IdentifySensors Biologics has joined forces with East West Manufacturing for the production of medical diagnostic devices.
These diagnostic devices will be used for the detection and differentiation of various infections from a single saliva sample.
Leveraging printed solid-state electronic biosensors, the testing platform will quickly identify pathogen DNA and RNA in samples of saliva.
IdentifySensors Biologics COO Ghazi Kashmolah said: “We are excited to partner with East West Manufacturing to assist us with the commercialisation of our diagnostics devices upon FDA approval for deployment in US markets.
“East West brings knowledge and experience in manufacturing electromechanical products and printing technology under ISO 13485 quality management system.”
East West will manufacture the single-use, disposable test cartridges and reusable Bluetooth reader components of the platform.
The reader links to cloud technology through a mobile app for reporting results.
East West has started pilot production of devices intended for use in clinical trials.
IdentifySensors aims to functionalise several biosensors for identifying various diseases, including respiratory illnesses such as respiratory syncytial virus, influenza and coronavirus.
It is also focused on developing biosensors for diarrheal pathogens such as adenovirus, norovirus, rotavirus and multiple sexually transmitted diseases.
IdentifySensors CEO and cofounder Gregory Hummer said: “We are pleased we began manufacturing in preparation for our clinical studies in time for this year’s cold-and-flu season.
“We have seen very encouraging preliminary data from our own laboratory and are excited to put this to use in clinical environments.”