FDA cites de-prioritisation due to high volume of EUA reviews; recommends other approval pathway for this test
FDA stops Emergency Use Authorisation Review of SQI Diagnostics RALI-Dx IL-6 Severity Triage Test for Covid-19 Patients. (Credit: fernando zhiminaicela from Pixabay)
SQI Diagnostics Inc. (the “Company” or “SQI”) (TSXV: SQD) (OTCQB: SQIDF), a precision medicine company that discovers, develops and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, announces 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,” stated Mr. 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.”
SQI Diagnostics is a life sciences and diagnostics company that is leading the way in healthcare utilizing state-of-the-art technology to rapidly diagnose, triage and provide medical insights to patients. We strive to improve people’s lives and assist their healthcare providers by providing quality clinical health information backed by years of research and clinical data.
Source: Company Press Release