Decision Diagnostics Corp (DECN)

[goodthings]

DECN: Dream on!!!

No man or company is jealous of the test kits by the DECN company.

Once again, how simple, fast, and cheap DECN's GenViro COVID-19 Swift kits are,
they've haven't been proved by a "reliable laboratory on how accurate they work.

"They are simple, fast and affordable." "They work."
These words were only spoken by the CEO Berman without any "official proof."

The most important things are facts.

"DECN to Add 2nd Covid-19 Test Kit Using Antibody/Antigen Methodology as a Determination Test for Patients Who Previously Tested Positive for Covid-19"
(The title of the Press Release on March 25)

From May 4 the FDA's "new rules" (the accuracy of 90% sensitivity & 95% of specificity) do apply to ALL test kits: PCR tests (Molecular technology) and Non-PCR tests such as the DECN's two Swift kits.

The FDA issued 3 EUAs to Abbott:
March 18 (Molecular) - PCR
March 27 (Molecular) - PCR
April 26 (Serology lgG antibody only)

Abbott's three kits received the EUAs before May 4.

From May 4 to 15 the FDA granted 18 EUAs:

- 15 Molecular technology (PCR test)
- 1 Serology test on May 4
- 1 Antigen test on May 8: The FDA issued the first EUA to Quidel Corporation for a COVID-19 antigen test that quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.
(NASDAQ:QDEL -- Quidel Corporation, a major American manufacturer founded in 1979)

- 1 Home Collection Kit on May 15 by Everlywell Inc:
"For use by individuals to self-collect nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of SARS-COV-2 RNA that are indicated for use with the Everlywell COVID-19 Home Collection Kit."

Thanks to Abbott, the FDA will abide by the new heightened standards, which is bad news for the DECN company.

Now, some of DECN shareholders inspire people to expect the EUA by JUNE?? Why not July, August... by the end of this year??

DECN will never get EUA from the FDA. -- I did explain the reason based on facts from the DECN's PRs and the "stricter rules" of FDA on May 4, etc.

The DECN has NEVER mentioned the accuracy of"Sensitivity" in so many press releases, which is the KEY to getting EUA from the FDA.

PR on March 23: 'GenViro Screening COVID-19 Swift Kit' provides results in 15 seconds based on a small finger prick blood sample. This device can be used to screen out the 97% or 98% of those tested that are negative for COVID-19.

The DECN CEO, who has boasted about all sorts of things on the COVID-19 Swift Kits, has never mentioned the accuracy of "Sensitivity."

PR on March 25: Today, DECN announces the 2nd COVID-19 test kit for those who previously tested positive for COVID-19. It will produce confirmatory results in less than a minute, also based on a small finger prick blood sample. This device is for at-home use and will confirm or not confirm a positive result.

- Is it all-or-nothing?
- To get the EUA, every test needs both "sensitivity and specificity."
- To get the EUA, the Swift Kits by DECN must meet both 90% sensitivity & 95% specificity.


GenViro COVID-19 Swift kits can't save people'lives.