- Encouraging results from a study of its MosaiQ™ multiplex molecular disease screening (MDS) Microarray
- MDS product progressing through development
- Update regarding progress on the Company's MosaiQ expanded Immunohematology (IH) microarray
- Commercial launch of Expanded IH together with already CE marked Initial SDS on track to be launched in Europe around year-end 2021
JERSEY, Channel Islands, April 05, 2021 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today reported encouraging result from a study of its MosaiQ Multiplex Molecular Disease Screening (MDS) Microarray, and provided an update regarding progress on the Company's MosaiQ™ Expanded Immunohematology (IH) microarray.
MDS product progressing through development
The Company recently completed a study that measured the sensitivity of tests performed using its MosaiQ MDS microarray. The Company found the study results to be highly encouraging because they show sensitivity that is generally consistent with that of the most sensitive, widely available molecular disease screening tests.
Manuel O. Méndez, Chief Executive Officer of Quotient, explained, "These recent results are important because they further validate our belief that our MosaiQ technology can offer a breadth of diagnostic tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms and will be transformative.”
The first commercially available MosaiQ tests will be for immunohematology (blood grouping), or IH; the second category of tests the company plans to offer will be for serological disease screening, or SDS, and the third category will be tests for molecular disease screening, or MDS. Key to implementing the Company strategy is the ability of MosaiQ to at least match the existing performance of automated platforms running each of these three separate categories of tests.
Mr. Mendéz added, “We are already well along in developing IH and SDS tests. These latest MDS test results lead us to believe that we are fully on track to delivering a single platform that will run all three categories of tests—something no other product in the market can do—and with that, improve workflow for customers. MosaiQ’s molecular diagnostic capability also offers opportunities beyond transfusion in the central laboratory market.”
The study utilized EDTA samples across titre ranges, linearity and sensitivity panels. The results are encouraging for the continuation of the development process of the expanded MDS panel.
Expanded IH Microarray
As previously reported, the Company has been seeking to improve the performance of some of the tests on the IH microarray through a series of enhancements. That work recently was completed, and preliminary data from the Company's own testing suggests the enhancements have been effective in improving performance. The Company expects to shortly resume field trials in Europe and the US that will evaluate the performance of the tests on the microarray. CE mark and US BLA submission are anticipated to be completed in the second half of calendar year 2021, assuming COVID-related restrictions on travel and business activity gradually ease in the coming months.
This IH microarray, together with the Initial SDS microarray, which is already CE marked, will represent Quotient’s first attractive commercial combination for the European donor transfusion market. The Company is targeting commercial launch of the IH microarray around year-end 2021.
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. In response to the global effort to combat COVID-19, Quotient developed the MosaiQ COVID-19 Antibody Microarray which is CE marked and has received the U.S. FDA Emergency Use Authorization. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.
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 our expectations regarding the timing and results from field trials of our products under development and the timing of applications for various regulatory clearances required for commercial sales of those products, as well as the potential for using the Company’s MosaiQ technology in infectious disease diagnostics), current estimates of third quarter and full year fiscal 2021 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, are greater than they otherwise would be because of the impact of the COVID-19 pandemic. They include COVID-related delays or disruptions of field trial studies for our products, 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 (not related to COVID) with respect to our manufacturing or product development activities or field trial studies; adverse results in connection with any 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.