SOTECH Health recently applied to the U.S. Food and Drug Administration for emergency use authorization for the device. The company is waiting for the agency to follow up with any questions. SOTECH Health also expects to have regulatory approval in Europe in November.
The device isn’t a diagnostic test for COVID, company officials said. Unlike a PCR test, SOTECH Health’s device doesn’t detect specific elements of the virus. Instead, the device detects markers of the body’s response to the virus.
Shalini Prasad , a professor of bioengineering at UT Dallas and a research collaborator for SOTECH Health , said the testing device quickly screens people for illness, so that they then know to follow-up with a diagnostic test. The sensor on the testing device detects a combination of chemicals called “volatile organic compounds” that are present in a person’s breath.
“It will have the sensitivity of a screening test, so it will help you quickly identify asymptomatic sick people,” Prasad said.
Kade France, SOTECH Health’s chief technology officer, said that in addition to the breath sensor, the device uses software to analyze data and connect each device to the cloud, to provide more insight into the transmission of the virus
Craig Micklich, SOTECH Health’s CEO, said that in clinical studies, the company has conducted over 29,000 breath tests.
Results showed the test has a high level of sensitivity of 98.9%, with a 97.3% negative predictive value, he said. Negative predictive value is the ratio of subjects truly diagnosed as negative to all those who had negative test results.
A test with this level of sensitivity could prove useful, independent experts said.
Dr. Sophia Koo, an infectious disease physician at Brigham and Women’s Hospital in Boston, said that it’s important for such a test to have a high negative predictive value. That means the test’s results indicate with high confidence that the individual likely doesn’t have COVID and wouldn’t need further evaluation. Koo wasn’t involved in this research.
“The only caveat to this work is that it really has to be validated well to make sure that it’s reproducible,” Koo said.
Researchers said it’s significant that SOTECH Health’s device measures a combination of chemicals.
Cristina Davis, a professor of mechanical and aerospace engineering at University of California Davis, said that “usually a constellation of chemicals” are more indicative of whether an individual has a specific disease, not a single chemical. Davis, the associate dean for research at UC Davis, was not involved in this research.
Davis, who is also the incoming chair of the International Association of Breath Research, said that there’s a lot of activity in the field right now.
“This [type of research] has been in the works for a few decades,” she said. “But right now, the COVID pandemic provided an opportunity for people to really hone in and develop things that could help with this particular health problem.”
She said, “We understand the medical physiology of breath, and we’re starting to develop engineering and instrumentation that can exploit those chemical signatures for specific purposes.”
According to Davis, the low levels of these chemicals in the breath make it difficult to develop technology sensitive enough to make these kinds of measurements.
“These chemicals are at extremely trace concentration levels,” she said. “It makes it challenging from an engineering and sensor perspective to amplify that signal and then to be able to measure it with fidelity.”
The variety of detection strategies being developed around the world helps address this problem. The “different approaches have different values for different types of applications,” she said.
These breath tests do not require the same molecular consumables, or single-use laboratory reagents and supplies, that are needed for PCR and rapid antigen testing tests, she said. Different supply chain issues could come up, she said, but it’s good to have multiple types of testing options available.
SOTECH Health and its UT Dallas research partners are waiting for FDA authorization, and then they’re confident that they can scale up production of the device, Micklich said. They’re planning to sell the device to businesses first.
“This area of research has much potential to offer in terms of both screening and diagnostics,” Davis said. “I think that there’s room for multiple technologies that are based on exhaled breath to play a role in public health management of things like our current pandemic but also future [public health crises] that might happen.”
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