Quotient Limited and Theradiag Announce Partnership to Advance Autoimmune Disease Diagnostics
08 Juni 2022 - 11:08AM
Business Wire
- Partnership brings together novel technology and clinical
applications expertise to produce automated, multiplexed solutions
for advancing autoimmune diagnostics
- Expands access to $2 billion autoimmune IVD specialty market
with MosaiQ
- Targeted market introduction in the later half of CY2023;
Autoimmune IVDs path to market is typically faster and at a lower
cost than blood transfusion due to different regulatory
requirements
Regulatory News:
THERADIAG (ISIN: FR0004197747, Mnemonic: ALTER) (Paris:ALTER), a
company specializing in in vitro diagnostics and theranostics,
today announced an agreement with Quotient Limited, a
commercial-stage diagnostics company, 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), Sj�gren’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.com
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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