The following, which was copied from today's DECN Press Release, may address several of the questions and issues related to the EUA testing requirements! Given the demands, 2 weeks would seem to be optimistic!
Although the testing requested will be rigorous, it appears that testing will require 30 known Covid-19 positive samples and 30 known Covid-19 negative samples, all samples based on venous blood. The company is now looking to contract with a hospital or commercial laboratory to complete this testing.
Mr. Berman continued, "Upon receipt of these acknowledgments from the FDA, we contacted our partners in Korea, and provided specifications for all of the major components required for the GenViro!™ kit that are not used or a part of our GenUltimate! TBG product. Today our partners began ordering these components to begin build, assembly and bench testing for the post-prototype version of GenViro!™, Point of Care kit. These activities will become part of the completion of our Design Specifications file and Design History file for Genviro!™, and are necessary components of all FDA cleared medical devices."