Quotient Limited and Theradiag Announce Partnership to Advance Autoimmune Disease Diagnostics

- 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 latter half of CY2023; Autoimmune IVDs path to market is typically faster and at a lower cost than blood transfusion due to different regulatory requirements

JERSEY, Channel Islands, June 8, 2022 (GLOBE NEWSWIRE) -- 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.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.