Quotient Limited and Theradiag – GuruFocus.com

  • Partnership brings together new technology and clinical application expertise to produce automated, multiplexed solutions to advance autoimmune diagnostics
  • Expands Access to $2 Billion Autoimmune Specialty IVD Market with MosaiQ
  • Targeted market introduction in the second half of CY2023; Bringing autoimmune IVDs to market is generally faster and cheaper than blood transfusion due to different regulatory requirements

JERSEY, Channel Islands, June 08, 2022 (GLOBE NEWSWIRE) — Quotient Limited (QTNT, Financial), a commercial-stage diagnostics company, today announced an agreement with Theradiag, a market leader in autoimmune disease testing and theranostics pioneer, under which the two companies will partner to advance the autoimmune diagnostics by leveraging Quotient’s MosaiQ platform.

Under this new agreement, Theradiag will supply Quotient with autoimmune reagents and multi-constituent quality controls, for the development of autoimmune microarrays for use on the MosaiQ solution. The parties anticipate that the first application covered by their new collaboration will be a solution for connective tissue diseases (TCDs). The CTD test involves a complex diagnostic pathway based on screening for anti-nuclear antibodies (ANA) and multi-tiered tests for antibodies to extractable nuclear antigens (ENA), to identify the exact autoimmune disease. Quotient believes that integrating multiple autoantibody tests into a single multiplexed test has the potential to transform autoimmune disease testing and, in doing so, speed diagnosis and treatment choice.

“Our partnership is a key step in introducing our multimodal, multiplexed MosaiQ solution to various clinical diagnostic specialty segments with the goal of enabling clinical laboratories to simplify diagnostic algorithms and accelerate standards of care. R&D expenses, allowing us to get to market faster and more cost-effectively than if we developed the new products ourselves,” said Manuel O. Méndez, CEO of Quotient.

Autoimmune diseases are one of the main causes of morbidity worldwide. Autoimmune connective tissue diseases are potentially serious systemic medical conditions such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, systemic sclerosis, polymyositis/dermatomyositis, and mixed connective tissue disease, often causing inflammation which can affect the skin, joints, kidneys, blood cells, brain, heart and lungs, with clinical symptoms mimicking many other diseases. In the United States alone, an estimated 1.5 million Americans suffer from some 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 for diagnosis.

“The signs and symptoms of autoimmune diseases can vary depending on the organ system involved and can also be generic, such as joint pain, fatigue and fever. Therefore, patients may go undiagnosed or even be misdiagnosed unless a complex series of blood tests are performed. The ability of the MosaiQ microarray to integrate multiple autoantibody tests into a single multiplexed test, using a single blood tube, provides clinicians and patients with the diagnostic tools needed to accurately guide treatment 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 IVDs are Class B or C regulated devices of the EU IVD regulations and the US FDA 510(k) and generally offer a faster and less expensive route to market than blood transfusion and other high risk tests for medical safety.

Bertrand de Castelnau, CEO of Theradiag, said: “Capitalizing on our expertise and skills in autoimmunity, we are delighted to partner with Quotient to develop new technologies and clinical applications to improve the diagnosis of these diseases. that affect so many patients around the world. By improving the test menu of the MosaiQ multiplexed platform, we will enable clinicians to more effectively diagnose autoimmune diseases. »

About Quotient Limited

Leveraging more than 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to providing solutions that it believes are reshaping the way diagnostics are performed. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated and consolidated testing platform, enabling multiple tests in different modalities. MosaiQ is designed to be a breakthrough solution, which Quotient believes will increase efficiency, improve clinical practice, deliver significant workflow improvements and create operational cost savings for laboratories worldwide. Quotient’s operations are based in Switzerland, Scotland, the United States and the United Arab Emirates.

The Quotient logo, Quotient MosaiQ and MosaiQ are either 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 more than 30 years. Theradiag was the pioneer of “theranostic” tests (combining therapy and diagnosis) which measure the effectiveness of biotherapy in the treatment of chronic inflammatory diseases. Beyond simple diagnosis, Theranostics aims to help clinicians set up a “personalized treatment” for each patient. This method promotes the individualization of treatment, the evaluation of its effectiveness and the prevention of drug resistance. To meet this challenge, Theradiag is developing and marketing the CE-marked TRACKER® range, a global solution of inestimable medical value. The Company is based in Marne-la-Vallée, near Paris, is present in more than 70 countries and employs more than 60 people. In 2021, the Company achieved a turnover of 11.1 million euros. Theradiag shares are listed on Euronext Growth Paris (ISIN: FR0004197747) and are eligible for PEA-PME. For more information on Theradiag, visit our website: www.theradiag.com

CONTACT: Investor Relations, [email protected]; +41 22 545 52 26

Forward-looking statements

This press 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, development, regulatory approval, commercialization and impact of MosaiQ and other new products (including the potential for use of the Company’s MosaiQ technology for the diagnosis of infectious diseases), current estimates of future operating results and expectations regarding our future sources of funding. These statements are based on current assumptions that involve risks and uncertainties that could cause actual 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 expansion of product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with manufacturing, product development, or field test studies; adverse results in any pending or future legal proceedings; continued or worsening adverse conditions in general domestic and global economic markets, including as a result of the global COVID-19 pandemic; as well as 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 either registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

Quotient-Limited.png

Valerie J. Wallis