Quotient Limited Reports Concordance Data from the MosaiQ European Field Trial
June 18 2018 - 6:30AM
Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics
company, today reported concordance data for the initial MosaiQ
blood grouping microarray generated in its European field trial,
which exceed the targeted criteria for submission for CE marking.
Under the terms of the indenture governing its 12% Senior Secured
Notes due 2023, Quotient now plans to issue an additional $36
million of notes with funding to occur within 10 business days of
the date of this press release.
“It gives me great pleasure to report positive
field trial results for our initial blood grouping microarray,”
said Franz Walt, Chief Executive Officer of Quotient. Mr. Walt
added, “The achievement of this milestone will provide access to
additional debt capital to fund the next important steps of our
development, which include a CE mark submission, initial
commercialization and the ongoing expansion of the MosaiQ test menu
to include the second antigen typing microarray, our initial
serological disease tests for CMV and Syphilis and ultimately the
full serological and molecular disease screening microarrays.”
In connection with the issuance of the
additional notes, the purchasers will also be allocated an
additional 0.6% royalty right with respect to aggregate net sales
of MosaiQ Instruments and MosaiQ Microarrays made in the donor
testing market in the United States and the European
Union.
Assay Performance
MosaiQ IH Microarray Field Trial Performance -
Antigen Typing and Antibody Detection
A summary of European field trial results
compared with the predicate technology is set out below:
Blood Group |
A |
B |
D |
C |
c |
E |
e |
Cw |
K |
k |
Concordance |
99.7% |
99.5% |
99.4% |
99.6% |
99.1% |
100.0% |
99.8% |
100.0% |
99.8% |
100.0% |
The above results imply overall concordance of
99.6% for the MosaiQ antigen typing microarray. Also in the
European field trial, the antibody detection microarray was
demonstrated to be 97.3% concordant with the predicate technology.
Greater than 3,000 donations were tested in the concordance portion
of the field trial.
Regulatory and Commercial Milestones are
Confirmed
- European Regulatory Approval – Quotient
expects to file for European regulatory approvals for our initial
MosaiQ IH microarray in the second half of calendar 2018 and for
the initial Serological Disease Screening (SDS) microarray in the
first half of calendar 2019
- European Commercialization – Quotient has
already received invitations to participate in tenders once MosaiQ
has obtained European approval for the initial IH microarray
- IH Microarray Ongoing Development – Quotient
plans for the expansion of the IH antigen testing menu during the
second half of calendar 2018
- U.S. Field Trials – Quotient expects to
commence U.S. field trials with the expanded antigen testing menu
in the first half of calendar 2019
- U.S. Regulatory Approval – Quotient expects to
file for U.S. and European regulatory approval for the expanded IH
microarray in the second half of calendar 2019
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 the
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 the development, regulatory approval,
commercialization and impact of MosaiQ and other new products, and
the timing of the issuance of the additional notes and royalty
rights. 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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