Quotient Limited Provides Update on CE Marking Progress of the MosaiQ™ Expanded Immunohematology Microarray
Quotient Limited (NASDAQ:QTNT) has initiated the review process for its Expanded Immunohematology (IH) technical file dossier by the European notified body, with part I submitted in September. CEO Manuel O. Méndez expressed satisfaction with this progress and anticipates CE Mark approval by year-end, paving the way for a commercial launch in Europe. The company's MosaiQ microarray technology aims to enhance diagnostic efficiency, offering significant workflow improvements and cost savings for labs worldwide.
- Successful submission of part I of the technical file dossier for Expanded IH.
- Anticipation of CE Mark approval around year-end.
- Positive performance feedback from European field trials.
- Regulatory approval delays could affect commercialization timelines.
JERSEY, Channel Islands, Oct. 01, 2021 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (the Company), today announced the launch of the review process of the Expanded Immunohematology (IH) technical file dossier for review by the European notified body. The Company submitted part I of the dossier in September as planned.
“As a result of the hard work by our team, we are very pleased to have submitted the beginning of the technical file dossier for our Expanded IH microarray. As communicated, we progressed as planned and look forward to providing further updates at the next earnings call,” said Manuel O. Méndez, Chief Executive Officer of Quotient.
Instrument performance regarding time to result, intuitiveness, and technical service support, continues to prove impressive to customers conducting European field trials. The Company anticipates CE Mark approval around year-end, followed by the commercial launch in the EU and other countries which accept a CE mark.
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 create operational cost savings to laboratories around the world. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania. The Quotient logo, Quotient MosaiQ and MosaiQ are registered trademarks or trademarks of Quotient Limited and 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 the Company’s MosaiQ technology to infectious disease diagnostics), current estimates of first quarter and full year fiscal 2022 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, 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 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.
CONTACT: Investor Relations; ir@quotientbd.com; +41 22 545 52 26
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