Devices & Diagnostics

A new twist on non-invasive cancer detection: breath

Owlstone Medical is working on a breath-based cancer detection system and the hopes is the technology will improve early detection and decrease false positives.

Owlstone Medical's breath-based cancer detection system

Owlstone Medical’s breath-based cancer detection system

 

There are many companies developing non-invasive liquid biopsies for cancer, including genomics giant Illumina.

But Owlstone Medical is taking a different route, working on a breath-based cancer detection system. The company hopes their technology will improve early detection and decrease false positives. They have recently expanded their Lung Cancer Indicator Detection (LuCID) trial, and will recruit around 3,000 patients to validate the technology.

Based in Cambridge, England, Owlstone Medical was recently spun off from Owlstone, which has been developing chemical monitoring systems to meet post-9/11 security concerns. Regardless of the application, both entities use Field Asymmetric Ion Mobility Spectrometer (FAIMS) chips to detect minute traces of specific chemicals. At Owlstone Medical, the chip is being used to analyze volatile organic compounds (VOCs) in breath, specifically metabolites generated by cancer.

“We always knew that one of the opportunities could be medical diagnostics,” said Owlstone Medical cofounder and CEO Billy Boyle in a phone interview. “The thing that makes the technology unique is that you can program what you’re trying to detect just by changing the software.”

The breath contains about a thousand VOCs, most of them perfectly normal byproducts of respiration. However, different diseases produce their own metabolites. The chip is combined with a breath collection (Respiration Collector for In Vitro Analysis) device, and the tandem acts as a programmable filter, specifically targeting compounds of interest.

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“It’s very much like a mass spectrometer on a silicon chip,” said Boyle. “When we sample the breath, we actually pre-concentrate the chemical so every time you breathe on it we store that. Your blood flows around your body once every minute. So in essence, it allows us to sample a large volume of blood for these early stage markers.”

Boyle believes the chip could be a more effective early diagnostic tool than CT scans, which use ionizing radiation and can generate other issues.

“CT has demonstrated mortality benefits, but one of the challenges is the false positives,” said Boyle. “We would hope to have a test that’s just as sensitive but doesn’t have the same incidence of false positives.”

Boyle noted that around 14.5 percent of lung cancer patients are diagnosed with early-stage disease. Owlstone Medical would like to increase that to 25 percent and save thousands of lives in the process. If successful, this technology could carve out a niche in early detection, an area where liquid biopsies have so far come up short.

But Owlstone is not alone.

Like liquid biopsies, the breath analysis space is filling up. Cambridge CMOS Sensors, which like Owlstone spun out of Cambridge University, is also leveraging their gas detection technology to help diagnose disease. Wisconsin-based Isomark is using breath to detect infections. In addition, a number of academic institutions, such as Georgia Tech, are pursuing research on similar technologies.

Still, Boyle cautioned that the clinical applications require more than finding scarce chemicals.

“It’s not just about a single bit of technology; it’s about the backend process to make sure you’re doing robust measurement that’s going to deliver patient benefit,” he said.

Owlstone Medical recently raised $7 million and hopes to launch its lung cancer diagnostic in the U.S. next year and future iterations in the UK and EU down the road. The company envisions a variety of applications for the technology, such as selecting therapies for patients with severe asthma, a process that can rely heavily on trial and error.

“We’re focused on making the LuCID trial successful, but we’re also taking a step back and saying, ‘How can this new technology be deployed in other conditions?’” said Boyle. “This is a new type of test that might benefit patients across a range of diseases.”

Photo: Owlstone Medical