Decision Diagnostics Corp (DECN)

[Raffis]

“The design above makes use of a virus antigen approach favored by some of the competitive companies in the Covid-19 testing field, but, as it turns out, not a favorite method at the FDA which favors PCR, a 35+ year old standard. The major difference (magic) is that the approach used by the company in its GenViro! product allows for swift (10.5 seconds or less) results using a minimum of blood from a finger prick, or an equally small amount of saliva from a human subject. All work commenced on the product specification chosen by Mr. Berman with components such as the platinum electrodes, platinum carbon paste, industrial films (several types) to make the biosensor, and perhaps a new impedance chip for the meter. Prototypes of the test strip and the metering device were employed and test strips for investigational testing were delivered to the company on August 2, 2020. Additional test strips in somewhat larger quantity will be delivered on or about August 24. The company is in the process of finalizing a clinical testing agreement with a potential partner, an east coast based testing lab with their own previously authorized Covid-19 test. The parties are working toward a clinical start date of September 1, 2020.

For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company first filed an application for its Professional use version of its GenViro! Covid-19 test kit on April 3. We received PEUA designation from the FDA on April 4. Conversations with FDA review staff began in earnest on April 14. This application was for the point of care testing of blood from human subjects. The company then filed a second EUA application with the FDA on May 1. This application was for our individual use GenViro! test kits. We received PEUA designation from the FDA on May 2. Further, the company plans to file a third EUA application for its GenViro! saliva based method, but this time will hold off on the application until the testing trials are complete and file the application along with the data.

The specifications guidelines set down by Mr. Berman, for creating this Covid-19 testing device and its important chemistry, were that the test must be measured on the company’s existing Precise or Avantage glucometer mold, along with changes to the electronics in the meter, and the differences in test strip size and configuration, to reflect the higher powered electrodes required for virus detection using small (fingertip) samples of whole blood. Later, and just recently the company also added testing using saliva to its kits. In addition, the resulting chemistry would necessarily run using a patients (small sample of) whole blood taken from a finger prick, or saliva taken from a capture tube, found in advanced testing to be 1-2 microliters of fluid (a small drop on a finger tip for blood, and a small amount in a saliva capture cylinder), to perform the test and provide a result in one minute or less (later redefined in two iterations to its current 10.5 seconds or less), with at least a 95% accuracy (the newest FDA guidelines). It should be noted that the company’s virus detection methodology for human saliva which makes use of all of the components in the original GenViro! chemistry (test strip) itself as well as the meter. Three alternative designs were provided and given to the company on March 2. Two of the designs were diagrammed by Mathew Musho, PhD (see below), the third design by a chemist and engineer from The Bio in Korea. The chosen of the three alternative product designs beared the trade name GenViro! Swift.”
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