REMEMBER…Just two days ago! Bullets from the NR… Not pumping just exited :).
1- AcuVid™ COVID-19 Rapid Antigen Saliva Test for Point of Care (PoC) has successfully exceeded U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) requirements for both Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
2- This achievement places Therma Bright in a very unique leadership position as the first company in the COVID-19 diagnostic testing space to successfully complete a 15-minute rapid antigen saliva-based U.S. study.
3- The AcuVid™ saliva test also achieved successful results on several mouth-based bacteria and viruses in additional cross-reactivity study requests from the FDA, which other EUA test manufacturers did not have to conduct.
4- It’s our belief we have achieved all requests and requirements, and have one of the most tested pre-EUA COVID-19 rapid antigen tests for submission. Once our final FDA EUA application for Point-of Care is complete, we will submit and patiently await authorization.”
5- Furthermore, and as stated in prior releases, the Company has BEGAN WORK on its FDA EUA efforts for AcuVid™ At Home Use, and continues to work with its valued partners to improve the performance of its rapid antigen saliva test for this self-test submission.