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Decision Diagnostics Announces the Completion of Development and the Onset of Clinical Trials for Its Fundamental Genchoice!(TM) Diabetic Test Strip
Decision Diagnostics Announces the Completion of Development and the Onset of Clinical Trials for Its Fundamental Genchoice!(TM) Diabetic Test Strip.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"LOS ANGELES, CA / ACCESSWIRE / October 10, 2017 / Decision Diagnostics Corp. (OTC PINK: DECN) is a manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate!™ diabetes test strip, the new internationally launched GenSure!™ \"Feather\" diabetes test strip, and the clinical trial ready GenChoice!™ \"Ladybug\" diabetes test strip.Today, the company is thrilled to announce that our new GenChoice!™ (the \"Ladybug\") diabetes test strip has completed its advanced development phase, has begun pre-clinical testing and will begin its clinical trials in Pennsylvania and California in November. The company expects to file its 510K application for U.S. FDA clearance in January 2018. In the meantime, the company will test market its new GenChoice!™ test strip in select International markets.Keith Berman, CEO of Decision Diagnostics, commented, \"We entered advanced development of the GenChoice!™ in November 2016. We have set an initial manufacturing forecast at 150,000 for 50 count boxes/units per month beginning in February 2018, and we intend to sell our GenChoice!™ in alternative packages of 25 count, 50 count, and 100 count boxes/units.\"DECN's first product, GenUltimate!™ glucose test strips, work with the market leading Johnson & Johnson's (\"J&J\") LifeScan OneTouch Ultra family of glucose testing meters and our GenSure!™ and GenChoice!™ test strips will also work each with a family of predicate testing meters. The company sells its GenUltimate!™ test strips in vials of 50, and 100 strips, its new GenSure!™ test strip in vials of 10, 25, and 50 strips, and it's now much anticipated GenChoice!™ test strips will be sold in vials of 25, 50, and 100 strips. The prices will remain evergreen in order to maintain worldwide accessibility per our socially responsible corporate undertaking.Mr. Berman continued, \"DECN anticipates utilizing select International markets as an early dry run for eventual U.S. sales and envisions the product generating over $100 million in annual revenues per our pro forma financials which we will post as soon as we complete the clinicals. GenChoice!™ will become DECN's largest tertiary revenue producer ...