- Performance evaluation studies confirm required concordance levels for all assays
- Verification and validation studies to commence shortly
- European field trials still expected to be completed in CY17
JERSEY, Channel Islands, Sept. 12, 2017 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported progress on performance evaluation studies for MosaiQ.
"Our latest performance evaluation results represent a key final step prior to commencing our verification and validation studies, allowing us to reaffirm our goal of completing planned field trials in Europe for MosaiQ during the second half of this year," said Paul Cowan, Chairman and Chief Executive Officer of Quotient.
Results of internal performance evaluation studies for the MosaiQ IH Microarray (the initial blood grouping microarray) and the MosaiQ SDS Microarray (the initial disease screening microarray) indicate that MosaiQ achieved the required targeted performance compared with predicate technologies. The performance evaluation data were derived using microarrays manufactured in Quotient's validated, high-volume manufacturing facility and run on field trial-ready instruments. Final internal verification and validation studies for the MosaiQ IH Microarray and MosaiQ SDS Microarray are the next step in preparation for European field trials later this year.
MosaiQ IH Microarray - Antigen Typing
A summary of the most recent performance evaluation data derived in our ongoing study for antigen typing is set out below:
|Blood Group |
In this study 571 donor samples were tested.
MosaiQ IH Microarray - Antibody Detection
The most recent performance evaluation data for the antibody detection assay achieved 99.1% concordance compared with the predicate technology. In these studies, 788 donor samples and 28 known positive samples were tested.
MosaiQ SDS Microarray
The most recent performance evaluation study for the MosaiQ SDS Microarray achieved 100% sensitivity and 98% specificity for CMV and 100% sensitivity and 100% specificity for syphilis.
Regulatory and Commercial Milestones — For Next Twelve Months are Confirmed
- European Field Trials — Quotient expects to complete European field trials during CY17
- European Regulatory Approval — Upon the successful completion of European field trials Quotient expects to file promptly for European regulatory approval for MosaiQ
- European Commercialization — Quotient has commenced the commercialization of MosaiQ in Europe, where it has already received invitations to participate in tenders to be awarded in the middle of CY18
- U.S. Field Trials and subsequent Regulatory Filing will follow the successful completion of European field trials.
MosaiQ, Quotient's next-generation platform is designed to deliver fast, comprehensive antigen typing, antibody detection and disease screening results, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified testing platform for transfusion diagnostics. Feasibility has also been demonstrated with respect to the detection of nucleic acids (DNA or RNA) using the MosaiQ platform. Through MosaiQ, Quotient expects to deliver substantial value to donor testing laboratories worldwide by providing affordable, routine comprehensive characterization and screening of blood products, on a single automated instrument platform designed to radically reduce labor costs and complexity associated with existing practice.
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.
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. 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.
CONTACT: Chris Lindop, Chief Financial Officer — firstname.lastname@example.org; +41 22 545 52 26