Quotient Limited Reports Further Positive Data on its Initial Disease Screening Microarray and Provides Update on Blood Group...
09 January 2018 - 12:15PM
Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics
company, today reported positive data for the initial MosaiQ
disease screening microarray and provided an update on the ongoing
internal verification and validation (“V&V”) study for blood
grouping.
MosaiQ SDS Microarray – Assay
Performance
A summary of the latest performance evaluation
data generated during process validation for the MosaiQ SDS
Microarray (to detect CMV and Syphilis) is set out below:
Pathogen |
Sensitivity % |
Specificity % |
CMV |
100.0% |
99.5% |
Syphilis |
100.0% |
99.4% |
In this study a total of 548 known positive and
negative samples were tested. 59% of samples tested for CMV
were positive and 35% of samples tested for Syphilis were
positive. The results were derived using microarrays
manufactured in Quotient’s validated, high-volume manufacturing
facility and run on field trial ready instruments.
The process validation studies represent the
final step prior to commencing formal V&V studies for the
MosaiQ SDS Microarray.
MosaiQ IH Microarray -
Update
Underyling blood grouping assays for MosaiQ
continue to perform to expectations. All assays required for
the MosaiQ IH II Microarray (incorporating the extended antigen
typing panel for donor testing) have completed development and
transfer of these assays to manufacturing has commenced.
After an investigation late last year into the physical
properties of the printed microarrays, specifically the
preservative layer, it was decided to modify the manufacturing
process for MosaiQ microarrays. The modification is expected
to further improve the performance and robustness of MosaiQ,
particularly as it relates to the antigen typing assays.
Following implementation of the modifications to
the MosaiQ manufacturing process Quotient will recommence the
V&V studies for the in MosaiQ IH Microarray, with the
commencement of European field trials expected to take place
shortly thereafter.
The Company continues to have high expecations
for the performance of the MosaiQ system in both a field trial and
customer laboratory setting.
Upcoming Regulatory and Commercial
Milestones
Subject to the modifications referred to above,
a complete validated manufacturing operation is now in place.
Development of the MosaiQ instrument is complete and the
commercially ready instruments for use in upcoming EU field trials
are available. Blood grouping and disease screening assays
developed for MosaiQ continue to meet their performance
targets. Given this, Quotient expects a number of key
development, regulatory and commercial milestones to be realized in
calendar 2018, including:
- Completion of EU field trials and regulatory
approval for the MosaiQ IH Microarray, the MosaiQ IH II
Microarray and the MosaiQ SDS Microarray (for CMV and
Syphilis)
- European Commercialization – Quotient has
commenced the commercialization of MosaiQ in Europe, where it has
already been invited to participate in tenders by European donor
testing agencies
- Completion of U.S. Field Trials and subsequent
Regulatory Filing for the MosaiQ IH II Microarray
and the MosaiQ SDS Microarray (for CMV and Syphilis)
- Completion of development for the MosaiQ IH
III Microarray (for patient testing) and the MosaiQ SDS II
Microarray encompassing the full serological disease screening
panel for donor disease screening (for testing red cells and
plasma).
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. 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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