SQI Diagnostics Says EUA Submission Acceptable For Its Three COVID Diagnostic Tests
(RTTNews) - SQI Diagnostics Inc.(SQD.V, SQIDF), a Canadian precision medicine company that develops rapid diagnostic testing, on Monday announced confirmation from the U.S. FDA that Emergency Use Authorization or EUA submission is acceptable for its three novel COVID diagnostic tests.
SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI-fast Severity Triage Point-of-Care or POC Test.
SQI's RALI-dx COVID-19 Severity Triage Test measures five critical biomarkers including IL-6 in approximately 50-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not.
SQI's RALI-fast COVID-19 Severity Triage POC Test measures the key critical biomarker IL-6 in approximately 15-minutes.
SQI's COVID-19 HOME Antibody Test identifies the presence of IgM, IgA and IgG antibodies of SARS-CoV-2 in individuals suspected to have been infected with COVID-19 and those wanting to know if they have been exposed.
SQI intends to submit RALI-dx for EUA to FDA in late fourth quarter, 2020, RALI-fast for EUA in late Q1 2021, and COVID-19 HOME Antibody Test for EUA in early Q1 2021.
Upon FDA approval, the RALI-dx COVID-19 Severity Triage Test could be used primarily in hospital emergency departments, while RALI-fast COVID-19 Severity Triage POC Test could be used primarily in hospital emergency departments and urgent care centers.
The COVID-19 HOME Antibody Test is expected to be used widely, including by school systems, businesses, sports teams, government and consumers at home.
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