OWhen the first wave of states began legalizing medical and recreational marijuana in the 2010s, Tim Wing and John Redmond envisioned a cannabis breathalyzer that could analyze samples in minutes without sending them to a lab. , similar to those the police use to check for drunkenness. Drivers. Bootstrapped with $2.7 million cobbled together by family, friends and a handful of angel investors, the pair had the vision but lacked the chemistry credentials. To address this skills gap, they partnered with University of North Texas chemistry professor Guido Verbeck to develop what Wing calls a “chemistry lab in a box.”
When the pandemic hit in March 2020, CEO Wing, 49, and President Redmond, 51, co-founders of Frisco, Texas-based InspectIR, switched from cannabis to Covid. Two months later they started a clinical trial, and Thursday, hardware and software for this portable chemistry lab — the size of a 40-pounder. carry-on suitcase – received the first emergency use authorization from the FDA for a breathalyzer to detect Covid-19.
The hours since FDA clearance have been a whirlwind for the duo, who first met in 2008 when they were paired at a golf tournament in Texas, where the two midwestern transplants hit it off immediately. Wing has spent the past two decades as a sales and marketing entrepreneur from the early days of the internet, while Redmond has worked in human capital consulting, primarily talent acquisition and diversity, in technology. . After their first venture, an imaging company focused on remote non-contact temperature measurement, fell through, they launched InspectIR in 2017. “We started and fought like hell,” said Wing. Forbes.
Their device is based on an existing technology, the miniaturized mass spectrometer. When a person exhales, they exhale a cocktail of organic compounds, including oxygen, carbon dioxide, and nitrogen. The spectrometer breaks down molecules of organic compounds and sorts them by size. “With viral infections, we know that the body creates a chemistry, or an outgassing, based on its response to fighting the virus inside our body at the cellular level,” Redmond explains.
This means that the breath of someone infected with Covid-19 will deteriorate differently from the breath of someone who is not infected. The device identifies a specific “signature,” a mixture of certain compounds that the SARS-CoV-2 virus generates in exhaled breath. The exact signature is proprietary, says Redmond, but what the device is looking for is a specific mix of aldehydes and ketones. Although the mass spectrometer is not new, Wing, Redmond and Verbeck patented the process by which breath is collected, known as the pre-concentration stage.
The time to get a result is about three minutes and the machine can perform an average of about 20 tests per hour.
JThe InspectIR handheld device will not be available in stores anytime soon. The business plan is what Wing calls “testing as a service”. The company will license the device to healthcare facilities, employers, event venues and anywhere where a large number of people need to be screened for Covid in a short period of time. To pass the test, a person blows into a straw on the side of the device. The time to get a result is about three minutes and the machine can perform an average of about 20 tests per hour. In addition, a quick exhale is much more comfortable than a tampon in the nose.
Currently, InspectIR directly employs only five people, not including its relationship with the University of North Texas and its researchers. The devices are currently being manufactured through a partnership with Pfeiffer Vacuum, at a factory in Carmel, Indiana, and the company expects production to be around 100 units per week, which will increase as sales begin. Prices are also being worked out, but Redmond says they’ll likely be comparable to rapid antigen tests currently on the market, which cost around $10 to $12 per test.
The main benefit for consumers is twofold: first, there is no nasal swab. Second, the tests have also proven to be very accurate. Results of a study of over 2,400 people FDA submitted found the test correctly identified positive Covid-19 results 91.2% of the time and negative results 99.3%. “The FDA continues to support the development of new Covid-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the United States for the next public health emergency,” said said Jeff Shuren, director of the FDA’s Center for Devices. and Radiological Health, said in a statement following the clearance.
Like other rapid Covid tests, any positive result would need to be confirmed with a PCR test. “We are on the front line,” says Redmond. “If you get a negative result, you’re good, keep going. If you get a presumptive positive result, you have another test to do.
Wing and Redmond will then focus on responding to the hundreds of emails they’ve received since FDA clearance, customer signings and ramping up production. Now that the device has been validated for Covid-19, InspectIR plans to conduct studies in other respiratory diseases and will eventually return to the original use cases.
“It opened up a whole world on the medical device side,” says Redmond. “Because one of the challenges when we talk to people, almost instinctively, they ask, ‘Is this FDA cleared? Well, now the answer is yes.