Quotient Limited Announces Acceptance of US FDA Emergency Use Authorization (EUA) for MosaiQ COVID-19 Nasdaq Antibody test: QTNT | Instant News


JERSEY, Channel Islands, 28 September 2020 (GLOBE NEWSWIRE) – Quotient Limited (NASDAQ:QTNT), headquartered in Eysins, Switzerland, today announced that on September 25, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the COVID-19 Quotient antibody test. The test detects antibodies produced in humans in response to the SARS-CoV-2 virus using Quotient’s proprietary MosaiQ blood testing microarray technology. An antibody test marked CE as of 1 May 2020 and is now available in Europe and the US.

As previously announced, Quotient has signed a contract to supply COVID-19 antibody tests to customers in the U.S. One such customer, Bloodworks Northwest, is looking for sources of recovered blood plasma taken from a donor whose blood contains SARS-CoV-2 virus antibodies. for use in treating COVID-19 patients.

Franz Walt, Quotient’s Chief Executive Officer, said, “The publication of EUA is an important milestone for Quotient, as this is the first MosaiQ test to receive FDA authorization. Prior to awarding EUA, the FDA not only reviewed our COVID-19 antibody test but also the MosaiQ Instrument and software related. Now that the innovative and new MosaiQ technology has gone through the FDA review process, we are optimistic about the prospects for future FDA approval for Quotient’s other blood testing products in our channel. These products are all based on the MosaiQ technology platform which the same. “

Further iindependent external evaluation from the COVID-19 Quotient antibody test

Quotient believes customers find the COVID-19 antibody test attractive because it is very accurate and the MosaiQ system is efficient. The tests were conducted on Quotient’s fully automated high-throughput MosaiQ instrument. A single MosaiQ test instrument can process up to 3,000 antibody tests per day. Independent studies continue to ensure that the MosaiQ COVID-19 Quotient antibody testing system is highly accurate and efficient. In the September issue of the Journal of Clinical Virology, the French Military Medical Laboratory and the French Military Biomedical Research Institute published an independent external study evaluating the MosaiQ COVID-19 Antibody Microarray and MosaiQ system. It was concluded that the clinical specificity of the test was 100%, and that the sensitivity was over 98% in samples taken more than 14 days after the onset of COVID-19 symptoms. The evaluation also concluded that the MosaiQ system “allows fast sample throughput, and single-use microarrays are in high demand for managing large quantities of samples in a limited time with low levels of laboratory technician support”. Recent results from an independent third-party study evaluation in Scotland also confirm the high performance attributes of the MosaiQ COVID-19 Antibody Microarray.

About Quotient Limited

Building on more than 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to providing 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, enabling multiple tests across multiple modalities. MosaiQ is designed to be a game-changing solution that Quotient says will increase efficiency, improve clinical practice, provide significant workflow improvements, and operational cost savings to laboratories around the world. Serological tests were developed in April 2020 in response to the global COVID-19 pandemic. The MosaiQ COVID-19 Antibody Microarray is CE marked and subject to an Emergency Use Authorization issued by the US Food and Drug Administration. The COVID-19 antibody test is available for distribution in the US, EU, UK and Switzerland. Quotient operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.

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 about our expectations of continued growth, development, regulatory approval, commercialization and impact of MosaiQ and other new products (including the potential to use our MosaiQ technology to test for COVID-19 antibodies). These statements are based on current assumptions involving risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties, many of which are beyond our control, include suspension or denial of regulatory approval or permission for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansion and product development, clinical, sales and marketing activities on operating costs; delays or other unforeseen problems in connection with manufacturing, product development, or field trial studies; adverse results in connection with ongoing or future legal proceedings; persistent or worsening adverse conditions in the domestic and global economic markets in general, including the outbreak of the new coronavirus (COVID-19); as well as other risks as specified in the Company’s submissions to the Securities and Exchange Commission. Investors are cautioned against relying too heavily on these forward-looking statements, which only take effect on the date of this agreement. The quotient denies 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, Director of Finance, [email protected]; +41 2 545 52 26

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