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Tuesday, November 29, 2022

The Exciting Rise of GenViro; Decision Diagnostics Corp (OTCMKTS: DECN)

Decision Diagnostics Corp (OTCMKTS: DECN) is making a powerful move up the charts as the Companies GenViro(TM) Corona Virus Screening Kit continues to gain traction as the Company prepares for U.S. based testing. The GenViro(TM) Corona Virus Screening Kit is 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. The device costs $15 and the test strip kit costs $30. Microcapdaily has been reporting on DECN since the stock was .05.

As coronavirus spreads around the world, safely reopening the country and the world depends almost entirely on testing – widespread, affordable, accurate and accessible testing. Antibody tests and nasal swabs currently on the market are both invasive and take up to weeks for results. DECN many have the solution with its GenViro(TM) Corona Virus Screening Kit. According to CEO Keith Berman its a “game changer. We’re the product of choice because it works, it works fast and because it’s affordable.  That’s why companies are interested. Businesses can test their workers as often as they want, in a matter of seconds, every day if they like,” said Berman.

Decision Diagnostics Corp (OTCMKTS: DECN) is a nationwide prescription and non-prescription diagnostics and home testing products distributor. The Company markets its GenUltimate, GenSure, PetSure (test strips for dogs and cats) and GenChoice (in FDA 510(k) review), its panacea GenUltimate TBG glucose test strips and meter (in 3rd party testing), its GenPrecis test strips and meter (for private label sale), and its GenUltimate 4Pets glucose test strips and meter for the diabetic testing of dogs, cats and horses. Decision Diagnostics is FDA approved and hase complete R&D and manufacturing facilities in South Korea.

DECN'S GenViro!(TM) Corona Virus "Swift" Kit, Now to Be ...Decision Diagnostics introduced its GenViro(TM) Corona Virus Screening Kit in March. The Company stated at the time: Today, in the third discussion of our break-through test for the coronavirus (COVID19), we present the Coronavirus test kit and the Phase 1 unit forecast. The introduction of our new screening methodology for the Coronavirus (Covid19) will provide a timely, simple to use and cost effective solution for the screening of the frightening COVID19 virus. First uses of our kits will be in pharmacies, doctor’s offices, clinics and urgent care centers, and long term care facilities. We anticipate the sale of 420,000,000 kits in the first full year of commercial sale. The company has retained FDA counsel who is in the process of securing expected emergency waiver for diagnostics and diagnostic devices.

GenViro(TM) Corona Virus Screening Kit has been getting noticed 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. According to the segment: NEW YORK (CBSNewYork) – “We’re the product of choice because it works, it works fast and because it’s affordable,” According to DECN CEO Keith Berman says of the GenViro(TM) Corona Virus Screening Kit “It works by taking a finger-prick drop of blood and, through sophisticated micro-processing, arrives at a result within 30 to 45 seconds. The device costs $15 and the test strip kit costs $30. That’s why companies are interested. Businesses can test their workers as often as they want, in a matter of seconds, everyday if they like,” said Berman. The segment ends with “It’s not free, but it is an affordable enough technology that could open up restaurants, movies, all manner of businesses and group venues. The company hopes to have all the FDA-mandated testing done by next week. If approved, Berman says they could ship as many as 100,000 units immediately and be making up to 400,000 a week within 60 days.”

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DECN

On August 3 DECN announced its support for the recently issued FDA Covid-19 At-Home Use Template saying it, “Contains much of what was in our May 1st At-Home Application to the FDA.” The company says it is 100 percent behind the issuance of at-home testing guidelines, and that it is now preparing to amend its first EUA submission PEUA200947, for its GenViro! Blood Swift Kit for at-home use. Shortly thereafter we anticipate filing a separate EUA application with the FDA for its GenViro! Saliva Swift Kit for home use. Both applications for the home use of GenViro! Swift are expected to meet the new FDA template, the FDA’s first such template issued by the FDA. No Covid-19 home-based test kits have as yet been authorized by the FDA, although several at-home specimen collection kits have been authorized. Nonetheless, experts universally agree that routine at-home testing of people who may be asymptomatic can be transformative in the effort to significantly slow the spread. Current at-home specimen collection kits do not provide at-home point of care testing.

DECN is currently preparing for U.S. based testing of its COVID-19 test kits. The company just received completed testing from its Korean partner where the required 75 non-infected donors were tested for both blood and saliva (a total of 150). The next step for our partner will be to test known infected samples. These tests will be done in conjunction with a Korean teaching hospital or similar institution. Once completed, this testing data will provide the filing data needed for the anticipated EU CE Mark and registration of our GenViro! Swift kits in other off-shore countries as may be required. In addition, the company has ordered approximately 600 Genviro! Swift testing strips delivered to us in vials for the feasibility rounds of testing in the USA. The company has received the first 300 of these sensors and plans to begin testing for saliva based samples with its chosen U.S. based partner. After this initial USA testing, another 600 test strips for the second, more demanding study.

DECN expects to receive the U.S. supply of production testing samples during the first week of August 2020 which is expected to coincide with the company’s selection of an experienced US based clinical testing partner. The company has narrowed potential US testing partners to two clinical trials organizations and allied laboratories and expects to announce its decision in the next few days. That organization will lead the clinical trials in the U.S. that DECN expects will be the final requirement to secure FDA emergency authorization.

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Currently running higher DECN is an exciting story in small caps establishing itself as a volume leader and proven runner. DECN GenViro(TM) Corona Virus Screening Kit provides results in as little as 10.5 seconds, 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 can be used to screen out the 97% or 98% of those tested that are negative for COVID-19.  DECN is currently preparing for U.S. based testing of its COVID-19 test kits. The company just received completed testing from its Korean partner where the required 75 non-infected donors were tested for both blood and saliva (a total of 150). The next step for our partner will be to test known infected samples. These tests will be done in conjunction with a Korean teaching hospital or similar institution. Once completed, this testing data will provide the filing data needed for the anticipated EU CE Mark and registration of our GenViro! Swift kits in other off-shore countries as may be required. In addition, the company has ordered approximately 600 Genviro! Swift testing strips delivered to us in vials for the feasibility rounds of testing in the USA. 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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