- MosaiQTM manufacturing system operating in accordance with design requirements
- Ongoing evaluation of MosaiQTM methodology continues to demonstrate concordance levels in excess of 99.0% for key blood group antigen specificities
JERSEY, Channel Islands, Sept. 08, 2016 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced the successful completion of equipment validation of the initial manufacturing system for MosaiQ™ Microarrays. The manufacturing system consists of three key elements: i) the print system; ii) the wet process; and iii) the final assembly system. All three elements are operating in accordance with original design requirements, passing internal operational qualification. Quotient will now begin product qualification procedures for MosaiQ™ with final manufactured microarrays processed using MosaiQ™ instruments. Product qualification represents the final step in overall MosaiQ™ system validation prior to the commencement of field trials.
Ongoing evaluation of the MosaiQ™ methodology continues to demonstrate concordance levels exceeding the required hurdle of 99.0% for antigen typing. Recent internal efforts have focused on determining the concordance of MosaiQ™ in multiplex format with predicate methods for five key blood group antigens (A, B, D, e and K). Assay performance using the MosaiQ™ methodology exceeded the 99.0% concordance threshold for these five antigens and there continues to be no evidence of non-specific binding across individual assays. In early October, the Company expects to report the results of an internal evaluation study using final manufactured MosaiQ™ Microarrays and field trial instruments for up to ten blood group antigens, as well as an antibody identification panel. Quotient then expects to complete an internal evaluation study of the final MosaiQ IH Microarray (blood grouping panel) and MosaiQ SDS Microarray (CMV and Syphillis detection) in October, prior to the commencement of European field trials.
“Along with delivery of field trial instruments, operational qualification of the initial manufacturing system for MosaiQ™ Microarrays is a key step in the commercial scale-up and de-risking of the MosaiQ™ project,” said Paul Cowan, Chairman and Chief Executive Officer of Quotient. “Individual assays for antigen typing continue to demonstrate strong concordance, with levels consistently exceeding the required hurdle of 99.0%, and we look forward to reporting expanded data sets for the MosaiQ™ IH Microarray in October. We remain confident in our ability to deliver a highly differentiated diagnostics platform to the $3.4 billion global transfusion diagnostics market in early 2017, significantly reducing costs for customers, while advancing patient care.”
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 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.