livefree_ordie - Annual Report "Supplemental", p. 16 - may help?
They list "The Bio Co., LTD" in Daegu, South Korea at their contract manufacturing partner, and I believe also R&D facility.
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 glucometers, because they were completed products, having been tested to great length, and now to be adapted for detection of Covid-19 instead of whole blood glucose. In addition, the resulting chemistry would necessarily run using a patients (small sample of) whole blood taken from a finger prick, and later defined as 1-2 microliters (a small drop on a finger tip), and perform the test and provide a result in one minute or less (later redefined as 15 seconds or less), with at least a 95% accuracy. Mr. Berman believed this device was capable of 97-98% accuracy. Three alternative designs were provided and given to the company on March 2. Two of the designs were diagrammed by Mathew Musho, PhD, the third design by a chemist and engineer from The Bio in Korea. The chosen of the three alternative product designs would bear the trade name GenViro! Swift.
The company then set to work, along with Matthew Musho, PhD (“Musho”), to evaluate the designs, keeping in mind the desired specifications of the DECN CEO and product Program Director, which included availability of components without wait time, time to market (assuming FDA EUA), whether the chosen method was applicable to use in point of care and at-home environments, time of assay from commencement of test and until result, size of the blood sample, and finally cost to produce. Given the company’s experience in working with biosensors and with electrode technology, the design review process took less time than originally expected. The entire process took 13 days. The last of these days used to determine which of the two Musho specifications was to be chosen. The design provided by The Bio was discarded because it could not be read on the existing company meter technology, and therefore would require additional development. At the end of this process, the company chose to produce the product shown in the illustrations, the second of the two Musho alternative versions, but shortly thereafter to begin work on the other Musho specification, to be used as a confirmation tool.
Product Design 1 (chosen)
The design above is in many regards similar to the direct antibody antigen approaches favored by some of the competitive companies in the Covid-19 testing field. But the major difference (magic) is that the approach used by the company in its GenViro! product allows for swift (15 seconds or less) results using a minimum of blood from a finger prick. As of this writing, work has commenced on the product specification above 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. The company is operating on an 8-week development schedule and is some 10 days into this schedule. The current development cycle is considered advanced development. For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company is preparing its final working concept filing, to be completed within days of this writing.
