COMPANY TO AGAIN SEEK FDA EUA FOR ITS CONFIRMATION KIT MAKING DECN THE FIRST TO OFFER TWO TYPES OF COVID-19 TEST KITS, A SCREENING KIT AND A POST SCREEN CONFIRMATION KIT
LOS ANGELES, CA / ACCESSWIRE / March 25, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) is an 18-year old, diabetes-focused bio-technology development firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! ("Sunshine") diabetes test strip, its GenAccord! Enhance ("Caterpillar") strip and meter systems for the uninsured and under-insured, its GenChoice! ("Ladybug") test strip now in the later stages of FDA 510(k) prosecution, and its GenUltimate! Precis products manufactured for International markets, and its GenViro! Rapid Kits for the real time testing for the Coronavirus (COVID-19) now seeking FDA Emergency Waiver (EUA).
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. This second kit will begin assembly for internal testing on April 1, with availability in late summer 2020. The method will again use a Biosensor (test strip-like device) and the company's Precise meter.
Keith Berman, CEO of DECN commented, "When we began exploring available testing methods for the Covid-19 virus, our goals were straight forward. Provide an easy to use, reliable, inexpensive test kit, designed for immediate use at the point of care, and eventually for at-home use. We accomplished these goals with our GinViro! Swift kit. And now we turn our attention to a second method for confirmation of those people who test positive during the Covid-19 screen. This second method will be true to our technology. GenViro! Confirm will be of our own creation and engineering and make use of our deep experience in Biosensors. This confirmation kit will have a wholesale price of $9.95. We will provide a kit unit forecast in coming days."
GenViro! Confirm will produce confirmatory results in less than a minute, also based on a small finger prick blood sample. The method is safe, effective, and its biggest benefit to the healthcare system is that the device will confirm or not confirm a positive result, saving the patient the trouble of going to a hospital or reference laboratory for confirmation testing. This is no small thing.
Mr. Berman concluded, "As this week goes on we will present a summary discussion of those specifics and issues we have considered in the past 21 days, a truly remarkable time for the company. We are truly thankful that the private sector, the Federal government and foreign governments are showing extreme interest in out GenViro! products. We have many more accounts to present."
ABOUT DECISION DIAGNOSTICS CORP
Decision Diagnostics Corp. is the leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters. DECN's products are designed to operate efficiently and less expensively on certain glucose meters already in use by almost 7.5 million diabetics worldwide. With new inspired technology diabetic test strips already in the final stages of development, DECN products compete on a worldwide scale with legacy manufacturers currently selling to 71+ percent of a $15+ billion at-home testing market. The company's new GenViro!TM product designed to test for the Coronavirus Covid-19, is not yet available in the United States or Puerto Rico but Emergency Waivers are in process, and the product concept has been presented to officials in Washington, DC by invitation and included follow up from Corona virus authorities both in the USA and from foreign governments.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of March 24, 2020, regarding the company's business and performance, its prospects, current factors, the economy, and other future conditions and forecasts of future events, circumstances, and results.
SOURCE: Decision Diagnostics Corp.