Decision Diagnostics Corp (DECN)

[HFM2]

Even if this device shows promise, I would bet anything the FDA does not grant an EAU on 30 samples

"In the absence of known positive samples available for testing, you should confirm the performance of your assay with a series of contrived clinical specimens by testing a minimum of 30 contrived reactive specimens and 30 non-reactive specimens in a randomized blinded fashion."

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd (Test Kit Manufacturer: EUA Template (Updated March 12, 2020))

"Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus."

https://www.propublica.org/article/coronavirus-tests-are-being-fast-tracked-by-the-fda-but-its-unclear-how-accurate-they-are