SOTECH Health has filed for Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a portable, reusable, rapid, at-home breath test device for Covid-19.
The company licensed the platform technology associated with the device, which is designed to deliver results within 30 seconds, from the University of Texas (UT) at Dallas.
SOTECH further optimised the breath test technology over the past 18 months under an intellectual property assignment/sponsored research agreement (IPA/SRA) with the university.
UT Dallas systems biology science professor Dr Shalini Prasad said: “This electrochemical gas-sensing technology looks for volatile organic compounds in highly complex and dense environments, delivering high precision at ultra-low concentrations.
“To get extreme sensitivity and extreme selectivity for your target, our unique design had to have a sensing element that wasn’t impacted by the many interfering gases, or by factors like humidity and temperature changes.”
The sensor technology in the breath test device identifies the target chemical species and leads to an electrochemical reaction, which the device breaks down to generate electrons that in turn create a current at a particular voltage.
After the sensor identifies gaseous metabolites that indicate Covid-19, results are sent to the Cloud and companion smartphone app of SOTECH Health.
People who test positive are directed to receive a standard test to confirm Covid-19.
SOTECH Health founder and CEO Craig Micklich said: “A Cloud-based AI records anonymised analytics for health care professionals and public agencies to track results in a way that will help focus outbreak management efforts where they are most needed.”
The company secured a grant from the Center for Advancing Point of Care Technologies under the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative to support the development of this breath testing technology for Covid-19.
Earlier this month, researchers at the University of Washington School of Medicine in Seattle, US, reported that in a study the Tasso device to draw blood samples in at-home settings was found to be useful for measuring antibodies against SARS-CoV-2.