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Monday, October 25, 2021

Comeback Time for Decision Diagnostics Corp (OTCMKTS: DECN)

Decision Diagnostics Corp (OTCMKTS: DECN) has been on the move northbound in recent trading since reversing off $0.102 lows. The stock spiked to highs over $0.45 in August and speculators in the Company are hoping for a return to previous levels. DECN saw a big move as it introduced its GenViro(TM) Corona Virus Screening Kit; a timely, simple to use, cost effective instant test kit that provides results in as little as 10.5 seconds, based on a small finger prick blood sample.

On November 16 DECN issued a quarterly report showing unaudited numbers of $615,000 in the treasury, $180,000 in Inventory and $1.2 million in accounts receivable as of September 30, 2020. DECN reported revenues of $1,457,354 for the 9 months ended September 30, 2020 compared to $1,646,369 for the same period last year. DECN also released a detailed and current overview of its business and the GenViro(TM) Corona Virus Screening Kit.

Decision Diagnostics Corp (OTCMKTS: DECN) 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.

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 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 and as part of the XPRIZE initiative which is progressing as yet a third validation of the testing methodology.

GenViro(TM) Corona Virus Screening Kit has been featured by main stream media with CBS New York coverfing it in a segment called: Max Minute: Diabetes Company’s Affordable, Fast Coronavirus Test May Be Key To Reopening Businesses

Beyond the testing, the company has received word from several of its large GenUltimate 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.

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DECN

Last week DECN reported it has signed a number of distribution agreements for its GenViro! 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.

On November 12 DECN reported its donor study has entered its final stages, and that having yielded better and quicker than anticipated results a separate feasibility study will not be required. The company is now actively testing known positive and negative Covid-19 patients in an effort to finish its FDA EUA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed. We are reviewing drafts of this application currently. The donor study will provide exact data requirements for FDA EUA, EU CE Mark and Russian Federation applications for the GenViro! Saliva Swift Kit for the detection of Covid-19.

DECN CEO Keith Berman stated: “Testing for GenViro! has been so encouraging that on Tuesday, November 10, 2020 our certified testing lab partner informed us that we can avoid doing two studies and instead move to direct patient testing of positive and negative Covid-19 human samples required for FDA submission. That’s taking place right now. As such, we have been informed that testing is in the “home stretch,” and we estimate an FDA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed. The testing of positive and negative human saliva samples is demonstrating a number of critical findings.”

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DECN is an exciting story in small caps that still shows the scars of its suspension earlier this year with the skull & crossbones designaiton from OTCMarkets Group. DECN saw a big move as it introduced its GenViro(TM) Corona Virus Screening Kit; a timely, simple to use, cost effective instant test kit that provides results in as little as 10.5 seconds, based on a small finger prick blood sample. DECN has been trending northbound in recent days since reversing off $0.102 lows and speculators are looking for a return to preivous highs. Things are looking up at DECN, CEO Keith Berman stated earlier this week: “Testing for GenViro! has been so encouraging that on Tuesday, November 10, 2020 our certified testing lab partner informed us that we can avoid doing two studies and instead move to direct patient testing of positive and negative Covid-19 human samples required for FDA submission. That’s taking place right now. As such, we have been informed that testing is in the “home stretch,” and we estimate an FDA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed. The testing of positive and negative human saliva samples is demonstrating a number of critical findings.” Microcapdaily has been reporting on DECN since the stock was .05. We will be updating on DECN when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with DECN.

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Disclosure: we hold no position in DECN either long or short and we have not been compensated for this article.

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