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Quotient Limited reports the submission of the initial IH CE mark filing and the successful completion of the key regulatory audits of its new BioCampus facility
- Initial IH CE mark submission has been completed and filed on schedule
- Successful facility audits pave the way for an on time BioCampus ramp up
JERSEY, Channel Islands, Sept. 25, 2018 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported: (i) the submission of its completed dossier for the CE mark of its initial MosaiQ IH product as planned; and (ii) the successful completion of the key regulatory audits required for the consolidation of its liquid reagent manufacturing into the new Allan Robb Campus facility.
“We are happy to report the successful on time submission of the CE mark filing for our initial IH microarray. Final examination of the underlying data has shown further improvement from the field trial results we previously shared. Given potential review times we believe that setting the expectation for a commercial launch in the first half of 2019 as communicated previously, continues to be appropriate,” said Franz Walt, Chief Executive Officer of Quotient. “As important is the recent successful completion of the facility audits in connection with our liquid reagents business which give us confidence about an on-time ramp up of production in our new state of the art Allan Robb Campus.”
Greater than 3,000 donor samples were tested in the field trial and the results compared with predicate technologies. A summary of the audited head-to-head data submitted with the CE mark filing is set out below:
MosaiQ IH Microarray - Antigen Typing
|Blood Group Antigen||A||B||D||C||c||E||e||Cw||K||k|
The above results imply overall concordance of 99.8% for MosaiQ.
MosaiQ IH Microarray - Antibody Detection
The audited field trial head-to-head data for antibody detection achieved 97.5% concordance.
Quotient Reconfirms the Following Regulatory and Commercial Milestones
- European Regulatory Approval – Quotient has filed for European regulatory approvals for its initial MosaiQ IH microarray in the second half of calendar 2018 and continues to expect to file in Europe for the initial Serological Disease Screening (SDS) microarray in the first half of calendar 2019
- European Commercialization – Quotient has already received invitations to participate in tenders once MosaiQ has obtained European approval for the initial IH microarray
- IH Microarray Ongoing Development – Quotient continues to plan for the expansion of the IH antigen testing menu during the second half of calendar 2018
- U.S. Field Trials – Quotient expects to commence U.S. field trials with the expanded antigen testing menu in the first half of calendar 2019
- U.S. Regulatory Approval – Quotient expects to file for U.S. and European regulatory approval for the expanded IH microarray in the second half of calendar 2019
MosaiQ, Quotient's next-generation platform is designed to deliver fast, comprehensive antigen typing, antibody detection and disease screening results, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified testing platform for transfusion diagnostics. Feasibility has also been demonstrated with respect to the detection of nucleic acids (DNA or RNA) using the MosaiQ platform. Through MosaiQ, Quotient expects to deliver substantial value to donor testing laboratories worldwide by providing affordable, routine comprehensive characterization and screening of blood products, on a single automated instrument platform designed to radically reduce labor costs and complexity associated with existing practice.
About Quotient Limited
Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQ™ technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland 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. 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; 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 and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
CONTACT: Chris Lindop, Chief Financial Officer – email@example.com; +41 22 545 52 26