Revive provides update from FDA meeting for Long COVID diagnostic product

Revive Therapeutics announced an update on the meeting written responses received by the Company from the U.S. Food & Drug Administration, FDA, of the Revive LC POC Lateral Flow Test Kit for feedback on the classification, development and regulatory submission strategy for a point-of-care in vitro diagnostic device that aids in the detection of post COVID-19 conditions. The FDA has determined that the Product should follow the De Novo regulatory pathway, and the Company would be required to conduct a clinical study for the De Novo submission for possible approval. “We agree with the FDA feedback and with their recommendations that provides a pathway for the development of the Revive LC POC Lateral Flow Test Kit in the detection of long COVID,” said Michael Frank, CEO of Revive. “We will now discuss the proposed development plan and timelines with potential contract manufacturers.”