TORONTO, Oct. 19, 2021 /PRNewswire/ - SQI Diagnostics Inc. ("SQI" or the "Company") (TSXV: SQD) (OTCQB: SQIDF), a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, today responded to a recent shift in US Food and Drug Administration (FDA) priorities around Emergency Use Authorization (EUA).
The FDA has announced that, because the COVID-19 pandemic has moved into a new phase with respect to testing, it is no longer prioritizing the review of at-home testing and home sample collection for COVID-19 antibody tests under EUA.
This shift will de-prioritize the review of all these devices already submitted for FDA consideration. However, because SQI had not yet submitted its EUA application it is now able to move from a patient self-collection model to one in which a trained medical professional will collect a whole blood sample.
"As we have seen throughout the pandemic, changing government and regulatory priorities in the face of new or evolving circumstances is to be expected," said Andrew Morris, President and CEO of SQI Diagnostics Inc. "SQI is in the fortunate position of being able to pivot our ongoing clinical validation study to meet the new priorities of the FDA for EUA review."
SQI plans to pursue a modified intended-use claim that fits with the FDA's current emphasis of convenient testing and meeting the public health need.
SQI believes that its collection of fingerstick capillary samples by trained medical professions would offer a pain-free sample collection option for a quantitative COVID-19 antibody test that is convenient for patients. SQI's approach would make rapid and accurate testing more available in places where people are already accessing COVID-19 testing such as drive-through clinics, pharmacies, the workplace and other institutional settings.
About SQI Diagnostics
SQI Diagnostics is a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics. The Company's proprietary microarray tests and fully automated systems are designed to simplify protein and antibody testing workflow, increase throughput, reduce costs and provide excellent data quality. For more information, please visit www.sqidiagnostics.com.
Chief Financial Officer
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SOURCE SQI Diagnostics Inc.