- 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 | % |