Therapy Areas: Devices
US FDA Stops Emergency Use Authorization Review of SQI Diagnostics RALI-Dx IL-6 Severity Triage Test for COVID-19 Patients
26 July 2021 - - The US FDA will not continue its review of Canada-based rapid diagnostic testing developer SQI Diagnostics Inc's (TSX Venture: SQD) (OTCQB: SQIDF) 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 company said.

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.

SQI Diagnostics is a life sciences and diagnostics company.
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