Phillips-Medisize, a developer of drug delivery, diagnostic and medtech devices, has announced a collaboration with healthcare startup SOTECH Health, to accelerate the development of a breath-sensor system that detects COVID-19. The start-up’s reusable breath-test device leverages sensor research from The University of Texas at Dallas, with a cloud-based artificial intelligence (AI) platform. Phillips-Medisize will contribute its human-centered product design, rapid prototyping and manufacturing expertise.
To screen for COVID-19, a person blows into the handheld device’s disposable mouthpiece for six seconds. An electrochemical sensor detects for traces of certain chemicals in the sample, which indicate exposure to SARS-CoV-2, the virus strain that causes COVID-19. Results are available in less than 30 seconds. Tests can be self-administered and monitored onsite or from a distance through WiFi/Bluetooth connectivity, alleviating the need for healthcare professionals to conduct the tests, the company claims.
“We believe in SOTECH Health’s transformative mission to enable fast and accurate health checks, which are crucial to regaining normalcy in everyday lives,” said Paul Chaffin, President, Medical and Pharmaceutical Solutions, Molex. “Our long history of working with companies at every stage of their product lifecycle has proven critical in helping SOTECH Health optimise and finalise functional product prototypes while preparing for a rapid manufacturing ramp upon regulatory approval.”
Craig Micklich, founder and CEO of SOTECH Health said: “Through our collaboration with Phillips-Medisize, we have engineered a solution capable of screening for COVID-19 infection status as fast as it takes someone to walk through a metal detector at an airport or sports stadium. Phillips-Medisize is perfectly positioned to support SOTECH Health’s global go-to-market strategies while empowering our efforts to screen for other critical respiratory diseases and conditions in the future, including the flu and pneumonia.”
The device’s electrochemical sensor technology was developed by Dr Shalini Prasad, a Professor Of Bioengineering at UT Dallas. Additional location, temperature, humidity and communication sensors gather relevant data, along with test results, which are sent to a cloud-based artificial intelligence (AI) model.
SOTECH Health has submitted the device to the FDA for emergency use authorisation and is awaiting regulatory approvals from Health Canada, the United Kingdom’s MHRA and the European Union’s In Vitro Diagnostic (IVDD) self-declare and then IVDR once regulations are applicable.