SQI Diagnostics Inc., a Toronto, Canada-based precision medicine company, announced that FDA will not continue its review of SQI’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 agency 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. The FDA has encouraged SQI to submit an application under a non-EUA regulatory pathway.
“This decision is disappointing for SQI,” says Clive Beddoe, Interim CEO. “We were encouraged by the positive dialogue with the FDA throughout the review process, and we will continue with our efforts to seek FDA regulatory clearance for this product in the US. 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. We are confident that the FDA prioritization will support our upcoming COVID-19 Home Antibody Test submission under the EUA regulatory pathway.”