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First FDA EUA for Breath-Based COVID Test in Hand, InspectIR Focusing on Commercialization


NEW YORK – After receiving the first ever Emergency Use Authorization for a SARS-CoV-2 breath test from the US Food and Drug Administration, InspectIR is planning out its next steps toward commercialization and distribution.

The Frisco, Texas-based firm was founded in 2017 with a focus on breath testing for drugs of abuse, but the COVID-19 pandemic led the company to change direction and refocus its efforts on using its technology to develop a test for the SARS-CoV-2 virus, said Tim Wing, the company's cofounder and CEO. After being stuck in lockdown when the pandemic hit the US in mid-March 2020, "we came back and said 'Hey, this is a respiratory illness, [and] we deal with breath … can we help?'" 

By the end of that month, and after consulting with its partners at the University of North Texas, it decided to pivot its focus on developing a breath test for SARS-CoV-2, a decision that culminated last month with the authorization from the FDA. 

The test relies on mass spectrometry to detect five volatile organic compounds (VOCs). The test determines whether an individual may be infected with SARS-CoV-2 by measuring the VOCs that are created by a viral infection as the body responds to the virus, InspectIR Cofounder and President John Redmond said. "The biological pathways in your body's response to viral infection at the … cellular level is what we're seeing." 

The "secret sauce" of the test lies chiefly in the proprietary pre-concentrator it uses to condense the breath into a form where it can be put directly into the mass spec instrument, Redmond said.

Individuals being tested must exhale for between eight and 10 seconds so the device can capture about a quarter liter of breath, but they "don't have to exert a lot of force," Redmond noted. The breath is then heated, treated with a pre-concentrator that isolates the compounds being looked for, and put into the mass spec, called the PNY-1000, which analyzes the biomarkers of the breath and produces either a red light or a green light to indicate the result in less than three minutes. The instrument is portable — able to fit in a 25-inch bag — and has "extremely high" resolution, which improves the sensitivity and allows the test to detect the virus down to the parts per billion, he said. 

Guido Verbeck, a professor at UNT who developed the mass spec and helped with the test's chemistry, noted that "most of this stuff now starts with big data." To create the chemistry, an algorithm was used to determine what compounds are expressed in SARS-CoV-2 patients, and once those compounds are known, you can "work the chemistry backwards" to identify the specific biomarkers to be detected. 

Using a mass spectrometer was the clear choice for this test, Verbeck said, because of the high level of sensitivity. The portable mass spec has already been used for a variety of applications such as environmental monitoring and weapons detection, so the team knew it was sensitive. "The idea was, 'What can we do with these mass specs to help solve this problem?'" he said. Once that was decided, the next question was whether the specific chemistry could be pre-concentrated to use the instrument for SARS-CoV-2 detection. 

In the clinical trials done for its EUA submission, the company tested more than 4,000 people, both symptomatic and asymptomatic, from multiple regions in the US and tested for cross-reactivity. The firm also conducted a small study looking at the Omicron variant, with Redmond saying that the "chemistry is the same, the biological response, so it doesn't really matter" what the variant is. Based on those trials, the developers determined the test has a sensitivity of 91 percent and a specificity of 99 percent. 

Now that the test has been authorized for marketing, the company is focused on commercialization. The manufacturing partner for the instruments is Pfeiffer Vacuum, although the firm could end up working with additional manufacturers down the line, and the firm is going to use an equipment leasing structure, Wing said. Currently, the company has a capacity of about 500 devices per month, but it plans to continue to ramp that up as demand grows. While there's no distribution partner yet — in part because the company was so focused on developing the technology and getting regulatory approval — InspectIR is planning on selling the test directly to businesses, while also utilizing strategic partnerships, Wing said. 

The test can't use the specific term "point-of-care," at least in the view of regulators, because breath as a sampling type has never been approved before, Redmond added. However, the company is allowed to "go where testing needs to go, as long as a licensed healthcare professional is directly observing" the process. That might mean airports, clinics, hotels, or doctors' offices — pretty much "places where people gather are going to make sense." Redmond also noted that, because of the cost and the technicality of the instrument, it makes sense for the test to be used only for high volumes. 

"The things that we kind of focus on are community and fellowship and getting groups back together," Wing said.

Redmond, Wing, and Verbeck are the US patent holders for the pre-concentrator and instrument, and they have applied for patents outside the US, Redmond said. The intention is to eventually expand beyond the US, and the company has been getting calls from groups in other countries, such as China, Japan, Germany, and Brazil, expressing interest in the test.

InspectIR is also preparing to submit the assay for 510(k) or de novo clearance with the FDA, although the path ahead is tricky because there is no predicate device for the test, Redmond said. The firm's next conversation is with the Centers for Medicare and Medicaid Services to determine reimbursement rates — another potentially difficult proposition due to the lack of a preceding technology. However, Redmond said they expect the price of an individual test to be "roughly equivalent" to rapid antigen tests.

Although InspectIR has made it to the FDA altar first, other companies and research teams are also working on breath tests for COVID-19. Finnish company Deep Sensing Algorithms received CE marking for its COVID-19 breath test in January, while Singapore-based Breathonix nabbed the CE mark for a breath test using mass spectrometry in November.

However, developing a breath-based test isn't easy, which is likely why it took more than two years for the first COVID-19 breath test to reach the FDA's doorstep. Canary Global, headquartered in Canada, had a breath test for SARS-CoV-2 in the works back in December 2020, but pivoted to saliva testing due to fears of cross contamination and the longer regulatory pathway for breath testing, Anna Wang, Canary's senior VP of corporate affairs, said via email.

In addition, "because the tests were designed with single-use cartridges that contained nanosensors, they were also more expensive to make, especially with the world shortage of sensors and chips." The company "felt that such a breath test may not be competitive from a pricing point when the market has been flooded with lower-quality cheap rapid tests."

Expanding beyond COVID-19, which Wing noted is still a global challenge, this test "is just the tip of the iceberg" for the company. He believes it will "lead to a swell of new measurements and new tools" for different diseases, like influenza and respiratory syncytial virus, that the firm can expand to, as well as an opportunity to return to its roots of drug testing. 

Verbeck echoed his thoughts, saying that the "idea of using breath to diagnose disease" isn't new, but he hopes InspectIR's EUA "opens the door to more" uses for the technology. "I just think this thing's going to blow up," he said. "It's a bit of a paradigm shift."