The purpose of the VisuGen Global E. coli test under development is to provide a rapid on-site water monitoring method to test environmental water or to assist produce growers establish a Microbial Water Quality Profile in compliance with the FSMA produce rule requirements. Our method will provide rapid on site testing and results to avoid costly recalls and reduce illness due to microbial contamination of produce. The produce rule of FSMA mandates that produce growers test their irrigation and process water with FDA compliance phased in over the next four years. The most significant technical hurdle for accomplishing high sensitivity tests is finding low copy numbers per unit volume of the sample; for example 126 copies of the bacterium E. coli in a glass of water (100 milliliters) that is the threshold for safe irrigation recreational water use. VisuGen has discovered a strategy to capture and concentrate genes onto a unique binding material. Furthermore, the captured genes can be visualized by an affordable and rapid method that can be performed simply on sites such as at a recreational lakes or beaches, or by produce growers using a cell phone to read and record the result.
