Thanks for the link.
- Still working on testing protocols with FDA for US testing.
- Focus on CE Mark approval for overseas distribution
- Still mentions both blood and saliva kits (interesting)
- Hoping for CE Mark approval by end of September
While continuing to state that DECN has a test and a test that "works", no clear statement on when US testing will occur as they continue to work with FDA on protocols for testing. Given the history of that statement going back at least to May if not before, that may very well mean DECN's opinion that the FDA must lower the testing requirements regarding sensitivity in order for DECN's blood test kit to be able to get EUA approval.
Given the company continues to state that testing is now ongoing in South Korea, they must have a pretty clear sense of what the data is showing regarding sensitivity and specificity. While they have made statements regarding specificity (meeting or exceeding FDA guidelines), they have been mute on any sensitivity.
However, the company has issued more than one PR giving their "opinion" on the need for FDA to lower the requirements of rapid tests.
Therefore, as others have expressed, it appears that DECN's testing of their kits (blood and saliva) may not meet the current FDA sensitivity requirements. If all their testing showed that the kits did meet those requirements, it should be headline news for the company to release and brag about.
In the interview, the PR man for DECN mentions that they hope for CE Mark approval as foreign standards are lower than the US FDA requirements.
Now, that may be enough for the company to get the legs it needs, but at this point, unless the FDA changes their standards, it doesn't look promising to expect FDA approval of either kit given the time, testing and statements in this interview.
