- Root-cause investigation completed and corrective actions implemented
- Performance evaluation study for antigen typing achieves targeted endpoints
- Completion of European field trials expected in the first half of 2017
JERSEY, Channel Islands, Jan. 05, 2017 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported positive results from its MosaiQ™ performance evaluation study for antigen typing. The Company continues to expect European field trials for MosaiQ™, for blood grouping and the initial disease screening panel, to be completed during the first half of 2017.
“We believe the positive results from the performance evaluation study demonstrate the power and potential of MosaiQ™. Prior to commencing the study, we successfully completed the root-cause investigation previously announced and implemented all necessary corrective actions,” said Paul Cowan, Chairman and Chief Executive Officer of Quotient. “Results from the performance evaluation study demonstrate our confidence in being able to transfer existing blood grouping tests to the MosaiQ™ platform and that the MosaiQ™ instrument is robust.”
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.
Antigen Typing Performance Evaluation Study - Results
Microarrays incorporating assays to identify ABO, Rhesus and Kell blood-group antigens were used in the performance evaluation study. Below is a summary of the results.
| Blood Group | Specificity | Total Samples | True Positive | False Positive | True Negative | False Negative | Concordance (%) | Sensitivity (%) | Specificity (%) | ||||||||||||||||||||||
| 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 | % | |||||||||||||||||||
Microarrays used in the study were manufactured at the Company’s Eysins, Switzerland facility (printing, wet process and final assembly), with microarrays from multiple production lots being used. Samples were acquired from donor-collection agencies and processed using MosaiQ™ instruments incorporating final hardware and the latest version of the instrument software. Results using MosaiQ™ were compared with results generated by the donor-collection laboratories providing the samples - using predicate technologies (i.e., the Beckman Coulter PK7300 or manual testing).
Performance evaluation studies for antibody screening/identification and the initial disease screening panel (to screen for CMV and Syphilis) are underway.
MosaiQ™ - Serological Disease Screening Panel
Activities with the Company’s development partner for the full serological disease screening panel have achieved their targeted milestones, prior to final internal development studies and optimization using microarrays manufactured at the Eysins, Switzerland facility and MosaiQ™ instruments.
About MosaiQ™
MosaiQ™ has been designed to offer a breadth of diagnostic tests unmatched by existing commercially available transfusion diagnostic instrument platforms, spanning blood grouping, serological disease screening for donor testing and nucleic acid testing (or molecular disease screening) for donor testing.
Once approved, MosaiQ™ will be the first 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™. Improved patient outcomes from the use of MosaiQ™ include the potential for reduced incidence of adverse events associated with transfusion, including alloimmunization where patients develop antibodies to foreign antigens introduced through transfused blood.
MosaiQ™ will also offer the opportunity for substantial cost savings and a range of operational efficiencies for donor and patient testing laboratories, including:
- elimination of the need for expensive, routine manual testing typically undertaken by highly skilled technicians;
- simplification of required consumables and testing processes;
- consolidation of multiple instrument platforms in donor testing laboratories;
- significant reduction in sample volume requirements;
- significant reduction in waste, including the number and volume of patient/donor samples required, consumables and reagent waste; and
- more streamlined processes for matching donor units to patients.
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 serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to address the $3.4 billion global transfusion diagnostics market. 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 MosaiQTM. 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.