SQI Diagnostics Submits RALI-Dx™ IL-6 Severity Triage Test for COVID-19 Patients to FDA for Emergency Use Authorization

Rhea-AI Summary

SQI Diagnostics Inc. (SQIDF) has submitted data to the FDA for emergency use authorization of its RALI-Dx™ IL-6 Severity Triage Test, aimed at identifying severe inflammatory responses in COVID-19 patients. Completed on March 31, 2021, this test is designed for use in hospital emergency departments to assess intubation risks. CEO Robert L. Chioini emphasized the test's potential in managing COVID-19 care. The company is also developing a COVID-19 HOME Antibody Test and collaborating with UHN Hospitals for organ transplant diagnostics.

Positive

• Completion of FDA submission for the RALI-Dx™ IL-6 Severity Triage Test on March 31, 2021.
• Test aims to assist in identifying severe COVID-19 cases, potentially improving patient outcomes.
• Development of a COVID-19 HOME Antibody Test expected in Q2 2021.

Negative

• No assurances of receiving EUA acceptance for the RALI-Dx™ IL-6 Severity Triage Test.
• Regulatory approval for tests is subject to various risks and uncertainties.

Test Designed to Assist in Identifying Severe Inflammatory Response in Patients with Confirmed COVID-19 Illness

TORONTO, April 1, 2021 /PRNewswire/ - SQI Diagnostics Inc. (the "Company" or "SQI") (TSXV: SQD) (OTCQB: SQIDF), a precision medicine company that discovers, develops and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, announces that it has submitted its fully completed clinical and analytical data package to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of its RALI-Dx^™ IL-6 Severity Triage Test. The submission was completed on March 31, 2021. The FDA will review the application under its pre-emergency use authorization (PEUA) process before a definitive EUA review. Subject to the acceptance of an EUA, the RALI-Dx^™ IL-6 Severity Triage Test is intended to be utilized by hospital emergency departments and labs to assist clinicians in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation.

"Our priority is to help address this global health emergency", stated Mr. Robert L. Chioini, CEO of SQI. "The development and advancement of a test to help identify and determine which COVID-19 patients are at risk of a severe adverse respiratory event is one of our highest priorities in helping combat this expanding health emergency. We think the RALI-Dx^™ IL-6 Severity Triage Test is an important risk assessment tool that can help manage the care of hospitalized COVID-19 patients and the overflow of hospital admissions."

About SQI Diagnostics

SQI Diagnostics Inc. is a precision medicine company that discovers, develops, and commercializes innovative rapid diagnostic testing for healthcare providers, patients, and consumers worldwide. The Company's proprietary advanced diagnostics target organ transplant, autoimmune disease and COVID-19 testing which include the developmental direct-to-consumer COVID-19 HOME Antibody Test, the RALI-Dx^™ COVID-19 Severity Triage Test and the COVID-19 RALI-fast^™ Severity Triage Point-of-Care (POC) Test. SQI's rapid diagnostic tests are intended to be sold to healthcare professionals so that patients can get accurate results and fast effective treatment, and direct-to-consumers so that individuals can be empowered to improve their health outcomes from the comfort of home. 

SQI is fast-tracking the development of its COVID-19 diagnostic tests: a direct-to-consumer COVID-19 HOME Antibody Test and two COVID-19 Severity Triage Tests. The COVID-19 HOME Antibody Test identifies the semi-quantitative presence of IgM, IgA and IgG antibodies of SARS-CoV-2 in individuals who have been infected with COVID-19, individuals who have been vaccinated or asymptomatic individuals wanting to know if they have been exposed. The test is > 99% accurate with results delivered in 24-48 hours. The Company currently expects to apply to the U.S. Food and Drug Administration ("FDA") for Emergency Use Authorization ("EUA") for its COVID-19 HOME Antibody Test in the second quarter of calendar year 2021. Should the COVID-19 HOME Antibody Test receive regulatory approval, the test is expected to be available direct-to-consumer which would allow individuals to avoid travelling to a clinic or hospital to be tested for the presence of the SARS-CoV-2 antibody.

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 aid in determining 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 50 minutes while the RALI-fast^™ IL-6 Severity Triage POC test delivers results at the patient point-of-care in about 15 minutes. The Company currently expects to apply for an Interim Order with Health Canada for the RALI-Dx^™ IL-6 Severity Triage Test and an EUA with FDA for RALI-fast^™ IL-6 Severity Triage POC Test in the second quarter of calendar year 2021.

With organ transplant, SQI is pioneering the development of an advanced diagnostic test that increases the chance of successful lung transplant by assessing the health of the donor organ prior to transplant surgery. The Company's developmental TORdx^™ LUNG Test can detect inflammation at the molecular level to assess the health of the donor lung, enabling surgeons to transplant healthy lungs which otherwise would have been rejected; there is currently no other such test. SQI has partnered clinical development with the University Health Network (UHN) Hospitals, one of the largest health and medical research organizations in North America. Upon regulatory approval of the TORdx^™ LUNG Test, clinical development is planned for diagnostic tests designed to increase the chance of successful kidney and liver transplant.

For autoimmune disease testing, SQI has a direct-to-consumer Celiac Disease and a Rheumatoid Arthritis (RA) Test that enable people to screen for the diseases from the comfort of their home. The direct-to-consumer RA Test can help identify and confirm RA symptoms for timely care and treatment. The direct-to-consumer Celiac Test confirms disease and validates the effectiveness of dietary and lifestyle changes to confirm the autoimmune response is improving.

The Company is not making any express or implied claims that its products can eliminate, cure or contain COVID-19 (or SARS-2 Coronavirus) at this time. For its research and development, the Company is collaborating with UHN Hospitals, one of the largest health and medical research organizations in North America. 

There are no assurances that SQI will be successful at receiving EUA acceptance for the RALI-Dx^™ IL-6 Severity Triage Test or any of its other developmental COVID-19 related diagnostic tests.

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. Such forward-looking statements may be identified by words such as "anticipates", "plans", "proposes", "estimates", "intends", "expects", "believes", "may" and "will". The forward-looking statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties detailed in the Company's ongoing filings with the securities regulatory authorities, available to the public at www.sedar.com. The forward-looking statements in this press release include, without limitation, statements with respect to the use and allocation of the proceeds of Funding. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond the company's control, that may cause actual events or results to differ materially from the company's current expectations. Management's expectations and therefore any forward-looking statements in this press release could be affected by risks and uncertainties relating to a number of factors, including, but not limited to, the following: the development and viability the Company's COVID-19 HOME Antibody Test, its COVID-19 RALI-dx^™ Severity Triage Test and its COVID-19 RALI-fast^™ Severity Triage Point-of-Care (POC) Test, the suitability of such tests for advanced clinical testing, including human trials, the content and timing of decisions made by the FDA relating to the use and commercialization of such tests, the timing and costs involved in establishing the commercialization of the tests, the impact that the ongoing COVID-19 pandemic may have on the company's business, including the expected development, manufacturing, regulatory and commercialization timelines relating to the aforementioned COVID-19-related tests. 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 securities laws.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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SOURCE SQI Diagnostics Inc.

FAQ

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

The RALI-Dx™ IL-6 Severity Triage Test is designed to assist clinicians in identifying severe inflammatory responses in COVID-19 patients, particularly to assess intubation risks.

When did SQI Diagnostics submit its data for emergency use authorization?

SQI Diagnostics submitted its data to the FDA for emergency use authorization on March 31, 2021.

What other tests is SQI Diagnostics developing for COVID-19?

SQI Diagnostics is also developing a COVID-19 HOME Antibody Test, which is expected to be submitted for EUA in the second quarter of 2021.

What risks are associated with the RALI-Dx™ IL-6 Severity Triage Test approval?

There are no assurances that SQI Diagnostics will receive EUA acceptance for the RALI-Dx™ IL-6 Severity Triage Test or its COVID-19 related diagnostic tests, as various risks and uncertainties may impact the approval process.