Four Diagnostic Products in the Pipeline at SQI

TORONTO, March 3, 2023 /CNW/ - SQI Diagnostics Inc. (TSX-V: SQD) (OTCQB: SQIDF), a leader in the science of lung health that develops and manufactures respiratory health and precision medicine tests, today 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™ IL-6 Severity Triage Test, TORdx™ LUNG, and RALI-fast™ IL-6 Severity Triage POC Test, as well as a preliminary study of Owlstone Medical's Breathe Biopsy platform.

"At UHN, we are proud to be the home for some of the most groundbreaking work in lung transplantation. We have been working with SQI Diagnostics for more than five years on a number of projects in respiratory health," said Dr. Brad Wouters, Executive Vice President, Science and Research, University Health Network. "Our collaboration with SQI is an example of industry partnerships that work effectively to help clinicians and surgeons improve the number and quality of lungs potentially available for transplant."

Here is what SQI is working on:

1. RALI-Dx Triage Test Clinical Evaluation

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 RALI-Dx at hospitals.

"As the leading research commercialization hospital in Canada, the University Health Network frequently acts as an incubator for the development of medical technologies, which can include evaluating industry medical products for viability of future clinical use. Our ongoing partnership with SQI includes the investigation of RALI-Dx for wider use, "said Mark Taylor, Director, Commercialization at UHN. "We continue to work closely with them to further validate the impact of RALI-Dx in respiratory care."

2. TORdx™ LUNG Transplant Clinical Study

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™ LUNG use to aid in lung transplant decision making in the US market. The proposed TORdx™ LUNG clinical study is an important step in bringing to market SQI's TORdx™ LUNG 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.

"Our co-development partnership is intended to significantly increase the number of lung transplants performed, and thus positively impacts the many patients currently stuck on the transplant waiting list," said Dr. Shaf Keshavjee, MD, Chief of Innovation at UHN.

3) RALI-fast Clinical Evaluation

In North America, up to 40 per cent 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.

"RALI-fast is intended to help me more closely monitor the ICU patient inflammation status at the molecular level. This test has the potential to provide insights when the patient care can be de-intensified or when patient care needs to be escalated," said Dr. Lorenzo del Sorbo, Director of Research at the Toronto General Hospital Medical Surgical Intensive Care Unit (MS-ICU) at UHN, and Assistant Professor, Department of Medicine/Critical Care Medicine, Temerty Faculty of Medicine at the University of Toronto.

4) Fungal Infection Breathe Study

SQI has also begun a preliminary clinical study of non-invasive breath diagnostic technology for the early and accurate detection of organ rejection. This would help to confirm the use model and biomarker validity in the diagnosis of aspergillosis in post-lung transplant patients.

Fungal lung infection is a large risk for people like transplant patients, whose one-year survival rates for invasive aspergillosis following lung transplant is only 59 per cent. Because antifungal therapies are not appropriate for patients who are on immunosuppressants, early and reliable diagnosis of fungal infection is critical. Right now, the best available diagnostic procedures for lung transplant rejection require the regular collection of tissue samples from the lung, which is invasive, expensive and can lead to serious complications. Owlstone Medical's non-invasive Breathe Biopsy platform represents a better approach which, alongside SQI's deep experience in lung transplant diagnostics, will be used to identify and deploy novel breath-based biomarkers that can detect early rejection of organs in lung transplant patients.

"With UHN's strategic interest in lung transplant biomarkers, we're excited to collaborate with UHN and Owlstone in applying the discovery, development and commercialisation of biomarkers of fungal infection," said Andrew Morris, President and CEO of SQI Diagnostics. "An extended partnership with UHN and Owlstone can help further establish SQI's leadership in commercialising diagnostic testing for healthcare professionals and patients as we extend SQI's diagnostics across the continuum of care for organ transplant patients."

The RALI-Dx™ IL-6 Severity Triage Test and the RALI-fast™ IL-6 Severity Triage POC Test each help clinicians identify which patients with SARS-CoV-2 will have a severe inflammatory response and should be admitted to the hospital to help determine the risk of intubation with mechanical ventilation. Both tests measure the critical biomarker IL-6 which plays a key role in the cytokine storm phase of COVID-19.

The RALI-Dx™ IL-6 Severity Triage Test delivers results from the lab in about 60 minutes while the RALI-fast™ IL-6 Severity Triage POC test that is currently in development, delivers results at the patient point-of-care in about 15 minutes.

Only 20-25 per cent of the available donor lungs are deemed suitable by surgeons for transplant to the recipient. This donor lung scarcity means patients face long wait times, potential deterioration while on the wait list, and complications post-transplant because the patient was not as healthy because of long wait times for donor lungs.

Transplant surgeons are concerned about damage and trauma to the lung – damage that is visible, and damage, primarily inflammation, which is at the molecular level. A lack of quantitative and objective decision-making tools about lung damage – especially at the molecular level, where inflammation is a grave concern — lead many donor lungs to be rejected for transplant.

New technologies have been adopted where donor lungs are placed on a system called Ex Vivo Lung Perfusion (EVLP) before transplanting to the recipient. EVLP allows the transplant team to quantitatively assess the lung's oxygenation capability before transplant. However, even with EVLP, until now there has been no precision medicine measurements to measure inflammation of the donor lungs within viable time frames.

SQI Diagnostics' TORdx™ LUNG Test measures up to four inflammation biomarkers in a series of samples drawn from the EVLP circuit. In 2018, SQI Diagnostics began collaborating with Dr. Shaf Keshavjee, who is Chief of Innovation at Toronto's University Health Network (UHN) and a global leader in lung transplantation.

SQI Diagnostics is a leader in the science of lung health. The Company develops and manufactures respiratory health and precision medicine tests that run on SQI's fully automated systems. The Company's tests simplify and improve COVID19 antibody monitoring, Rapid Acute Lung Injury testing, donor organ transplant informatics, and immunological protein and antibody testing. SQI Diagnostics is driven to create and market life-saving testing technologies that help more people in more places live longer, healthier lives. For more information, please visit www.sqidiagnostics.com.

Chief Financial Officer
Morlan Reddock
416.674.9500 ext. 277
mreddock@sqidiagnostics.com

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