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Revive Therapeutics Announced FDA Acceptance of Meeting Request for Long COVID Diagnostic Product
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Revive Therapeutics Announced FDA Acceptance of Meeting Request for Long COVID Diagnostic Product
Apr 18, 2024 5:19 AM

07:57 AM EDT, 04/18/2024 (MT Newswires) -- Revive Therapeutics ( RVVTF ) , a specialty life sciences company, on Thursday announced that the U.S. Food and Drug Administration has assigned it a meeting date of June 7. Revive had requested a meeting to discuss its Point of Care Lateral Flow Test Kit for feedback on strategy for the device that aids in the detection of post COVID-19 conditions. Its subsidiary Revive Diagnostics, is advancing the product as a potential blood biomarker diagnostic test.

The discovery of the biomarkers used in the kit was identified by a research team at Lawson Health Research Institute, led by Dr. Douglas Fraser, and was recently published in the journal, Molecular Medicine. Revive has an agreement with Lawson Health for the worldwide exclusive rights to the intellectual property of novel blood biomarkers that characterize long COVID.

There is no FDA-approved clinical diagnosis of long COVID, which is estimated to occur in at least 10% of severe SARS-CoV-2 infections.

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