Quotient Limited Reports Results From Latest MosaiQ Performance Evaluation Studies Prior to Commencing Verification and Valid...
September 12 2017 - 8:00AM
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.
Assay Performance
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 Antigen |
A |
B |
D |
C |
c |
E |
e |
Cw |
K |
k |
Concordance |
100.0% |
99.8% |
99.4% |
99.8% |
99.6% |
100.0% |
100.0% |
100.0% |
100.0% |
100.0% |
|
|
|
|
|
|
|
|
|
|
|
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 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 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. 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 26
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