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Owlstone Medical Making Push to Commercialize 'Breathalyzer' Diagnostic Test for Lung, Colon Cancer

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NEW YORK (GenomeWeb) – Owlstone Medical, a UK-based firm developing a "breathalyzer" technology for non-invasive diagnosis of cancer, infectious disease, and inflammatory disease, is gearing up to market its first test to screen patients for lung and colon cancer.

To that end, in June Owlstone Medical announced closing approximately $7M in investment funding, led by the UK's Medtekwiz Advisory, to help commercialize the assay.

In addition, last week the company appointed three new senior executives. "[We want to] build a team that has experience running clinical trials and commercializing diagnostics," Owlstone Medical CEO Billy Boyle told GenomeWeb in a recent interview.

Headquartered in Cambridge, Owlstone Medical is a spin off of Owlstone, a company specializing in the production of chemical sensing and detection technology. Owlstone Medical has built its reputation on its field asymmetric ion mobility spectrometer (FAIMS) microchip-based technology, originally developed through collaborations with the Pacific Northwest National Laboratory and Agilent Technologies.

Owlstone Medical has adapted the FAIMS technology to a "breathalyzer" platform designed to measure specific volatile organic compounds, or chemical biomarkers, in breath to indicate the presence of a particular disease or cancer.

"We call it breath biopsy, a [noninvasive] way to look in the body for these biomarkers," Boyle said.  

Earlier this year, Owlstone Medical started offering research and development services to pharmaceutical companies to use the breathalyzer technology to determine whether a patient will respond to a particular therapy. In February, Owlstone Medical was awarded a contract under the UK's National Health Services' Stratified Medicine Small Business Research Initiative to use its technology to identify ideal therapies for patients with asthma. The contract is expected to reduce emergency hospital admissions by 30 percent and save the NHS £81 million over 5 years.

Right now finding the right treatment is trial and error. A physician will try different treatments and determine the best option based on how the patient responds, Boyle said. "We want to move from trial and error to right the first time," he said.  In addition to working with the UK NHS, the company is also offering these services to companies developing novel therapeutics.

Over the last four years, the company has published studies in several peer-reviewed journals and presented multiple posters on how its FAIMS technology can be used for a variety of medical diagnostics applications.

Currently, the company is focused on developing the breathalyzer into a noninvasive lung and colon cancer screening tool.

This would work by having a patient walk into a primary care physician's office and breathe into the company's ReCiva breath sampler, which has a FAIMS microchip inside. The ReCiva samplers relays information to Owlstone's Lonestar software, which can analyze targeted chemical markers of disease in breath and bodily fluids, such as certain aldehydes and ketones present in lung cancer.

Owlstone's breathalyzer technology fits within a growing market of non-invasive diagnostic tools, such as liquid biopsy. However, Boyle state that there a couple of important distinctions between Owlstone's breathalyzer and a liquid biopsy. "Breath is the least invasive [way to obtain a sample]," he said. It is also a way to capture and concentrate these volatile organic compounds that would require a very large volume of blood in a liquid biopsy test which is not really feasible, he added.

The screening tool Owlstone Medical is developing will be marketed to physicians to aid in early detection of stage 1 lung and colon cancer. It is currently in clinical trials, but Owlstone expects to have it available on the commercial market sometime in 2017. The company decided to focus on these particular cancers because although they both effect a "huge amount of people" the survival rates haven't improved over the past five years, Boyle said.  

Owlstone Medical has to this point been primarily a research instrumentation business, but it have observed through research published by its scientists and by its R&D customers that the tools can pick up chemical biomarkers of disease and cancer with high sensitivity and specificity, Boyle said.

In the most recent peer-reviewed study of Owlstone's technology in cancer, published in September 2014 in PLOS One, researchers led by the Clinical Sciences Research Institute at the University of Warwick were able to use FAIMS to distinguish a volatile organic compound signature present in the urine of colorectal cancer patients from healthy controls with a sensitivity and specificity of 88 percent and 60 percent, respectively. The researchers noted in that study that while this is lower than the gold standard of colonoscopy, it is comparable with current fecal stool testing including the guaiac and immunohistochemical methods.

More importantly, it may be enough to encourage patients to use it as an initial screen due to its completely non-invasive nature. The idea behind the breathalyzer is that patients can give a breath sample as easily as they can get their blood pressure tested, Boyle said. "If you look at colon [cancer] screening, in the US half the problem is to get people to show up for the test. Fifty percent of the people who need to get screened show up," Boyle said. There are also some problems with current screening methods, since colonoscopies are pretty invasive and fecal tests tend to not be as sensitive, he added.

"In all our studies we get feedback from our patients and they say they find it comfortable to give a breath sample. You'd be hard pressed to get a patient say the same thing about giving a blood sample," he said.

Boyle also said that the company plans to continue looking into commercial applications of the technology in other cancers and diseases once it has launched it test for lung and colon cancers.

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