- Initial feasibility study demonstrates ability to detect nucleic acid using MosaiQTM
- Potential for a single unified platform to perform blood grouping along with serological and molecular disease screening
- Groundbreaking solution envisioned for donor testing market of transfusion diagnostics; would eliminate need to pool samples
JERSEY, Channel Islands, Jan. 11, 2016 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced a planned major expansion for the intended use of its MosaiQ™ transfusion diagnostics platform to include nucleic acid testing (“NAT”) for donor molecular disease screening. If successfully developed, the additional NAT capability for MosaiQ™ would be groundbreaking for the global donor testing market, complementing the initial blood grouping and serological disease screening applications.
MosaiQ™ is at an advanced stage of development and commercial scale-up and represents a truly novel testing platform for transfusion diagnostics, with proven capability to detect antibodies, antigens and now nucleic acid (DNA or RNA), as described below. Through MosaiQ™, Quotient aims to provide donor testing laboratories with a unified instrument platform to be utilized for blood grouping and both serological and molecular disease screening of donated red blood cells and plasma.
In the fourth quarter of calendar 2015, Quotient completed an initial feasibility study demonstrating the ability to detect nucleic acid using the MosaiQ™ methodology. In the study, Quotient and its external development partner successfully detected DNA sequences of the conserved region of the human immunodeficiency virus (“HIV”). This meaningful advancement enables Quotient to move forward with the next phase of product development for NAT on the MosaiQ™ platform, which involves further assay development and expansion of the test menu to include the Hepatitis B, Hepatitis C and West Nile viruses. We expect to complete this next phase of development work during the first half of 2017.
The incorporation of NAT on the MosaiQ™ platform will offer considerable advantages over existing approaches currently in use by donor testing laboratories, delivering operational cost savings and a reduced time to result, while also eliminating the need to pool samples. Working with its development partner, Quotient intends to redeploy existing internal resources on development of the additional NAT applications following completion of assay development for the blood grouping and serological disease screening applications.
“Molecular disease screening for donated blood and plasma is a large global market opportunity, with annual reagent sales exceeding $1.5 billion, and represents a natural extension of the unique capabilities offered by our proprietary MosaiQTM technology platform,” said Paul Cowan, Quotient’s Chairman and Chief Executive Officer. “We are thrilled with the positive result of our initial efforts to expand the intended use of MosaiQTM, enabling Quotient to further differentiate its product offering relative to existing transfusion diagnostics platforms. Combined with blood grouping and serological disease screening, the addressable global market opportunity for MosaiQ™ within transfusion diagnostics exceeds $3.4 billion and significant opportunities remain for expansion into the broader field of routine medical diagnostic testing.”
About Donor Blood and Plasma Screening
The safety of donor red blood cells and plasma is ultimately the responsibility of donor collection organizations, with regulatory agencies in individual countries establishing safeguards and standards to ensure patient safety. In the developed world, donor red blood cells and plasma are subject to mandatory screening for infectious diseases before they can be released. Two different methods of testing have been adopted – a serological approach (testing for specific antigens or antibodies) and, for certain viruses, a molecular approach (testing for nucleic acid).
The United States, many countries in Western Europe and Japan require both serological and molecular disease screening to be performed on donor red blood cells and plasma. In the United States, it is mandatory to screen donor red blood cells and plasma using serological techniques for Syphilis, Hepatitis B, Hepatitis C, HIV, and Human T-Lymphotropic Antibodies. Most blood collection organizations will also screen for Cytomegalovirus (or CMV) using the same serological approach and the FDA recommends donor red blood cells to be screened for Chagas disease. Plasma collection organizations are required to serologically screen donated plasma for Hepatitis B, Hepatitis C and HIV. Molecular disease screening, utilizing NAT, is required to be performed on donated red blood cells and plasma to screen for Hepatitis B, Hepatitis C, HIV and West Nile virus.
MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms. Once approved, it will be the first fully automated solution for blood grouping, providing for the comprehensive characterization of both donor and patient blood, with turnaround times significantly quicker than existing methods. Widespread adoption of MosaiQ™ is expected to improve patient outcomes through better and easier matching of donor and patient blood, given cost-effective extended antigen typing offered by MosaiQ™. Improved patient outcomes from the use of MosaiQ™ include the potential for reduced incidence of adverse events associated with transfusion, particularly alloimmunization, where patients develop antibodies to foreign antigens introduced through transfused blood. MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories, including:
- elimination of the need for routine manual testing typically undertaken by highly skilled technicians;
- simplification of required consumables and testing processes;
- consolidation of multiple instrument platforms in donor testing laboratories;
- significant reduction in sample volume requirements;
- reduction in the number of patient/donor samples required, consumables and reagent waste; and
- more streamlined processes for matching donor units to patients.
Quotient expects to develop additional applications for MosaiQ™, starting with nucleic acid testing for donor molecular disease screening, upon completion of assay development for the blood grouping and serological disease screening applications.
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.
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 and the development, regulatory approval, commercialization and impact of MosaiQTM and other new products. 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.
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