JERSEY, Channel Islands, May 17, 2018 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage
diagnostics company, today reported that it has completed the verification and validation (V&V) phase for its initial blood
grouping MosaiQ™ microarray (IH I) and has commenced its European field trials.
“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.”
Assay Performance
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 |
Concordance |
100.0% |
|
100.0% |
|
99.3% |
|
100.0% |
|
99.2% |
|
100% |
|
99.6% |
|
100.0% |
|
100.0% |
|
99.8% |
|
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 Platform
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 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
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 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.
CONTACT: Chris Lindop, Chief Financial Officer – chris.lindop@quotientbd.com; +41 22 545 52
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