DECN Hails Completion of Its Genultimate! TBG Panacea System, 3rd Party Testing to Begin in Next 7 Days, Clinical Trials Testing to Begin in May
ACCESSWIRE•April 4, 2019
Equity Fund in Stealthy Move Tried to Gain Control of DECN In March, Just as a Big Box Was in Contact to Buy Genultimate TBG When Available, Sight Unseen
LOS ANGELES, CA / ACCESSWIRE / April 4, 2019 / Decision Diagnostics Corp. (OTC PINK: DECN) Decision Diagnostics Corp. is a 17 year old diabetes focused bio-technology R&D firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for a growing brand of glucose test strips and meters as highly accurate alternatives for legacy diabetic, proprietary, and pet testing glucose test strips.
Decision Diagnostics is pleased to announce and communicate that the company's GenUltimate! TBG test strip and meter, the next generation panacea at-home testing product for diabetics, has completed its advanced development and begun testing for verification in advance of third party testing and patient clinical trials as a part of the company's application for 510K clearance through the U.S. FDA.
Keith Berman, CEO of DECN commented, "The completion of GenUltimate! TBG is the seminal product development event in the company's history. This product is the answer to our plans and marks a watershed event in an industry awash with older technology and ‘me-too' products, typically designed in haste, for the singular purpose of gaining access to the huge and growing U.S. at home diabetic testing market. We view GenUltimate! TBG as a product where the market has reversed the value proposition and elected instead to gain access to our panacea product under the pretext of "those guys were able to do it and by-god it works.""
GenUltimate! TBG technology is designed to correct for Hematocrit (HCT) interference inherent in all at-home testing methodologies. By accomplishing this correction, GenUltimate! TBG offers precision and accuracy wished for, but virtually unheard of in at-home testing of diabetics. In fact, in several of our recent verification testing, GenUltimate! TBG out-performed even the reference methodology. This is quite the accomplishment.
Setting its own standard, GenUltimate! TBG will be capable of reporting glucose results at a reproducible rate of +/- 8.0%, in an industry where +/- 15% is not only the norm but also the published FDA guidance specifications. The company plans patent applications as soon as a current round of financing is accomplished. The GenUltimate! TBG technology will also be used as an enhancement to our GenUltimate! and GenUltimate! 4Pets test strips, now in worldwide commercial use.
Mr. Berman continued, "As stated previously we are putting all available resources and energy into our quickly growing product lines. We now recognize the value in use of our GenUltimate! TBG product and technology. To one company that has already contacted us, GenUltimate! TBG can be viewed as up to a $1.5 billion value add to a particular market leader. And while we have had discussions with a well branded big box, as GenUltimate! TBG grows closer to commercial availability, we expect contact with all of the major big box companies, that is if we choose not to license our panacea product to an august market leader."
The company's current portfolio of test strips includes its market established GenUltimate!, plus its GenChoice!, GenSure!, and GenUltimate! TBG test strips, its Avantage! and Precise! Glucometers, and its PetSure! and GenUltimate! 4Pets testing products for dogs, cats and horses. The company's GenChoice! test strips are part of a current 510K prosecution process with the U.S. FDA.
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 $12 billion at-home testing market.
Forward-Looking Statements
This release contains the company's forward-looking statements which are based
ACCESSWIRE•April 4, 2019
Equity Fund in Stealthy Move Tried to Gain Control of DECN In March, Just as a Big Box Was in Contact to Buy Genultimate TBG When Available, Sight Unseen
LOS ANGELES, CA / ACCESSWIRE / April 4, 2019 / Decision Diagnostics Corp. (OTC PINK: DECN) Decision Diagnostics Corp. is a 17 year old diabetes focused bio-technology R&D firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for a growing brand of glucose test strips and meters as highly accurate alternatives for legacy diabetic, proprietary, and pet testing glucose test strips.
Decision Diagnostics is pleased to announce and communicate that the company's GenUltimate! TBG test strip and meter, the next generation panacea at-home testing product for diabetics, has completed its advanced development and begun testing for verification in advance of third party testing and patient clinical trials as a part of the company's application for 510K clearance through the U.S. FDA.
Keith Berman, CEO of DECN commented, "The completion of GenUltimate! TBG is the seminal product development event in the company's history. This product is the answer to our plans and marks a watershed event in an industry awash with older technology and ‘me-too' products, typically designed in haste, for the singular purpose of gaining access to the huge and growing U.S. at home diabetic testing market. We view GenUltimate! TBG as a product where the market has reversed the value proposition and elected instead to gain access to our panacea product under the pretext of "those guys were able to do it and by-god it works.""
GenUltimate! TBG technology is designed to correct for Hematocrit (HCT) interference inherent in all at-home testing methodologies. By accomplishing this correction, GenUltimate! TBG offers precision and accuracy wished for, but virtually unheard of in at-home testing of diabetics. In fact, in several of our recent verification testing, GenUltimate! TBG out-performed even the reference methodology. This is quite the accomplishment.
Setting its own standard, GenUltimate! TBG will be capable of reporting glucose results at a reproducible rate of +/- 8.0%, in an industry where +/- 15% is not only the norm but also the published FDA guidance specifications. The company plans patent applications as soon as a current round of financing is accomplished. The GenUltimate! TBG technology will also be used as an enhancement to our GenUltimate! and GenUltimate! 4Pets test strips, now in worldwide commercial use.
Mr. Berman continued, "As stated previously we are putting all available resources and energy into our quickly growing product lines. We now recognize the value in use of our GenUltimate! TBG product and technology. To one company that has already contacted us, GenUltimate! TBG can be viewed as up to a $1.5 billion value add to a particular market leader. And while we have had discussions with a well branded big box, as GenUltimate! TBG grows closer to commercial availability, we expect contact with all of the major big box companies, that is if we choose not to license our panacea product to an august market leader."
The company's current portfolio of test strips includes its market established GenUltimate!, plus its GenChoice!, GenSure!, and GenUltimate! TBG test strips, its Avantage! and Precise! Glucometers, and its PetSure! and GenUltimate! 4Pets testing products for dogs, cats and horses. The company's GenChoice! test strips are part of a current 510K prosecution process with the U.S. FDA.
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 $12 billion at-home testing market.
Forward-Looking Statements
This release contains the company's forward-looking statements which are based
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