The first COVID-19 diagnostic test using a sample of a patient’s breath has been approved by the U.S. Food and Drug Administration. And the technology comes from a Frisco startup—impressive for a five-person team.
On Friday, InspectIR, a medical device company whose breathalyzer test was initially developed for far different uses, landed FDA emergency use authorization to begin public use of the test as the pandemic continues to ebb and flow across the country.
“As most of us have experienced, the world has changed due to the coronavirus pandemic,” said Tim Wing, InspectIR CEO, at the beginning of the pandemic. “We challenged our development teams with a simple question: ‘Can we help?’ We quickly realized our devices could identify COVID-19 in the breath and help with the unique circumstances facing the U.S. and the world right now.”
100 instruments per day
The technology won’t likely take the place of temperature checks at places like entertainment venues and restaurants, as it’s designed for uses at doctors’ offices, hospitals, and mobile testing sites and is about the size of a suitcase. But the company says it can provide results within less than three minutes and process 20 samples per hour.
The company expects to be able to produce about 100 instruments per week, with each being able to evaluate 160 samples each day. The New York Times reports that Pfeiffer Vacuum would be its initial manufacturing partner, while noting that a timeline for those production figures were not disclosed.
Identifies organic compounds associated with COVID-19
The InspectIR test uses a technique that can rapidly identify organic compounds associated with the virus. According to results from a study of about 2,400 people, the InspectIR breathalyzer correctly identified 91.2% positive samples of COVID-19 and 99.3% of negative samples. That means that the tests are more effective than the rapid antigen tests available for free through the government, but slightly lower than the nearly 100% effectiveness of current PCR tests. However, it is less invasive than the procedures for both.
The tests could be implemented by health care facilities, organizations running pop-up testing, and airports by leasing out the analyzers, the New York Times notes, likely at a cost of about $10 to $12 per test.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”
Initial focus on drug testing
When InspectIR was founded in 2018, COVID-19 was not a part of the national lexicon, nor a part of the company’s original focus, though it has now been focused on combatting the virus for more than a year in a half, in tandem with the FDA. Initially, the company was working with researchers from the University of North Texas on the technology for uses in testing for opioid and marijuana use on driver
InspectIR has developed patented technology through a strategic partnership with Dr. Guido Verbeck and the University of North Texas.
Last year, Verbeck’s COVID-sniffing sensors were put in use by InspectIR when Indoor Football League’s Frisco Fighters partnered with InspectIR to conduct weekly COVID screenings of players and staff. InspectIR was already using Verbeck’s UNT lab’s technology for portable breathalyzers detecting opioids and cannabis, Dallas Innovates reported at the time.
$3M in funding announced
The company has publicly announced raising close to $3 million and has been teasing a $10 million round of funding since 2018.
“(Friday) was a huge domino for us,” Wing told the New York Times.
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