IL-6 Severity Triage Test Identifies Severe Inflammatory Response in Patients with Confirmed COVID-19 Illness

SQI Diagnostics, Inc. (Toronto, ON, Canada) has submitted its fully completed clinical and analytical data package to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of its RALI-Dx IL-6 Severity Triage Test. 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.

The RALI-Dx IL-6 Severity Triage Test helps 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. The test measures 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.

"Our priority is to help address this global health emergency," said 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."

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SQI Diagnostics, Inc.