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

Rhea-AI Summary

SQI Diagnostics Inc. (TSXV: SQD) (OTCQB: SQIDF) has received Health Canada Interim Order authorization for its RALI-Dx™ IL-6 Severity Triage Test, marking it as Canada's first IL-6 diagnostic test. This test, with a turnaround time of under an hour, aims to address severe respiratory issues, particularly in COVID-19 patients. Developed in collaboration with University Health Network, the test identifies patients at risk of severe inflammatory responses, potentially improving hospital care efficiency. Clinical studies involved 256 subjects across Canada, the US, and Brazil, and were funded by the Canadian Institutes of Health Research.

Positive

• RALI-Dx™ is the first IL-6 diagnostic test approved in Canada.
• Turnaround time for the RALI-Dx™ test is less than one hour.
• The test addresses a critical public health need, potentially improving survival rates for COVID-19 patients.
• Clinical studies demonstrated the test's performance across multiple countries without statistical differences.

Negative

• None.

TORONTO, Oct. 17, 2022 /PRNewswire/ - SQI Diagnostics Inc. (TSXV: SQD) (OTCQB: SQIDF), 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^™ it helps identify which patients are most at risk of a severe inflammatory response from cytokine storms, which is 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 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 MD, Surgeon-in-Chief 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, which illustrates 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.

About SQI Diagnostics

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 is developing tests to simplify and improve COVID-19 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.

FORWARD-LOOKING INFORMATION

This press release contains certain words and statements, which may constitute "forward-looking statements" within the meaning of applicable securities laws relating to future events or future performance and reflect the current expectations and assumptions of the Company regarding its growth, results of operations, performance, business prospects and opportunities. These statements generally can be identified by use of forward-looking words such as "may", "would", "could", "will", "should", "expect", "plan", "estimate", "anticipate", "intends", "believe", "potential", or "continue" or the negative thereof or similar variations. The Company's actual results and performance discussed herein could differ materially from those expressed or implied by such statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations. Important factors that could cause actual results to differ materially from expectations include, among other things, general economic and market factors, competition, the effect of the global pandemic and consequent economic disruption, and the factors detailed in the Company's ongoing filings with the securities regulatory authorities, available at www.sedar.com. Although the forward-looking statements contained herein are based on what we consider to be reasonable assumptions based on information currently available to us, there can be no assurance that actual events, performance or results will be consistent with these forward looking statements, and our assumptions may prove to be incorrect. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable law.

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SOURCE SQI Diagnostics Inc.

FAQ

What is the RALI-Dx™ IL-6 Severity Triage Test approved by SQI Diagnostics?

The RALI-Dx™ IL-6 Severity Triage Test is a diagnostic tool approved in Canada that identifies patients at risk of severe inflammatory responses, especially in COVID-19 cases.

When did SQI Diagnostics announce the approval of RALI-Dx™?

SQI Diagnostics announced the Health Canada approval of RALI-Dx™ on October 17, 2022.

How does RALI-Dx™ help in managing COVID-19 patients?

RALI-Dx™ tests for the biomarker IL-6 to determine which COVID-19 patients are at increased risk for severe outcomes, aiding emergency room doctors in patient management.

Where were the clinical studies for RALI-Dx™ conducted?

Clinical studies for RALI-Dx™ were conducted in Canada, the US, and Brazil.

What funding supported the clinical study of RALI-Dx™?

The study was partly funded by the Canadian Institutes of Health Research (CIHR), which awarded $1,020,702 to support the research.