Smokey1958 wrote:
Thanks, Freedom! These are the two most important points that makes this announcement on SONA so positive for Therma Bright and their AcuVid.
SNANF said the test worked well with contagious subjects but not as well with subjects whose viral load was low.
The AcuVid device exceeds the minimum requirements set out by the FDA
Our novel COVID-19 saliva test produced strong results with contagious patients when administered by professionals, but due to a combination of deteriorating market dynamics and an FDA preference for over-the-counter testing options
The ultimate goal for AcuVid is to be an over the counter option as the additional testing requested by the FDA was done by non-professionals.
....from clinical trials.gov
To establish the performance characteristics of the AcuVid COVID-19 Rapid Antigen Saliva Test in a point-of-care (POC) CLIA Waived setting with lay users (no laboratory experience) testing a participant that has self-collected a saliva specimen.
....and the most important difference!
The termination came after Sona's analysis of data from two clinical studies and consultations with the U.S. Food and Drug Administration (FDA).
Rob Fia and the Therma Bright team have been in constant conversations with the FDA throughout their application process ....and Rob has given every indication AcuVid is going to be approved. Clearly they would have pulled the plug long ago if there was any suggestion an FDA EUA wasn't likely.
There is NOTHING but positive news to be gleaned as to the impact of the SONA release on AcuVid!
GLTE ...holding patiently!!!