Emergency Waiver in Progress With U.S. FDA for Use in Entities That Employ Staff Professionals, Wholesale Price to Be $6.95, Walk-In Patient Cost Expected to Be $29.95
LOS ANGELES, CA / ACCESSWIRE / March 16, 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! 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.
Today, DECN announces in this first of four releases expected in the next 14 days, further details of our revolutionary Coronavirus (Covid19) screening test GenViro!™. Our product, introduced to the world only 14 days ago has entered its crucial development stage. 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. Only two diagnostic methodologies have been approved in the EU, none with the cost effectiveness or promise of GenViro! Our plan is designed to bring at least 100,000 of our kits to market in the USA and Canada, and another 100,000 in Europe, during the month of May 2020.
Although the overall goal of our marketing plan for GenViro!™ is to sell the product directly to consumers for self-testing. Our initial efforts will be to provide overall verification of the GenViro!TM efficacy by working directly through organizations that regularly employ licensed medical technologists, or nurses (chain pharmacies, nursing home chains, and walk-in clinics). Our GenViro!™ will allow for the administration of the Covid-19 test through a “finger-stick,” producing results in less than one-minute.
Keith Berman, CEO of DECN commented, “We plan a total of three additional releases in the coming days, the first new release discussing the product itself and why it is so special, the second release will discuss a roll-out plan, and the third release will summarize everything we have discussed to date, and talk about a second product we are working on, making use of the same technology, that is uber precise and destined to find its way into hospitals.
Our second GenViro™ product will be a confirmatory method for the GenViro™ screening methodology we have talked about in great detail, but also this second methodology will be capable of confirming other methodologies that may be in use.”
Mr. Berman concluded, “I will say again, that we have developed a Coronavirus screening method, not a cure or a vaccine for this virus. The cost of our test kits will be sold at the wholesale level at $6.95. We expect our partners, chain pharmacies, nursing homes, clinics etc. to charge $24.95 to $29.95. We strongly believe there will be no shortage of people lining up to be tested. Once we complete the Emergency Waiver portion of our launch and move into ramping up of commercial production, we plan to offer testing kits and meters to patients for testing at-home. We expect the vast majority of the 420 million test kits we plan to manufacture in the first year of production will be sold to individuals for self-testing.”
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!™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.
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of March 15, 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.
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