SQI Diagnostics’ Rapid Acute Lung Injury Diagnostic (RALI-Dx) IL-6 Severity Triage Test has secured Interim Order (IO) authorisation from Health Canada.
With less than an hour of turnaround time, RALI-Dx is expected to address a key public health need.
According to the company, RALI-Dx is the first interleukin-6 (IL-6) diagnostic test authorised in Canada.
The test will focus on assessing Covid-19 patient risk by testing for the presence of bio-marker IL-6.
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.”
Additionally, the RALI-Dx Severity Triage Test will help track patients facing the risk of a severe inflammatory response from cytokine storms related to worst patient outcomes.
The biomarker utility, a key feature of the test, was discovered by University Health Network (UHN) physicians. It was later developed by SQI Diagnostics into a fast turn-around test.
UHN Innovation chief Dr Shaf Keshavjee said: “The healthcare 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 hospitalisation, 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.”
Clinical studies to assess the performance of RALI-Dx in emergency room settings were conducted in Canada, the US and Brazil with the participation of 256 subjects.