- 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
JERSEY, Channel Islands, March 26, 2018 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage
diagnostics company, today reported: (i) concordance data for the MosaiQ blood grouping microarray generated in recent V&V
head-to-head studies; and (ii) completion of the sale and lease back of the newly constructed BioCampus facility.
“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.”
Assay Performance
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 |
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 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 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. 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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