Breath-sensor system developed for rapid COVID-19 detection

SOTECH Health’s reusable breath-test device leverages sensor research from The University of Texas at Dallas with a cloud-based artificial intelligence (AI) platform and Phillips-Medisize’s human-centered product design, rapid prototyping, and end-to-end manufacturing expertise.

Paul Chaffin, president, medical and pharmaceutical Solutions, Molex, said: “We believe in SOTECH Health’s transformative mission to enable fast and accurate health checks, which are crucial to regaining normalcy in everyday lives. Our long history of working with companies at every stage of their product lifecycle has proven critical in helping SOTECH Health optimize and finalize functional product prototypes while preparing for a rapid manufacturing ramp upon regulatory approval.”

To screen for COVID-19, a person blows into the handheld device’s disposable mouthpiece for six seconds. A sensitive, electrochemical sensor looks 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 on-site or from a distance through WiFi/Bluetooth connectivity, alleviating the need for healthcare professionals to conduct the tests.

To date, SOTECH Health has completed 31,000 breath tests. Craig Micklich, founder and CEO of SOTECH Health, said: “Our innovative breath analyzer will change the game in COVID-19 detection by quickly and accurately screening people in densely populated settings, such as airports, businesses, cruise lines, schools, and stadiums.

Through our collaboration with Phillips-Midsize, 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.” Seamless teamwork between SOTECH Health and Phillips-Medisize has facilitated a fast-track product design and development process. Phillips-Medisize’s team of electronics, product, and manufacturing engineers worked alongside SOTECH Health’s engineers to ensure intuitive, convenient product operation.

Each new product prototype has been executed with a focus on continuous improvement and quality, resulting in a validated product design ready for a swift production ramp. At the heart of each device is electrochemical sensor technology 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. A suite of machine learning and predictive analytics tools based on sensor and AI IP owned by SOTECH Health assess results, determine the probability of future infection, and provide geographic “heat maps” created from aggregated data within a geographic region.

Phillips-Medisize is readying its global production facilities to keep pace with the anticipated demand for SOTECH Health’s breath analyzer. SOTECH Health has submitted the device to the U.S. Food and Drug Administration for emergency use authorization and is awaiting regulatory approvals from Health Canada, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), and the European Union’s In Vitro Diagnostic (IVDD) self-declare and then IVDR once regulations are applicable.

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