Business
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
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.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"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 UnseenLOS 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. T...