- Initial Serological Disease Screening FDA 510k Submission Received
- Commencement of EU Extended Immunohematology Field Trial Activities
“The commencement of the EU Extended IH field trial activities mark another important step forward in the development process. We feel confident in moving forward to commence the field trial activities at this time and expect to begin the US field trials in the coming months,” said Franz Walt, CEO of Quotient.
“The 510(k) application submission and receipt also marks a major step toward regulatory clearance in the world’s largest market and the subsequent initiation of U.S. hyper-care sites once approved,” added Mr. Walt.
The Company submitted a 510(k) notification on 23 December 2019 and the application was received by the FDA on 26 December 2019. As previously disclosed, the Company aims to subsequently seek U.S. regulatory approval for the Expanded Immunohematology Microarray in 2020.
About Quotient Limited
Building on 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. Quotient's operations are based in Eysins, Switzerland, Edinburgh, Scotland 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, the development, regulatory approval, commercialization and impact of MosaiQ and other new products (including the application of MosaiQ to infectious disease diagnostics), and the timing of the issuance of the Company's additional notes. 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; the Company's ability to satisfy certain closing conditions associated with the issuance of the additional notes; 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.
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