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

SQI Diagnostics Inc., 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.