- Antibody Detection – enhanced detection versus predicate technologies
- Manufacturing of Microarrays for European field trials planned to commence in early April
- MosaiQ ™ instrument development completed and formal validation has commenced
- Completion of European field trials expected in mid 2017
JERSEY, Channel Islands, March 30, 2017 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ: QTNT ), a commercial-stage diagnostics company, today announced continued positive results from internal performance evaluation studies designed to evaluate the effectiveness of MosaiQ™ for blood grouping (both antigen typing and antibody detection) and donor disease screening. These studies have been conducted using MosaiQ™ microarrays manufactured in our Eysins, Switzerland facility and the Company’s proprietary MosaiQ Instrument.
Paul Cowan, Chairman and Chief Executive Officer of Quotient, commented, “I am pleased with this affirmation of the important investments we have made in state of the art technologies designed to transform transfusion diagnostics. Our plan has always been to deliver well established assays used for characterizing and testing blood in a highly automated, microarray enabled test. We are more confident than ever in achieving our objective, which continues to be a faster, more cost effective and more comprehensive testing and characterization for the world’s blood and plasma supply chain.”
Final preparations are currently underway for field trials for the MosaiQ IH Microarray (for blood grouping), the initial MosaiQ SDS Microarray (incorporating serological diseases screening assays for Cytomegalovirus, or CMV, and Syphilis) and the MosaiQ Instrument. European field trials are expected to be completed in mid 2017 followed by the commencement of U.S. field trials in the second half of 2017.
Performance Evaluation Studies - Update
In the lead up to conducting field trials, Quotient has been regularly conducting internal performance evaluation studies to demonstrate the ongoing performance of MosaiQ™ for blood grouping (comprising both antigen typing and antibody detection) and the initial disease screening assays (CMV and Syphilis). Results using MosaiQ™ were then compared with results generated by the donor-collection laboratories providing the samples or by the Company, using predicate technologies.
Antibody Detection
Quotient has completed two studies to evaluate the performance of MosaiQ™ for antibody detection. In both studies, microarrays were used that incorporated development material representative of MosaiQ IH Microarrays that will be used in field trials. Summary results for each of the studies are set out below:
(i) 24 known positive samples, containing one or more “unexpected” blood–group antibodies, were procured from a donor collection agency. MosaiQ™ detected blood-group antibodies in all 24 samples; and
(ii) 340 “naïve” samples were procured from a donor collection agency, all of which were determined to be negative for “unexpected” blood-group antibodies by the predicate technology. In this study, MosaiQ™ proved itself to be more sensitive than the predicate, detecting antibodies in 38 of the samples analyzed. While we intend to continue to optimize the MosaiQ™ detection and interpretation algorithm, due to the sensitivity of MosaiQ™, it remains our expectation that MosaiQ™ will detect more antibodies than the predicate technology.
Antigen Typing
A summary of the performance evaluation data for antigen typing presented in early January 2017 is set out below:
| Blood Group | Specificity | Total Samples | True +ve | False +ve | True -ve | False -ve | Concord -ance (%) | Sensit -ivity (%) | Specif -icity (%) | |||
| ABO | A | 804 | 297 | 0 | 507 | 0 | 100.0 | % | 100.0 | % | 100.0 | % |
| B | 804 | 93 | 0 | 711 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | |
| Rhesus | D | 804 | 631 | 0 | 169 | 4 | 99.5 | % | 99.4 | % | 100.0 | % |
| C | 804 | 502 | 0 | 302 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | |
| c | 804 | 657 | 0 | 143 | 4 | 99.5 | % | 99.4 | % | 100.0 | % | |
| E | 804 | 264 | 0 | 540 | 0 | 100.0 | % | 100.0 | % | 100.0 | % | |
| e | 804 | 781 | 0 | 22 | 1 | 99.9 | % | 99.9 | % | 100.0 | % | |
| Kell | K | 804 | 78 | 0 | 726 | 0 | 100.0 | % | 100.0 | % | 100.0 | % |
Since the above data was generated, we have undertaken multiple studies in connection with the ongoing validation of manufacturing processes and the MosaiQ Instrument, with the results generated confirming the above results.
Initial Disease Screening Assays
Results from the previously reported performance evaluation study for the initial MosaiQ™ disease screening panel are set out below:
| Target | Total Samples | True +ve | False +ve | True -ve | False -ve | Sensit- ivity (%) | Specif- icity (%) | ||
| Syphilis | 240 | 39 | 0 | 201 | 0 | 100.0 | % | 100.0 | % |
| CMV | 183 | 87 | 0 | 93 | 3 | 96.7 | % | 100.0 | % |
Samples relating to the false negatives reported for CMV in the above evaluation study were subsequently retested using a third “tie breaker” technology, which also found the samples to be negative for CMV, thus demonstrating 100% sensitivity in the sample tested.
MosaiQ™ Manufacturing System
Final product qualification procedures for the MosaiQ™ microarray manufacturing system (comprising the three key elements: (i) the print system; (ii) the wet process; and (iii) the final assembly system) are approaching completion. The Company plans to begin to manufacture MosaiQ IH Microarrays and the initial MosaiQ SDS Microarrays for field trials in early April 2017.
MosaiQ Instrument
Development of the MosaiQ Instrument has now been completed and formal validation has commenced. Quotient expects to take delivery of the first commercially ready MosaiQ Instruments in early April 2017.
Product Development
Product development for the additional antibodies to be included on an extended MosaiQ IH Microarray is now largely complete. Transfer of these antibodies to manufacturing will commence shortly, for inclusion on the MosaiQ IH Microarray for field trials in the United States.
Development and optimization of assays for inclusion on an extended serological disease screening panel is ongoing. Quotient expects to transfer the remaining mandated serological disease screening assays to production in the second half of 2017.
During February our development partner took delivery of a MosaiQ™ device that is expected to be used to demonstrate feasibility of our novel nucleic acid testing (NAT) amplification technology. Our current NAT development work is focused on demonstrating appropriate amplification and detection of clinical samples. Quotient plans to finalize the development pathway for the molecular disease screening microarray following completion of this demonstration.
About MosaiQ™
MosaiQ™, Quotient’s next-generation automation platform for blood grouping and donor disease screening, is a transformative and highly disruptive testing platform designed to address the $3.4 billion global transfusion diagnostics market. Utilizing a single instrument platform, MosaiQ™ is designed to undertake a comprehensive characterization of donor and patient blood (i.e. blood grouping) and all mandated serological and molecular disease screening tests for donor blood. Adoption of MosaiQ™ by donor- and patient-testing laboratories is expected to deliver substantial efficiencies and material cost savings, while also improving patient outcomes.
MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms, spanning blood grouping (for donor and patient testing) and serological and molecular disease screening for donor testing.
Once approved, MosaiQ™ will be the only fully automated solution for blood grouping providing for the comprehensive characterization of donor and patient blood, with turnaround times significantly quicker than existing methods. Widespread adoption of MosaiQ™ is expected to improve patient outcomes through better and easier matching of donor and patient blood, given cost-effective extended antigen typing offered by MosaiQ™.
MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories.
Quotient expects to develop additional applications for MosaiQ™, starting with nucleic acid testing for donor molecular disease screening, upon completion of assay development for the blood grouping and serological disease screening applications.
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 donor disease screening (transfusion diagnostics), Quotient is developing its proprietary MosaiQ TM technology platform to disrupt and transform the $3.4 billion global transfusion diagnostics market. Quotient has over 30 years of experience developing, manufacturing and commercializing transfusion diagnostic products. The company’s operations are based in Switzerland, Scotland and the US.
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 and the development, regulatory approval, commercialization and impact of MosaiQ TM . 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 — chris.lindop@Quotientbd.com; +41 (0)799 61 69 38
