SQI Diagnostics, a Canada-based respiratory health and precision medicine tests provider, has secured the Interim Order authorisation from Health Canada for its new severity triage test.
The new test, dubbed Rapid Acute Lung Injury Diagnostic (RALI-Dx) is an interleukin-6 (IL-6) diagnostic test that provides results within one hour.
RALI-Dx works by checking for the presence of the bio-marker IL-6 to identify patients who are at high risk of severe inflammatory response from cytokine storms.
The severity triage test is the first IL-6 diagnostic test approved in Canada and will play a crucial role in detecting the patient risk associated with Covid-19, said the company.
SQI Diagnostics president and CEO Andrew Morris said: “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.
“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 biomarker utility, which forms the basis for the RALI-Dx test, was discovered by a team of physicians at the University Health Network (UHN).
SQI Diagnostics, a company that develops and manufactures respiratory health and precision medicine tests, later developed the biomarkers into a fast turn-around test.
The company conducted clinical studies at three global sites, in Canada, the US, and Brazil, to validate the performance of RALI-Dx in real-world, emergency room settings.
The clinical study was partly supported by the Rapid Research Funding Opportunity at the Canadian Institutes of Health Research (CIHR), by granting two funding awards to UHN.
UHN chief of innovation Shaf Keshavjee said: “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?
“Diagnostic tools like RALI-Dx help to address that gap and give us the insights we need to successfully manage the ongoing Covid pandemic.”
