SQI Diagnostics Inc. announced it has received Health Canada Interim Order authorization for its Rapid Acute Lung Injury Diagnostic (RALI-Dx(TM)) IL-6 Severity Triage Test. RALI-Dx(TM) is the first interleukin-6 (IL-6) diagnostic test approved in Canada, and its turnaround time of less than an hour is developed to fill an important and unmet public health need. The Severity Triage test is intended to play a vital role in clarifying COVID-19 patient risk.

By testing for the presence of the key bio-marker IL-6, RALI-Dx(TM) it helps identify which patients are most at risk of a severe inflammatory response from cytokine storms, which is associated with the worst patient outcomes. The biomarker utility that is the foundation of the test was discovered by a team of physicians at UHN, which was then developed by SQI Diagnostics into a fast turn-around test. Clinical studies were conducted at three global sites (Canada, US, and Brazil) to determine how well RALI-Dx(TM) performs in real world, emergency room settings.

The combined cohort from all countries included 256 subjects. There were no statistical differences between the country cohorts, which illustrates the universality of the device. The clinical study was partly funded by the Rapid Research Funding Opportunity at the Canadian Institutes of Health Research (CIHR).

CIHR granted two awards to UHN totaling $1,020,702 to support the study in March 2020. The study was led by UHN and the team's findings were recently published in the European Respiratory Journal.