IdentifySensors Biologics, a leading developer of digital diagnostic technologies, has partnered with Atlanta-based East West Manufacturing to produce medical diagnostic devices intended to rapidly detect and differentiate multiple infections from a single saliva sample.
The testing platform uses printed solid-state electronic biosensors intended to rapidly detect pathogen DNA and RNA in saliva samples.
"We are excited to partner with East West Manufacturing to assist us with the commercialization of our diagnostics devices upon FDA approval for deployment in US markets," said Ghazi Kashmolah, COO of IdentifySensors Biologics. "East West brings knowledge and experience in manufacturing electromechanical products and printing technology under ISO 13485 quality management system."
East West will produce two components of the platform: single-use, disposable test cartridges and a reusable Bluetooth reader, which connects to cloud technology through a mobile app to report results. East West has begun pilot manufacturing of devices to be used for clinical trials this fall.
IdentifySensors intends to functionalise multiple biosensors to detect a wide range of diseases, including respiratory illnesses, such as COVID-19, influenza and RSV. Diarrheal pathogens, including Norovirus, Rotavirus and Adenovirus are under development along with multiple sexually transmitted diseases.
"We are pleased we began manufacturing in preparation of our clinical studies in time for this year's cold-and-flu season," said Gregory Hummer, MD, CEO and cofounder of IdentifySensors. "We have seen very encouraging preliminary data from our own laboratory and are excited to put this to use in clinical environments."
This platform is fully patented. The testing device and its multiple elements are not yet approved for sale in the United States or other international markets.
IdentifySensors Biologics is digital-diagnostic technology company focused on developing advanced pathogen-detection capabilities. The company's technology has expanded into multiple industries and applications, such as diagnostics, food safety & sustainability, environmental monitoring and national security. For more information visit www.identifysensors.com