Breath Diagnostics, a Kentucky-based healthcare innovation company, is developing a novel lung cancer detection device that has demonstrated superior efficiency to other technologies on the market.
In an interview Friday, CEO and Director Ivan Lo explained what distinguishes his company and its state-of-the-art technology from the competitors. Currently, Breath Diagnostics is going through the required motions to seek eventual approval from the United States Food and Drug Administration (FDA).
One of the most important stepping stones to achieving this will be completion of an extensive national lung cancer screening trial. Following other comprehensive research, Breath Diagnostics is now working toward bringing this to fruition and making the device commercially available in the healthcare industry.
Because a national lung cancer screening trial will take time, Breath Diagnostics is working to commercialize it’s breath test sooner by developing a Clinical Laboratory Improvement Amendments (CLIA) laboratory developed test.
“We have 10 peer reviewed papers and more patients in our field of breath diagnostics for lung cancer than any other breath analysis or breath diagnostic company,” Lo said.
In a nutshell, the technology is extremely simple and easy to use for patients. All a patient has to do is breathe one breath into a bag, and the company does the rest.
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Greater efficiency, lower costs
Lo explained how the OneBreath analysis system the company has pioneered uses a device called a MicroReactor to stabilize the volatile organic compounds (VOCs) present in a person’s breath through a unique chemical process. This process is unique because, unlike traditional breath analysis methods which use thermal desorption, OneBreath doesn’t require additional sample preparation – such as heat – to release the VOCs for analysis.
Once stabilized on the breath diagnostics MicroReactor, the sample can then be measured using mass spectrometry (both GC-MS and LC-MS). As lung cancer is the most deadly of all cancers, being able to detect it as early as possible is of the utmost importance. The earlier the detection the lower the healthcare costs for patients and providers. Most importantly, the better the patient outcomes.
Breath Diagnostics’ technology has been studied in over 800 patients across three clinical sites.
“Our technology is cheap, it’s easy to use, it’s easily accessible, it’s non-invasive, and it is very safe,” Lo said. None of the competitors are using this innovative method.
The MicroReactor device. Photo: Breath Diagnostics
Superior to CT scans for testing
Low-dose computed tomography (CT) scans is the only FDA-approved screening method for lung cancer available today. While this type of testing has a high sensitivity rate of 94%, it’s also time consuming, expensive, involves radiation, and has a false positive rate of over 96%.
In peer-reviewed studies, Breath Diagnostics’ technology has been shown to achieve a similar sensitivity but a much higher specificity and significantly lower false positives when it comes to detecting lung cancer.
The Breath Diagnostics device merely requires an individual to breathe into a bag. Then, just like a blood sample, it can then be sent to a laboratory for analysis.
It doesn’t expose the test subject to any radiation like a CT scan does either.
“Most importantly, we’re trying to develop something that makes it easy for people to see if they have lung cancer,” Lo said.
In addition to lung cancer, the technology may also be able to detect tuberculosis, pneumonia, COVID and other conditions.
In 2022, Lung cancer was the most commonly occurring cancer worldwide with 2.5 million new cases accounting for 12.4% of the total new cases. It was also the leading cause of cancer death (1.8 million deaths, 18.7% of the total cancer deaths)
cases.https://t.co/dXU2pRrMPZ— Breath Diagnostics Inc. (@OneBreathDx) March 27, 2024
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World-renowned surgeon among founders
Three professors from the University of Louisville and a chest surgeon from Michigan founded Breath Diagnostics in 2015. Medicine, chemistry and chemical engineering are their fields of expertise.
Very notably, founder Victor van Berkel is one of the top lung transplant surgeons in the world and recently participated in the FDA’s Oncologic Drugs Advisory Committee (ODAC) Meeting on July 25, 2024.
Breath Diagnostics is now working on filing a Reg CF to allow interested investors to participate in advancing the field of breath diagnostics and lung cancer. To date, the healthcare tech developer has received funding from the Bill & Melinda Gates Foundation, the Jimmy V Foundation, the Coulter Foundation, and most recently, Wealth Stream Capital Corp.
Owlstone Medical and Breathe BioMedical are some of the competitors working in the field of breath diagnostics. Meanwhile, Freenome, a privately held company developing multiomics blood tests for early cancer detection, has initiated a study intended to validate the clinical performance of the Freenome blood test for lung cancer screening.
In the U.S. alone, the addressable market for lung cancer screening is estimated to be worth more than US$63 billion.
rowan@mugglehead.com
