SQI maintains an EUA (FDA) pathway for its highly quantitative and highly relevant Covid-19 Antibody test.
SQI Diagnostics adjusts to FDA shift from at-home tests
2021-10-19 18:23 ET - News Release
Mr. Andrew Morris reports
SQI DIAGNOSTICS INC. RESPONDS TO CHANGE IN FDA PRIORITIES IN EMERGENCY USE AUTHORIZATION
SQI Diagnostics Inc. has responded to a recent shift in U.S. 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 deprioritize 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 chief executive officer of SQI Diagnostics. "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 Inc.
SQI Diagnostics is a life science and diagnostic 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.