Cambridge-based Owlstone Medical was spun out of Owlstone Inc. in 2016 to develop medical applications for its proprietary microchip chemical sensing technology, Field Asymmetric Ion Mobility Spectrometry (FAIMS), which is used in the military and industrial sectors globally.

Owlstone Medical’s unique breathalyser for disease, the ReCIVA Breath Sampler, collects breath samples reliably and reproducibly, which are analysed for volatile organic compounds (VOCs) as biomarkers for a range of diseases using the company’s Breath Biopsy services and products including the FAIMS microchip chemical sensor. The Breath Biopsy® platform has the potential to revolutionise healthcare by making non-invasive breath tests a reality for various diseases. The company aims to save 100,000 lives and $1.5 billion in healthcare costs.

Early detection has the greatest potential to improve patient survival rates. Currently, only 9% of patients with colon cancer are diagnosed at Stage I, where five-year survival rates are around 90%, compared with less than 10% for those diagnosed if the cancer has metastasised (Stage IV).

The concept of using breath to diagnose disease has been recognised since Nobel laureate Linus Pauling’s pioneering work in the 1970s. However, the application of breath biomarkers in medical diagnostics has been hampered by the lack of a device to collect breath samples in a reproducible way. The ReCIVA Breath Sampler, inspired by discussions with more than 100 experts in different fields, from design engineers to clinicians, is the first technology capable of capturing breath samples in a systematic way suitable for large-scale clinical trials.

Development of the ReCIVA Breath Sampler to this high accuracy and precision involved detailed engineering design and manufacture throughout - from the patient interface, to the use of sophisticated software and control systems as well as materials. Given that potential contaminants present a huge challenge in breath sampling, innovation was even required in the pre-treatment of the components used to capture the breath in the first instance.

Owlstone Medical has initiated the world’s largest breath-based studies trialling the Breath Biopsy® platform with the NHS and Cancer Research UK across several cancer types. The most advanced of these, the LuCID Lung Cancer Trial, is recruiting up to 4,000 patients across 26 clinical sites in multiple countries.

As well as diagnosis, breath biomarkers have potential in precision medicine, where they can provide information that could identify patients most likely to respond well to a particular therapy. GSK recently chose to integrate the Breath Biopsy® platform into the clinical development programme of one of the novel drug candidates in their respiratory disease pipeline, to assess whether the right patient for the right treatment can be identified. Non-invasive tests are especially welcome where it can be challenging to obtain invasive samples like blood, for patients such as children. Owlstone Medical has received CE mark approval for a paediatric version of the ReCIVA Breath Sampler and extends the scope of breath testing to include children as young as five years old.

Owlstone Medical’s Breath Biopsy® clinical laboratory is a unique, revenue-generating facility that allows pharmaceutical, clinical and academic partners worldwide to explore breath-based biomarkers to optimise their own investigations into precision medicine. This is expected to provide Owlstone Medical with a significant royalty stream as they work towards making breath-based precision medicine a reality. The company has raised a total of $38.5 million in equity financing, and is backed by investors including Aviva, a leading healthcare insurer, as well as technology investor Horizons Ventures.

The Breath Biopsy® clinical laboratory is based in Cambridge, in addition to its manufacturing and R&D sites, with an impending move to new larger premises locally. The company has rapidly expanded and now employs over 120 people in Cambridge. The company has recently launched a range of new Breath Biopsy Kits and will announce new partnerships with biopharma by the end of this year.

MacRobert Award Judge Professor Sir Saeed Zahedi OBE FREng RDI, Technical Director of 2016 MacRobert Award winner Blatchford, said:

“Healthcare systems will need to innovate to cope with the pressures of an ageing global population, reduced healthcare budget, an increase in cancers and infectious diseases and targeting effective outcomes for patients. Owlstone Medical’s innovation not only allows academics, clinicians and pharmaceutical companies to explore breath-based diagnostics for their own clinical applications, but also shows promise in bringing a new simple, cost effective diagnostic tool for key diseases to the market.

“With $400 billion a year wasted on ineffective drugs, there is a global move towards precision medicine – ensuring that the right intervention and drug are given to the right patient at the right time. This technology also has the potential to improve patient outcomes through early detection and reduce healthcare costs through easy precision sampling of breath and analysis in local labs.

“The future road map of this innovation in medical device technology is transformative and could be the key for future self-diagnostics as part of a long-life care revolution.”

The nominated team members are:

  • Billy Boyle, Co-founder & CEO
  • David Ruiz-Alonso, Co-founder & COO
  • Max Allsworth, Chief Scientific Officer
  • Alastair Taylor, VP of Engineering
  • Matthew Hart, VP of Research and Development