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Quotient Limited Reports Impressive Results from an Independent SARS-CoV-2 Antibody Detection Study Conducted in Spain

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Quotient Limited (NASDAQ: QTNT) has announced successful results from an independent study in Madrid confirming the high performance of its MosaiQ COVID-19 Antibody Microarray. The study revealed 100% sensitivity and 99.8% specificity in detecting COVID-19 antibodies, aligning with previous internal findings. Conducted with over 500 samples, the test identifies both IgM and IgG antibodies, presenting significant clinical advantages. The MosaiQ system, already CE marked, aims to reshape diagnostics and is currently available for distribution in Europe. Quotient highlights the potential for future growth despite regulatory and market challenges.

Positive
  • Independent study confirms 100% sensitivity and 99.8% specificity for MosaiQ COVID-19 Antibody Microarray.
  • The test detects both IgM and IgG antibodies, providing clinical advantages.
  • CE marked as of May 1, 2020, and currently available for distribution in Europe.
Negative
  • MosaiQ system not yet cleared by the FDA for sale in the United States.
  • Ongoing risks include regulatory approvals and market acceptance challenges.

JERSEY, Channel Islands, July 20, 2020 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), headquartered in Eysins, Switzerland, today reported that an independent study conducted in Madrid, Spain has confirmed the high performance characteristics of the Company's MosaiQ COVID-19 Antibody Microarray. The independent study found the MosaiQ COVID-19 Antibody Microarray demonstrated 100% sensitivity (ability to detect COVID-19 antibodies) and 99.8% specificity (ability to rule out the presence of COVID-19 antibodies).  These findings show the same sensitivity and specificity found in the Company's own earlier tests.

The study was conducted at an independent laboratory using over 500 samples.

The MosaiQ COVID-19 Antibody Microarray detects two types of antibodies produced in response to SARS-CoV-2 infection--IgM and IgG antibodies. A test that detects both types of antibodies provides clinical advantages, because patients may develop IgM antibodies several days before they develop IgG antibodies.

“We are pleased to discover that the independent study results were consistent with our own internal findings. These results demonstrate that the MosaiQ COVID-19 Antibody Microarray achieves very high accuracy in a real-world setting,” said Franz Walt, Chief Executive Officer of Quotient.

The MosaiQ COVID-19 Antibody Microarray was CE marked (certified to meet EU requirements) as of May 1, 2020.

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 reshape the way diagnostics is 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 operational cost savings to laboratories around the world. Building on the experience from transfusion diagnostics, Quotient now developed a serological test in response to the global COVID-19 pandemic. The MosaiQ COVID-19 Antibody Microarray is CE marked and available for distribution in Europe including Switzerland, and the UK. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania. The Quotient logo, Quotient MosaiQ and MosaiQ are trademarks or registered trademarks of Quotient Limited or its subsidiaries in various jurisdictions.

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 our MosaiQ technology to test for COVID-19 antibodies). The MosaiQ system has not yet been cleared by the FDA for sale in the United States. 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, including the recent novel coronavirus (COVID-19) outbreak; 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 trademarks or registered trademarks of Quotient Limited or its subsidiaries in various jurisdictions.

Contact: Peter Buhler, Chief Financial Officer, peter.buhler@quotientbd.com; +41 22 545 52 26 


FAQ

What are the performance results of the MosaiQ COVID-19 Antibody Microarray?

The MosaiQ COVID-19 Antibody Microarray demonstrated 100% sensitivity and 99.8% specificity in detecting COVID-19 antibodies based on an independent study.

When was the MosaiQ COVID-19 Antibody Microarray CE marked?

The MosaiQ COVID-19 Antibody Microarray was CE marked on May 1, 2020.

In which regions is the MosaiQ COVID-19 Antibody Microarray available?

The MosaiQ COVID-19 Antibody Microarray is available for distribution in Europe, including Switzerland and the UK.

What types of antibodies does the MosaiQ test detect?

The MosaiQ test detects both IgM and IgG antibodies produced in response to SARS-CoV-2 infection.

What challenges does Quotient Limited face with the MosaiQ system?

Quotient Limited faces challenges such as regulatory approvals and market acceptance for the MosaiQ system, not yet cleared by the FDA.

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