2016, with internal validation and field trials to follow thereafter.”
Quotient has transfered to production the assays to be included on the disease screening consumable for the detection of CMV and Syphilis and expects to commence product validation procedures in the second quarter of 2016. The remaining serological disease screening assays are expected to be transfered to production in the second half of 2016.
About MosaiQ™
MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms. Once approved, it will be the first fully automated solution for blood grouping, providing for the comprehensive characterization of both donor and patient blood, with turnaround times significantly quicker than existing methods. Widespread adoption of MosaiQ™ is expected to improve patient outcomes through better and easier matching of donor and patient blood, given cost-effective extended antigen typing offered by MosaiQ™. Improved patient outcomes from the use of MosaiQ™ include the potential for reduced incidence of adverse events associated with transfusion, particularly alloimmunization, where patients develop antibodies to foreign antigens introduced through transfused blood. MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories, including:
- elimination of the need for routine manual testing typically undertaken by highly skilled technicians;
- simplification of required consumables and testing processes;
- consolidation of multiple instrument platforms in donor testing laboratories;
- significant reduction in sample volume requirements;
- reduction in the number of patient/donor samples required, consumables and reagent waste; and
- more streamlined processes for matching donor units to patients.
Quotient expects to develop additional applications for MosaiQ™, starting with nucleic acid testing for donor molecular disease screening, upon completion of assay development for the blood grouping and serological disease screening applications.
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 MosaiQTM 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.
Forward-Looking Statements
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 and 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.
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.