Dallas-based Sotech Health has submitted the device to the FDA for an emergency use authorization. It’s also seeking regulatory nods in Canada, the United Kingdom and the European Union.
Phillips-Medisize (Hudson, Wisconsin) is readying its global production facilities to keep pace with the anticipated demand for the Sotech Health breath analyzer. A Molex company, Phillips-Medisize has 36 facilities worldwide.
The contract manufacturer boasts that its electronics, product and manufacturing engineers worked alongside the startup’s engineers to ensure intuitive, convenient product operation. They improved on each new product prototype until they reached what they considered to be an easy-to-use, validated product design ready for swift production ramp.
Here’s how it works: A person blows into the handheld device’s disposable mouthpiece for 6 seconds, with a highly sensitive, electrochemical sensor detecting traces of chemicals related to the SARS-CoV-2 virus within 30 seconds. Sotech Health said it has completed 31,000 breath tests using the product.
Shalini Prasad, a professor of bioengineering at UT Dallas, created the electrochemical sensor technology. Results — along with location, temperature and humidity data — get uploaded to a cloud-based AI, which Sotech Health officials think could help predict the likelihood of future COVID infections in particular geographic locations.
“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,” Sotech Health founder and CEO Craig Micklich said in a news release.
“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.”