Company Continues to Pursue Global Distribution Agreements During the 'Home Stretch' in U.S. Based FDA Level Testing
LOS ANGELES, CA / ACCESSWIRE / December 1, 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 an agreement for the sale of its Genviro! and Genviro! Pro Covid-19 testing products as well as several of its GenUltimate! blood glucose products through a large Moscow-based distribution company. The agreement provides for exclusivity in the Russian Federation territory and the Ukraine, countries that have a combined population of approximately 280 million people.
In a November 30th article in the Korea Times, https://www.koreatimes.co.kr/www/tech/2020/11...99908.html, it was reported that, 'Russia's virus test market is around $300 million.'
The GenUltimate! Precis products were brought to completion specifically for this Russian partner and present a special opportunity not often encountered. The company's GenUltimate! Precis product will replace a similar product formerly manufactured by J&J Lifescan as a later version of the popular worldwide OneTouch Ultra/Select product line. This product is no longer available for sale in the Russian Federation, the largest customer territory for the OneTouch Select Plus product line. Large markets devoid of competition do not often materialize.
The Russian Federation agreement comes on the heels of recently completed distribution agreements for GenViro! Covid-19 10.5 Second Saliva Swift Kits in Asia, including India, and more recently covering Puerto Rico, the Dominican Republic, the US Virgin Islands and areas across the Caribbean and Central America. The company had previously announced it had signed agreements with distributors/dealers covering Nigeria, Ivory Coast and Lebanon. The Russian Federation announcement and flurry of distributor/dealer activity comes as the company enters into the 'home stretch' in its GenViro! FDA testing submission efforts with a Pennsylvania-based FDA and CLIA certified testing lab.
NOT AVAILABLE IN THE UNITED STATES OR PUERTO RICO
'We had always recognized that Genviro! could find its footing internationally prior to the expected FDA authorization, and that's how things now appear to be playing out,' said CEO Keith Berman. 'We were also confident that with all of the activity and interest surrounding Genviro!, we would see an uptick in interest in our GenUltimate! blood glucose products, and certainly the Russian Federation agreement is emblematic of that. We look forward to receiving continued interest in both of our product lines globally, especially as we conclude our FDA testing for Genviro! and prepare for submission of our EUA application within the next few weeks.'
According to an August report by BBC Research and reported in the same Korea Times news article referenced earlier, the global Covid-19 diagnostics market will be valued at $35 billion this year and will grow an average of 14.8 percent annually to reach $112 billion by 2027.
Mr. Berman continued, 'The agreement with our Russian Federation partner will include our GenViro! Swift Kits for professional use as well as our GenViro! Kits for personal use. For us, this is a first. The actual number of kit orders will be controlled by the distributor. All of our GenUltimate! products are for personal use.'
Berman went on to say, 'The Korea Times article also reports that 'Test kit makers also say vaccines will not eat up the demand for testing because proper diagnosis is a precondition for proper treatment or prevention. In another article, https://www.koreabiomed.com/news/articleView.html?idxno=9593, it was reported that, 'Demand for Korean test kits is rising in Russia because of their high accuracy. Certainly these are big trends working in our favor and the future success of our GenViro!'
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 but hopefully should soon available in the European Union where a distribution partner has been identified and contracting is in the conclusive stages. The regulatory CE Marking is the responsibility of the distributor, a large PPE Sourcing Company.
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 US, 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. The company will also use data provided by its Korean R&D and contract manufacturing partner as part of their extensive product development schedule as well as the recently reported and better than anticipated XPRIZE testing outcomes that have been submitted well in advance of the extended XPRIZE December 8, 2020 deadline as yet a third validation of the testing methodology.
Beyond the testing, the company has received word from several of its large GenUltimate! blood glucose product distributors who are seeking to have Genviro! added to their Amazon product offerings upon FDA approval. Currently, Amazon only offers special licenses for point of care and professional use medical products, which would preclude the individual use GenViro! Kit from being available on Amazon, even after FDA approval is secured. 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 its best interest to offer limited exclusivity to one distributor once FDA authorization is achieved.
The company continues to recruit and accept applications from prospective domestic and international distributors. Inquiries can be directed to firstname.lastname@example.org.
This release contains the company's forward-looking statements which are based on management's current expectations and assumptions as of November 30, 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.
ADDITIONAL CONTACT INFORMATION:
Decision Diagnostics Corp.
Shep Doniger 561-637-5750|
SOURCE: Decision Diagnostics Corp.
View source version on accesswire.com: