Breath Biopsy platform features in BioWorld MedTech

Published on: 15 Mar 2018, under Breath Biopsy

The recent investment of $15 million co-led by Aviva and Li Ka-Shing of Horizons Ventures to commercialize the Breath Biopsy platform has been featured in an article by BioWorld MedTech.

Owlstone Medical raises $15M to advance commercialization of VOC breath biopsy tech

By Nuala Moran, Staff Writer

Owlstone Medical Ltd. has raised $15 million to advance commercialization of its volatile organic compound (VOC) breath biopsy technology, providing the means to launch a lung cancer diagnostic and to develop other cancer tests, while expanding the precision medicine arm of its business.

The new money will allow the company to reach a number of milestones, said co-founder and CEO, Billy Boyle. “[They] include bringing our lung cancer breath biopsy test to market, deepening our early detection pipeline – with ongoing trials across multiple cancers – and to further grow our existing precision medicine business,” he told BioWorld MedTech. The round was co-lead by a new investor Horizons Ventures, the private investment arm of Hong Kong business magnate Li Ka-shing, with existing investor Aviva Ventures as co-lead. Other investors also followed on in the financing, which brings the amount raised by Owlstone Medical since it spun out of its parent Owlstone Inc. in August 2016 to $38.55 million.

Owlstone Medical’s diagnostics depend on measuring VOCs in exhaled breath. In the first part of an ongoing lung cancer study funded by the U.K. National Health Service, it was shown that the company’s Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology could detect VOCs at thresholds 10 times lower than previously reported with other gas chromatography techniques. Building on this, the second part of the study aims to validate lung cancer breath biomarkers from samples collected with Owlstone’s breathalyzer, Reciva (Respiration collection for in vitro analysis), in 3,000 patients thought to have lung cancer and who have been referred for diagnostic tests.

Samples collected with the Reciva device are processed in Owlstone’s central laboratory at its base in Cambridge. That part of the study is ongoing. If successful, Owlstone plans to conduct a population-based screening trial.

Proving breath biopsy is a suitable tool for population screening in lung cancer will open the way for similar tests for the early detection of a range of cancers. Owlstone is working with the charity Cancer Research UK to determine the VOC fingerprints for cancers including bladder, head and neck, kidney, pancreatic, breast and prostate cancer (See BioWorld MedTech, July 27, 2017.)

In addition to VOCs in breath, Owlstone is using FAIMS to measure VOCs in urine as the basis of an early diagnostic for colorectal cancer. The company says the kidney’s role in filtering waste products from the blood makes it a good medium for detecting VOC disease markers. Preliminary data from a study in colorectal cancer has shown the VOC signature in urine of patients with cancer can be distinguished from healthy controls, with sensitivity of 88 percent and specificity of 60 percent. That is not as good as colonoscopy, but compares with fecal immunochemical testing (FIT) in use in national screening programs.

Research also has been carried out on noninvasive diagnosis of pancreatic cancer through VOCs in urine. In addition, the technology has been assessed as the basis for diagnosing pediatric inflammatory bowel disease by analyzing fecal VOCs. Owlstone claims the advances it has made in standardizing the collection and analysis of breath samples will create a new diagnostic modality.

“Since the founding of the company, we have established breath biopsy as a new industry category and are confident that the funding will allow us to demonstrate the significant value we can deliver,” Boyle said.

The robustness and accuracy of FAIMS has been established over more than a decade by the parent Owlstone company, which markets the technology for applications including detection of chemical warfare agents, explosives, narcotics and toxic industrial chemicals, and for quality control in food and beverages, pharmaceuticals and water supply industries. Given that, the main task for Owlstone is to demonstrate the VOC fingerprints of different diseases can be defined and distinguished one from the other, and that the metabolites from which they are generated are consistent across patient populations.

Breath biopsy captures VOCs released by the lungs that are a direct reflection of pulmonary disease. But because the lungs are very effective at exchanging chemicals with the blood, breath also provides a snapshot of all the metabolites being released from the bloodstream. Owlstone says that capturing exhaled breath over one minute, the time taken for the blood to circulate all the way around the body, gives a complete metabolic picture.

In addition to cancer, Owlstone is involved in a study where breath biopsy is being used to stratify asthma patients into different subtypes, to inform treatment. There is evidence that different VOC profiles correlate to different inflammatory subtypes, and also that VOC profiles can be used to tell whether a viral or a bacterial infection is the cause of an asthma exacerbation.

VOC analysis is being applied by Glaxosmithkline plc in a phase II study of the anti-inflammatory drug danirixin in the treatment of chronic obstructive pulmonary disorder. In addition to patient stratification, VOC breath biopsy will be used in the assessment of treatment effects. Owlstone now plans to expand the use of breath biopsy in drug development and precision medicine, where it says the technology can provide dynamic information about disease activity and response to therapy.

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