A Frisco startup managed to score support and authorization for Breathalyzer, a test that is three times more effective than a normal rapid antigen test according to a Bloomberg article from April 15. They say,
“A Covid-19 breathalyzer test with the ability to provide diagnostic results in three minutes has won emergency-use authorization from the U.S. Food and Drug Administration, the agency announced Thursday.
The test, made by Frisco, Texas-based InspectIR Systems, is authorized for those 18 and older and in settings where samples are both collected and analyzed, such as doctor’s offices, hospitals or mobile testing sites. The device is about the size of a piece of carry-on luggage, the FDA said, and works by detecting chemical compounds in breath samples associated with SARS-CoV-2 infection.
The company, which focuses on portable opioid and cannabis detection tools, expects to be able to produce approximately 100 of the devices each week, which can be used to evaluate about 160 samples per day. On its website, the company says the breathalyzer is the first such device available for commercial use.
The breathalyzer’s success came from continuous studies even though it was not initially planned by the company back in 2019 according to a Dallas Innovates article from April 18 which reports,
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.
“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.”
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.”
Currently, the company will be having almost $10 million funding for the breathalyzer after its success and the eventual support from the government.