the FDA gave a warning about the Innova test on June 10th
"The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law."
https://www.fda.gov/medical-devices...pid-qualitative-test-fda-safety-communication
so its taken 5 months since then to put out a stop use notice.
could be good timing for Anteotech, we know we are currently in the final stage 3 of DHSC testing. b/w 4000-5000 tests which Derek said wouldn't be finished till the new year. seeing UK cases are increasing that should help with testing numbers.
just one of the trials ADO are working thru.
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- Innova tests’ bad results headed for the bin.
Innova tests’ bad results headed for the bin., page-40
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