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SQI Diagnostics : FDA Stops EUA Review Of RALI-Dx IL-6 Severity Triage Test For COVID-19 Patients

SQI Diagnostics Inc.(SQD.V, SQIDF), a Canadian precision medicine company that develops rapid diagnostic testing, said that U.S. Food and Drug Administration will not continue its review of the company's submission of the RALI-Dx IL-6 Severity Triage Test for Emergency Use Authorization under the "Tests for Management of COVID-19 Patients" category.

The FDA cites a high volume of EUA requests and its prioritization of EUA reviews according to factors including the public health need for the product and shortages of critical devices during the pandemic.

However, the FDA has asked SQI to submit an application under a non-EUA regulatory pathway.

The RALI-Dx IL-6 Severity Triage Test has broad applicability in helping to identify patients with severe inflammatory response arising from COVID-19 and other causes of respiratory distress.

SQI said it is confident that the FDA prioritization will support its upcoming COVID-19 HOME Antibody Test submission under the EUA regulatory pathway.

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