Company Being Sought Out Worldwide for Global Distribution Agreements Based Testing at FDA; CLIA Certified Lab
Company Being Sought Out Worldwide for Global Distribution Agreements as It Enters the “Home Stretch” in U.S.- Based Testing at FDA & CLIA Certified Lab
LOS ANGELES, CA / ACCESSWIRE / November 6, 2020 / Decision Diagnostics Corp. (OTC PINK:DECN) www.decisiondiagnostics.co, a leading manufacturer and worldwide distributor of diabetic test strips engineered to operate on legacy glucose meters through its subsidiary Pharma Tech Solutions, Inc., today announced it has signed a number of distribution agreements for its GenViro! Covid-19 10.5 Second Saliva Swift Kits covering Puerto Rico, the Dominican Republic, the US Virgin Islands and areas across the Caribbean and Central America. GenViro! Swift cannot yet be sold in Puerto Rico. This most recent announcement comes less than a week after the company announced it had signed agreements with distributors/dealers covering Nigeria, Ivory Coast and Lebanon. This heightened number of additional distributor/dealer agreements comes while the company enters what it has referred to as the “home stretch” in its FDA testing submission efforts utilizing the assistance of a Pennsylvania-based FDA and CLIA certified testing lab.
“We are pleased with the further demonstration of interest on a global scale in Genviro! and will continue to rapidly assess each inquiry. As I have said previously, we are also in discussions with several of our large GenUltimate distributors who have expressed interest in having, after FDA authorization, Genviro! added to their Amazon professional use product offerings,” said CEO Keith Berman.
GenViro! Swift kits are not yet available for sale in the USA or Puerto Rico. Emergency FDA Authorization is in process
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 newly inspired technology, and 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!™ products designed to test for Covid-19 are not yet available in the United States or Puerto Rico, but Emergency (EUA) Waivers are in process with the U.S. FDA with additional submissions to take place in the near future. The company has also signed an agreement with an FDA and CLIA certified Pennsylvania-based testing partner to complete testing per current FDA guidelines and continues to look forward to the FDA authorization of its EUAs.
The same data that will be produced by the company’s Pennsylvania testing partner will be used for submissions to the EU and Russian Federation. We will also use data provided by our Korean
R&D and contract manufacturing partner as part of their extensive product development schedule and as part of the XPRIZE initiative.
Currently, Amazon offers special license for point of care and professional use medical products, which would preclude the individual use GenViro! Kit from being available on Amazon in the near term. In addition, the U.S. FDA has not provided guidance needed for the authorization of antigen method home use Covid-19 diagnostic products.
Two of the company’s GenUltimate product distributors have these “professional use” arrangements with Amazon, with a third distributor application in the works, although the company may determine that it is in our best interest to offer limited exclusivity to a single distributor once FDA Authorization is achieved. The company continues to recruit and accept applications from prospective domestic and international distributors. Inquiries may be directed to: info@decisiondiagnostics.co
Forward-Looking Statements:
This release contains the company’s forward-looking statements which are based on management’s current expectations and assumptions as of November 5, 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.
CONTACT INFORMATION:
Decision Diagnostics Corp.
info@decisiondiagnostics.co
www.genultimate.com
www.genultimatetbg.com
www.pharmatechdirect.com
FURTHER CONTACT INFORMATION:
Decision Diagnostics Corp.
Shep Doniger 561-637-5750
SOURCE: Decision Diagnostics Corp.
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https://www.accesswire.com/615003/DECN-Continues-to-Add-GenViro-Dealers-With-an-Agreement-Covering-Puerto-Rico-the-Dominican-Republic-the-US-Virgin-Islands-and-Geographies-Across-the-Caribbean-and-Central-America
