- Verification & Validation (“V&V”) “head-to-head” data exceeds target concordance for blood grouping
- Overall concordance for antigen typing – 99.8%, demonstrating robustness of the MosaiQ platform
- Completion of the BioCampus sale and leaseback transaction
“Further optimization of the MosaiQ microarray manufacturing process was successfully undertaken in January, designed to improve the robustness of the MosaiQ blood grouping microarray. We are pleased to report that concordance data for the subsequent V&V head-to-head studies demonstrates continued strong performance across all antigen typing and antibody detection assays, with overall concordance of 99.8% and 99.1% respectively. I congratulate the Quotient team for achieving this milestone for the MosaiQ platform,” said Franz Walt, Interim Chief Executive Officer of Quotient. “Results of the head-to-head studies are a key element of the V&V studies, completion of which represents one of the final steps prior to commencing field trials for the initial MosaiQ blood grouping microarray.”
Results of the V&V head-to-head studies for the MosaiQ IH Microarray (the initial blood grouping microarray) indicate that MosaiQ achieved the required targeted performance compared with predicate technologies for all assays. The V&V data were derived in accordance with established protocols using microarrays manufactured in Quotient’s validated, high-volume manufacturing facility and run on field trial-ready instruments.
MosaiQ IH Microarray - Antigen Typing
A summary of the V&V head-to-head study results for antigen typing compared with the predicate technology is set out below:
|Blood Group Antigen||A||B||D||C||c||E||e||Cw||K||k|
The above results imply overall concordance of 99.8% for MosaiQ. In this study 1,282 donor samples were tested and the results compared with predicate technologies, except for little-k where 157 MosaiQ test results were confirmed manually and Cw where 592 MosaiQ test results were confirmed manually.
MosaiQ IH Microarray - Antibody Detection
The V&V head-to-head study for antibody detection achieved 99.1% concordance compared with the predicate technology. In this study 1,255 donor samples were tested.
Completion of BioCampus Sale and Leaseback
On February 20, 2018 Quotient announced it had entered into definitive agreements for the sale and leaseback of its recently completed BioCampus facility located near Edinburgh, Scotland. This sale and leaseback transaction was completed on March 23, 2018.
Upcoming Regulatory and Commercial Milestones
- European Field Trials – Quotient expects to commence European field trials shortly
- European Regulatory Approval – Upon the successful completion of European field trials Quotient expects to file promptly for European regulatory approval for the MosaiQ IH Microarray
- European Commercialization – Quotient will facilitate internal validation of MosaiQ by key target European customers following completion of the European field trial, prior to entering formal contract discussions
- U.S. Field Trials – Quotient expects U.S. field trials for the MosaiQ IH2 Microarray (incorporating a more comprehensive antigen typing menu) to follow the successful completion of European field trials for the MosaiQ IH Microarray later in CY18, with US and European Regulatory submissions following thereafter
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. These forward looking statements include statements regarding our expectations relating to our management team and the development, regulatory approval, commercialization and impact of MosaiQ. 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.