Owlstone Medical - Part 1

This is an article about Owlstone medical. Who are they? What do they want to achieve? How did they get there? This is a two parter, the first article being the entrepreneur’s journey from the founders perspective, the second being focused on the product and technological innovation. See Billy Boyle’s interview with Paul Tunnah for more information – Link for interview

Billy Boyle displaying the Breath Biopsy device for VOC Biomarkers

Brief summary of Owlstone Medical

Billy Boyle grew up in Ireland and studied engineering at Cambridge University. He was interested in gas sensing. With the problem ‘How you could use microfabrication techniques to make devices smaller, cheaper better?’ Incorporating the company Owlstone Inc in 2004 formerly known as Tiger Dawn Ltd. They raised $ 75M, from US and UK governments and US based VC to develop the sensor technology. The original FAIMS (Field Asymmetric Ion Mobility Spectrometry) chemical sensing technology was developed for high-sensitivity detection applications and was a profitable business selling to military and industrial customers globally.

Sadly, in the mid-2010s, Billy’s wife was diagnosed with colon cancer. In 2016 Owlstone Inc mission shifted with the aim to save 100,000 lives and $1.5B in healthcare costs by building better medical applications.

They changed what they detected by changing the software. It was academic researchers who pushed them to go into looking at breath for disease. The results looked good, from colon cancer to asthma. As of now they have grown to a team to 170 and raised 100 million dollars of investment.

Moving from academia to the commercial side

There is a very supportive community in Cambridge. Which enabled them to evolve the business model from making chips to instruments and then trying to sell into defence and security applications market. In those markets there is a lot of regulatory considerations. It matured the technology but also allowed them to create a very good understanding of ability to measure different VOCs (Volatile Organic Compounds). Once they transitioned into the medical business the challenge was very different, creating medical devices and running clinical trials.

“Breath analyse is something that people have been talking about for a while. If it’s so simple where are all the tests? There are some basic foundational issues, how do you get a good sample?” – Billy Boyle.

Their experience in looking at low concentrations of gas allowed them to deal with getting better samples. This also aided with core biomarker discovery and validation technology. All of the studies were initially small pilot studies and hadn’t been validated on larger studies. In order to do this, they’ve had to build a very strong and capable GC-MS facility to help with this. Larger scale studies were continually thought about from the outset. Focusing on 3 key areas, lung cancer, liver disease, respiratory disease. Diagnosis and disease progression.

“Is there a clinical need, is there a reasonable biological rational, if so, run the study’s.”

Challenges of changing diagnostic pathways

Though they have commercial research and profitable products business. Academic partners have their own interests as well. Academic research has greatly helped showing whether VOCs work in one area compared to another. Allowing them to focus on areas with a real clinical need. However, you still need to overcome all the regular hurdles towards adoption like research, production and services.

“Serendipity plays a great role; you don’t know what applications VOCs may have in the end. Put their investments in what they think are the best bets.”

Funding and Growth

Owlstone Medical has raised significant investment over the years to scale its platform and clinical programmes.

• 2017 Aviva ventures increased its funding to $23.5 M, helping accelerate work on cancer and disease detection technologies (link)

• 2021 Owlstone Medical announced the close of its Series D financing round. Due to the high level of interest the company exceeded its $50 M target raising $58 M by investors Horizon Ventures (link)

• Jan 2025 announced a $ 27 M series E financing round and saw investment from the Gates Foundation (link)

• Oct 2025 Owlstone Medical Wins up to $49.1 M award from ARPA-H to develop at-home multi-cancer early detection tests (link)

  
  

Ambitions

Early cancer detection has the largest risk but all the largest pay off both for the patient but commercial business success. But you do need time and large scale clinical trials. Currently they have good data in liver disease. For respiratory disease they recently launched a research use-only panel there and have done a lot of studies for customers like GSK and AstraZeneca and academic groups as well. There’s lots of interest around digestive health like looking at methane and hydrogen + VOCs, volatile fatty acids for gut health.

Reimbursement

“We can’t think about the risks in a sequence, in the past was can we get the technology working, can you see examples, can you increase the amount of compounds you see on breath and discovery. Does it look like there’s a genuinely valuable biomarker here with breath. How do we make sure we address the question, of reimbursement and appropriate regulatory strategy.”

Ultimately this comes down to linkage to care, it’s imperative to think about clear applications, managing diseases. High sensitivity and specificity. How do we treat the patient, what is the cost and what is the benefit? With things like respiratory diseases there does tend to be a more commercial benefit when the patient is further along and taking expensive biological drugs and you have a high non-responder rate. Still a small patient population is what you’d being doing the test on. Early on you’d want to know that a patient has a particular inflammatory subtype and then give them a drug that has an effect on the outset. It’s hard to do as there’s a lot of trial and error. Assuming drugs on the market, how do you determine patients are improving and not getting worse. Progression over time is important.

Company Location and Impact of COVID

There is the temptation of moving to the US to keep growing. As they’re in Cambridge. It’s very multidisciplinary they have to look at collection devices, reduce amount of VOC ingress that may get into a sample, you also need high end analytical instruments, chemists, data scientists and biologists to understand it.

Covid made some of the cross Atlantic work easier. As they have a team in the US both on the sales side and on the science and engineering side as well. Breath biopsy lab is in Cambridge UK, and they anticipate opening a US based lab.  Covid has had both positive and negative impacts on them as a business. Trials were put on pause, however, it highlighted the necessity of life sciences and diagnostics.

Breath is a complex matrix, you have VOCs but also droplets and aerosols, that’s the transmission mechanism for the virus so there’s a lot of active research in tings like proteins and non-volatile metabolites, bacteria and viruses as well. Longer term trends, digestive health a need for the test kits to go out to the patients. Breath samples can be collected samples in a home setting in a way that you can’t with blood.

Another observation about COVID came from CT scans of people on the cruise ships, high proportion of people who were asymptomatic still had some observable lung damage. The things that aren’t going to change is that 1 in 2 people will get cancer, the vast majority of people will be diagnosed at late stage. For work about breath, for different histology’s 90% of stage one cancers have the mechanism that they’re targeting. Here they’re using their EVOC probe as an approach for this.

Typical day as CEO

Bring in the right people, with the right experience at the right time. The biomarker questions and the key applications that they’re focused on. What are the experiments, studies and trials that are helping to move the needle. Research product and services, pushing the performance envelope, maximise compounds you can see repeatedly on breath, then your chances of finding the biomarker should exist is higher. Pushing that performance, helps with customers and keeping them competitive over time.

Mistakes

He says he’s made plenty of mistakes. One surprising thing is how long it takes. If you have a 12 month experiment, things happen, unexpected result or data doesn’t make sense. Roll with it and have an updated plan. There’s a large degree of impatience; problem needs to be solved but you need a balance that things are working as they should be.

Conclusion

Overall, this was a really informative interview with Billy Boyle and his reasons for pursuing this technology strongly resonated with me. It contains a wealth of information as well as further questions. Why did they choose breath and not urine? What were the trials saying? This is especially a concern of mine as I have determined urine to the be the matrix I aim to use.

However, 2 months prior to writing this article, Owlstone Medical won a $50 M contract from ARPA-H. This program requires team to identify 30+ stage 1 solid tumours using only breath or urine samples as part of a Multi-Cancer-Early Detection (MCED) testing system (link). The other three teams are focusing on urine as well highlighting the strength and need for this technology (link).