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SQI Diagnostics Announces Health Canada Approval of RALI-Dx Severity Triage Test

Tuesday, October 18, 2022

SQI Diagnostics Inc., a leader in the science of lung health that develops and manufactures respiratory health and precision medicine tests, today announced it has received Health Canada Interim Order authorization for its Rapid Acute Lung Injury Diagnostic (RALI-Dx™) IL-6 Severity Triage Test. RALI-Dx™ 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.

"COVID continues to strain our health care system, continues to spawn new variants and continues to be a challenge as new waves continue to form," said Andrew Morris, President, and CEO of SQI Diagnostics. "We believe RALI-Dx™ will be an important tool in the hands of Emergency Room doctors to help raise survival rates for the most seriously ill COVID patients while also improving the efficiency and efficacy of hospital care. We also hope to investigate its potential use in other severe respiratory health conditions."

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™ helps to identify which patients are most at risk of a severe inflammatory response from cytokine storms associated with the worst patient outcomes.

"The health care system continues to be plagued by a major gap — when patients present with respiratory symptoms, how can we determine, at an early stage, which people might progress to critical illness or death and need hospitalization, and which people can be safely discharged into at-home monitoring?" said Dr. Shaf Keshavjee, Chief of Innovation at University Health Network (UHN). "Diagnostic tools like RALI-Dx™ help to address that gap and give us the insights we need to successfully manage the ongoing COVID pandemic."

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™ 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 illustrating 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 totalling $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.

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