Business
DECN Receives Completed Clinical Trial Data, Charts and Spreadsheets Essential for its Imminent Genchoice! Test Strip
DECN Receives Completed Clinical Trial Data, Charts and Spreadsheets Essential for its Imminent Genchoice! Test Strip.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"Company to Begin Sales in Select International Markets While the U.S. FDA Reviews its 510k Application LOS ANGELES, CA / ACCESSWIRE / November 6, 2018 / Decision Diagnostics Corp. (OTC PINK: DECN) is a 16-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 the GenUltimate! ("Sunshine") diabetes test strip, the internationally launched GenSure! ("Feather") diabetes test strip, and the clinical trial in process concluded GenChoice! ("Ladybug"), the new PetSure! test strip for the diabetic testing of dogs and cats, and the panacea GenPrecis! ("Dragonfly") diabetes testing system, ready for clinical trials.DECN reports that the CEO Keith Berman has received the concluded patient clinical trial study, managed through its partner The Bio Co., Ltd in South Korea. The study was commissioned in May 1, 2018 and was completed on October 31, 2018. During the study, medical workers at the hospital that hosted the study went on strike for approximately 45 days, causing a delay. The clinical study itself was supervised at the hospital by a credentialed professional working under the standards of the International Review Board.Keith M. Berman, CEO of DECN commented, "The company is delighted that the patient clinical study for our impressive GenChoice! glucose test strip is now complete. This was the last step in a product development that began in earnest in December 2017. We have retained a U.S. based IRB to organize the data in a manner consistent with the expectations of the U.S. FDA and those countries using the alternative ISO standard. The data received is outstanding and exceeds all newly established standards for accuracy and precision. But most exciting is that GenChoice! will compete in a world-wide market."Mr. Berman continued, "DECN intends to complete the configuring of the clinical report in the next 30 days, and during that time to implement its marketing plan for GenChoice! in select International markets where little or no immediate International registration is required. The clinical study will be provided to the expert firm who we previously tasked with completing our 510K application. We still anticipat...