“I am very pleased to announce the start of our European field trials for IH I. This is the next important step in our rigourous development process, that included the V&V performance data which we have previously shared. We feel confident in moving forward to commence the fields trials at this time,” said Franz Walt, Quotient’s Interim Chief Executive Officer, who added, “The concordance portion of the study is moving forward and we expect to make the concordance data available in a press release some time during the month of June.”
Following the completion of the V&V studies for IH I the Company has moved into its European field trial. 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 validated instruments.
MosaiQ IH Microarray - Antigen Typing Requirement is to be 99% Concordant with Predicate
A recap of the previously disclosed 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 antigen typing on MosaiQ.
MosaiQ IH Microarray - Antibody Detection Requirement is to be 95% Concordant with Predicate
The previously disclosed V&V study concordance data for antibody detection was 99.1% concordant.
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.
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 MosaiQ™ 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
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
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Source: Quotient Limited