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Replies to post #46467 on Decision Diagnostics Corp (DECN)
nonsequetor
07/24/17 4:08 PM
#46469 RE: zalicuslicious #46467
How does a product get tested and registered in the same month?
In March 2017 the company was approached by its Korean partner, The Bio Co., Ltd to design and fund a new product which the company will call GenPrecis!. This product, when completed, will represent a major improvement in diabetic glucose monitoring. The GenPrecis! system will be the first of its kind +/- 10% system. Current ISO (2013) and FDA (2014) guidelines call for glucose monitoring systems to meet a +/- 15% standard, whereby the meter and strip must be within +/- 15% in repeated samplings 95% of the time. GenUltimate! and GenChoice! are +/- 15% test strips, but in each case 97+% of the time in repeated samplings. GenPrecis! is designed to meet the written standards of the ISO and FDA at +/- 10%, 95% of the time – effectively setting a new standard. The company has been funding the development of this system product, and a test strip only derivative version. The system product will be ready for testing in September 2017 and will be registered for International sale in November 2017. However, the natural market for this product will be the U.S, and Canada where precision standards are higher for new products.