Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics
company, today announced an agreement with Theradiag, a market
leader in autoimmune disease testing and pioneer in theranostics,
under which the two companies will partner to advance autoimmune
diagnostics by leveraging Quotient’s MosaiQ platform.
Under the new agreement, Theradiag will supply
Quotient with autoimmune reagents and multi-constituent quality
controls, for the development of autoimmune microarrays to be used
on the MosaiQ solution. The parties intend the first application
covered by their new collaboration will be a solution for
Connective Tissue Diseases (CTD). CTD testing involves a complex
diagnostic pathway which is based on the screening for Anti-Nuclear
Antibodies (ANA) and tiered testing for Extractable Nuclear Antigen
Antibodies (ENA), to identify the exact autoimmune disease.
Quotient believes that the integration of several autoantibody
tests into a single multiplexed assay has the potential to
transform autoimmune disease testing and by doing so to accelerate
diagnosis and therapy selection.
"Our partnership is a key step to introduce our
multimodal, multiplexed MosaiQ solution to various clinical
diagnostic specialty segments with the aim of enabling clinical
labs to simplify diagnostic algorithms and accelerate standards of
care. Also, this agreement will save Quotient product development
time and related R&D expenses, allowing us to get to market
faster and at a lower cost than if we developed the new products on
our own" said Manuel O. Méndez, Chief Executive Officer of
Quotient.
Autoimmune diseases represent one of the leading
global causes of morbidity. Connective tissue autoimmune diseases
are potentially severe, systemic medical conditions such as
Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome, Systemic
Scleroderma, Polymyositis/Dermatomyositis, and Mixed Connective
Tissue Disease, often causing inflammation that may affect skin,
joints, kidneys, blood cells, brain, heart and lungs, with clinical
symptoms mimicking many other diseases. In the United States alone,
it is estimated that 1.5 million Americans have a form of
lupus, with an incidence of approximately 16,000 new cases per
year, an annual total diagnosis and treatment cost per patient as
high as $50,000, and six years on average to diagnosis.
“The signs and symptoms of autoimmune diseases
can vary depending on the organ system involved and also be
generic, such as joint pain, fatigue and fever. Consequently,
patients may go undiagnosed or even misdiagnosed unless a complex
series of blood tests are performed. The ability of the MosaiQ
microarray to integrate several autoantibody tests into a single
multiplexed assay, using a single tube of blood, provides
clinicians and patients with the diagnostic tools needed to
accurately guide therapy and reduce tissue destruction,” said Dr.
Christine Ginocchio, Chief Scientific and Medical Officer of
Quotient.
Quotient estimates that autoimmune diagnostics
would provide an additional $2 billion addressable market
opportunity for Quotient’s MosaiQ platform. Autoimmune IVD’s are EU
IVD Regulation class B or C and US FDA 510(k) regulated devices and
typically provide a faster and lower cost path to market than blood
transfusion and other high medical safety risk tests.
Bertrand de Castelnau, Chief Executive Officer
of Theradiag, commented: “Capitalizing on our autoimmunity
expertise and competence, we are delighted to partner with Quotient
to develop new technology and clinical applications to improve the
diagnosis of these diseases that are affecting so many patients
worldwide. By improving the MosaiQ multiplexed platform test menu,
we will enable clinicians to diagnose more efficiently autoimmune
conditions.”
About Quotient Limited
Building on over 30 years of experience in
transfusion diagnostics, Quotient is a commercial-stage diagnostics
company committed to delivering solutions that it believes reshape
the way diagnostics are practiced. MosaiQ, Quotient’s proprietary
multiplex microarray technology, offers the world’s first fully
automated, consolidated testing platform, allowing for multiple
tests across different modalities. MosaiQ is designed to be a
game-changing solution, which Quotient believes will increase
efficiencies, improve clinical practice, deliver significant
workflow improvements, and create operational cost savings to
laboratories around the world. Quotient's operations are based in
Switzerland, Scotland, US and the UAE.
The Quotient logo, Quotient MosaiQ and MosaiQ
are registered trademarks or trademarks of Quotient Limited and its
subsidiaries in various jurisdictions.
About Theradiag
Theradiag is a market leader in autoimmune
disease testing and the founder of “theranostics”. Capitalizing on
its expertise in the diagnostics market, the Company has been
developing, manufacturing and marketing innovative in vitro
diagnostic (IVD) tests for over 30 years. Theradiag pioneered
“theranostics” testing (combining therapy with diagnosis), which
measures the efficacy of biotherapy in the treatment of chronic
inflammatory diseases. Going beyond mere diagnosis, Theranostics
aims to help clinicians set up “customized treatment” for each
patient. This method favors the individualization of treatment,
evaluation of its efficacy and the prevention of drug resistance.
In response to this challenge, Theradiag develops and markets the
CE-marked TRACKER® range, a comprehensive solution of inestimable
medical value. The Company is based in Marne-la-Vallée, near Paris,
has operations in over 70 countries and employs over 60 people. In
2021, the Company posted revenue of €11.1 million. The Theradiag
share is listed on Euronext Growth Paris (ISIN: FR0004197747) and
is eligible for the French PEA-PME personal equity plan. For more
information about Theradiag, please visit our website:
www.theradiag.comCONTACT: Investor Relations,
ir@quotientbd.com; +41 22 545 52 26
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 may include statements regarding our
expectations of continued growth, the development, regulatory
approval, commercialization and impact of MosaiQ and other new
products (including the potential for using the Company’s MosaiQ
technology to infectious disease diagnostics), current estimates of
upcoming operating results and expectations regarding our future
funding sources. 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 proceedings;
continued or worsening adverse conditions in the general domestic
and global economic markets, including as a result of the global
COVID-19 pandemic; 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, Quotient MosaiQ and MosaiQ
are registered trademarks or trademarks of Quotient Limited and its
subsidiaries in various jurisdictions.
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