SQI Diagnostics Inc. announced it is developing three diagnostic products based on University Health Network (UHN) innovations and is exploring an initiative with Owlstone Medical and UHN on a fourth diagnostic product. The first three products include RALI-Dx(TM) IL-6 Severity Triage Test, TORdx(TM) LUNG, and RALI-fast(TM) IL-6everity Triage POC Test, as well as a preliminary study of Owlstone Medical's Breathe Biopsy platform. RALI-Dx has been approved under Health Canada's Interim Order for testing in COVID-19 positive patients--the first interleukin-6 (IL-6) diagnostic test of its kind approved in Canada, and that success has led to translate into positive progress towards multiple projects now in development.

UHN is currently conducting a research implementation study of RALI-Dx across an expanded patient population experiencing flu, RSV and other respiratory symptoms. A positive investigation could lead to eventual commercial adoption of RAL I-Dx at hospitals. SQI is planning on entering into clinical study agreements with UHN and three US-based lung transplant centers. This work could lead to a US FDA regulatory submission that will enable TORdx(TM) LunG use to aid in lung transplant decision making in the US market.

The proposed TORdx(TM) L UNG clinical study is an important step in bringing to market SQI'sTORdx(TM) LUN G Test, an advanced diagnostic that could increase the number of successful transplants. The test detects inflammation at the molecular level to help assess the quality of donor lungs. This study will elevate the status quo for inflammatory biomarkers to assess the quality of potential transplants.

RALI-fast Clinical Evaluation In North America, up to 40% of ICU admissions are related to respiratory issues. A 15-minute bedside test that provides an inflammatory profile of the patient (i.e., IL-6 levels) would be a valuable monitoring tool for Intensivists and other healthcare providers. To address this need, SQI Diagnostics has developed RALI-fast--a point-of-care device that rapidly analyzes IL-6 in patient plasma samples.

In proof-of-concept work, UHN has evaluated a prototype of RALI-fast with encouraging results. Formal clinical studies are needed to enable the optimization of product performance and to support regulatory filings in US and Canada.