DECN - FDA Conversations - from PRs
3/11 - The company has retained FDA counsel who is in the process of securing expected emergency waiver for diagnostics and diagnostic devices.
3/16 - We are awaiting release of blood samples from previously infected people in Daegu, Korea, so that we can complete testing and make a final report to the U.S. FDA so that we may secure our Emergency Waiver. In the meantime, all other requests made by the FDA will be met this week and next. Further, we will engage in the EU with administrators of the ISO standard CE regulatory process this week.
3/23 - Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip that will go into production just as soon as the FDA grants emergency status to the DECN product.
3/25 - Today, DECN announces that the company, through its advanced development team in Korea, has arrived at a second Covid-19 test methodology, a modified Serology method, that at the completion of documentation, be put through the FDA Emergency Waiver (EUA) process.
4/6
• The application was filed on Friday 4/3/2020 late in the afternoon, acknowledged less than three hours later, and assigned for EUA review on Saturday 4/4/2020. There have already been several contacts between the FDA EUA review group and the company's FDA counsel.
• Mr. Berman continued, "Our Korean partners, my primary consultant, who came out of retirement to create the design drawings and commentary, our FDA lawyers, and our own employees and those of our Korean partner jumped all over our efforts in what became a fundamental initiative. The application we filed with the FDA last Friday is our first fulfillment of these efforts, after weeks of internal and external discussion, planning, designing and redesigning and finally completion of the method design. If April 3 is the date where we drove our product stake into the ground, then the new product was conceived, designed and readied for FDA EUA review in approximately 45 days. Our method is unique, minimally invasive, doesn't require a painful nose swab, and true to its trade name -- Swift."
4/7
• DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020. Later on this same day FDA counsel had several exchanges with FDA EUA staff. In one of those exchanges, the FDA provided Guidance for our final product testing.
• As early as Saturday April 4, it was clear that the FDA review staff was aware that our methodology was different than those slower and older methods that had received FDA EUAs, or were in review. 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. "
4/23
• Subsequent to this grant, we have had two long conversations with FDA staff and management, the first of these discourses between our FDA counsel and FDA staff, the second conversation, on April 14, 2020, between our FDA counsel, DECN management and DECN technical and product development professionals. The purpose of these calls was to clarify and differentiate our GenViro! Swift kit, Pro Version, from the myriad of antibody/antigen methodologies that our product has been inaccurately compared to, primarily in public, but not scientific forums.
• Discussions with FDA staff and management have focused on the differences inherent to our Genviro! Swift product, those differences that add to GenViro!'s value in use. For example the FDA is concerned with reagent and sample contaminants that may be present during testing, primarily because the samples taken from a patient using current methods must travel from the site of the patient to a laboratory for assay. This travel at times takes hours, sometimes days. GenViro! Swift does not make use of any reagent to provide a result. Therefore there will be no sample contaminant. Also, the patient sample it makes use of, a small drop of blood, does not have to travel. In fact the assay and answer are provided on the spot, in 15 seconds, right in front of the patient. We believe we have completed discussions and have come to an understanding with the FDA on all of the testing required to receive the EUA. We plan to engage a specialty reference laboratory to complete this testing in the next 10 days. Testing should take about a week.
