- Performance evaluation studies for the initial disease screening microarray demonstrate 100% sensitivity and >99% specificity for the CMV and Syphilis assays
- V&V for blood grouping is ongoing – pending a modification to the manufacturing process designed to further improve microarray performance
- Assays for the MosaiQ blood grouping Microarray continue to perform robustly
MosaiQ SDS Microarray – Assay Performance
A summary of the latest performance evaluation data generated during process validation for the MosaiQ SDS Microarray (to detect CMV and Syphilis) is set out below:
In this study a total of 548 known positive and negative samples were tested. 59% of samples tested for CMV were positive and 35% of samples tested for Syphilis were positive. The results were derived using microarrays manufactured in Quotient’s validated, high-volume manufacturing facility and run on field trial ready instruments.
The process validation studies represent the final step prior to commencing formal V&V studies for the MosaiQ SDS Microarray.
MosaiQ IH Microarray - Update
Underyling blood grouping assays for MosaiQ continue to perform to expectations. All assays required for the MosaiQ IH II Microarray (incorporating the extended antigen typing panel for donor testing) have completed development and transfer of these assays to manufacturing has commenced.
After an investigation late last year into the physical properties of the printed microarrays, specifically the preservative layer, it was decided to modify the manufacturing process for MosaiQ microarrays. The modification is expected to further improve the performance and robustness of MosaiQ, particularly as it relates to the antigen typing assays.
Following implementation of the modifications to the MosaiQ manufacturing process Quotient will recommence the V&V studies for the in MosaiQ IH Microarray, with the commencement of European field trials expected to take place shortly thereafter.
The Company continues to have high expecations for the performance of the MosaiQ system in both a field trial and customer laboratory setting.
Upcoming Regulatory and Commercial Milestones
Subject to the modifications referred to above, a complete validated manufacturing operation is now in place. Development of the MosaiQ instrument is complete and the commercially ready instruments for use in upcoming EU field trials are available. Blood grouping and disease screening assays developed for MosaiQ continue to meet their performance targets. Given this, Quotient expects a number of key development, regulatory and commercial milestones to be realized in calendar 2018, including:
- Completion of EU field trials and regulatory approval for the MosaiQ IH Microarray, the MosaiQ IH II Microarray and the MosaiQ SDS Microarray (for CMV and Syphilis)
- European Commercialization – Quotient has commenced the commercialization of MosaiQ in
Europe, where it has already been invited to participate in tenders by European donor testing agencies
- Completion of U.S. Field Trials and subsequent Regulatory Filing for the MosaiQ IH II Microarray and the MosaiQ SDS Microarray (for CMV and Syphilis)
- Completion of development for the MosaiQ IH III Microarray (for patient testing) and the MosaiQ SDS II Microarray encompassing the full serological disease screening panel for donor disease screening (for testing red cells and plasma).
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.
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
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
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of
Source: Quotient Limited