RE:Is Antibody Rapid Test Still Eligible for EUA/ UPHNHi ResearchGuy,
You must have had your intuitive antenae working earlier this morning/last night because SQD issued news on that very topic this afternoon; what follows is the first few paragraphs:
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."