Decision Diagnostics Corp (DECN)

[rawman]

The link to the FDA EUA approved application list was posted to this Board yesterday (3/27). The "official" list included the 18 companies, which had been given the EUA fast track exemption through THURSDAY, MARCH 26, 2020.

That list was last updated 3.23. Thats an old list.

For future reference, the FDA-approved EUA list is updated every single business day. Friday's approvals will be on the list come Monday, March 30. If any new South Korean companies were added on the 27th, they will show up on Monday. If a serological test procedure is not listed, DECN does not yet have an EUA exemption. DECN is certainly not part of the earlier mentioned Korean manufacturers' with approval, as these three companies all focus on assaying DNA, via nose and/or throat fluid samples.

Since DECN does not attempt to identify the SARS-CoV2 DNA, it is fairly certain DECN will not be on the Monday list or Tuesday list or the Wednesday list or...whenever list, anytime soon. DNA focused tests are the only protocols that have thus far been approved by the FDA. It appears the FDA is reticent to review blood-borne antibody tests and FDA is certainly not motivated to spend a lot of time analyzing and understanding "impedance", which is a completely new technological approach coming from DECN. By its absence, per the FDA EUA Guidelines, impedance is not a recognized serological test protocol. Impedance requires a special FDA exemption. The only "approved" blood test modality is covered in SECTION D of the FDA EUA Guidelines. At this point the FDA is going with the "known", rather than the "what might be"! Analyzing exceptions to the Guidelines takes too much time and the FDA already has too little time.

Rest assured, there are x-number of serological tests that would be in front of DECN in the review queue. As of just few days ago, DECN did not even have finalized controlled study test data to submit along with its EUA application.