Breath Biopsy PAN Cancer Trial in BioWorld MedTech

Published on 31 Jul 17, under Breath Biopsy, Cancer, Clinical Trials, Media Mentions

The PAN Cancer trial, initiated by Owlstone Medical in collaboration with a team of leading cancer researchers at Cancer Research UK (CRUK), has been featured in an article by BioWorld MedTech. The article describes how the large scale clinical trial will evaluate the use of Owlstone Medical's Breath Biopsy platform for the early detection of multiple cancer types. You can read the article below:

Cambridge tests breath biopsy

Owlstone joins Cancer Research UK in breath-taking hunt for cancer biomarkers

By John Brosky, Contributing Writer

Breaking with the established wisdom for start up companies to sharply focus on executing a single mission, London-based Owlstone Medical Ltd. is launching a scatter gun strategy broadly aimed at every cancer known to scientists at England’s prestigious Cambridge University.

The PAN Cancer Trial centers on Owlstone’s unique, Reciva breath sampler that captures volatile organic compounds (VOCs) exhaled from the lungs, which can then be analyzed to identify biomarkers that signal disease.

The shared mission in the collaboration with leading cancer researchers at the Cancer Research UK (CRUK) Cambridge Center is to validate breath-borne biomarkers for the early detection of cancer. With CRUK, the PAN Cancer Trial will sniff out the diagnostic potential of the ReCIVA device for bladder, breast, head and neck, kidney, esophageal, pancreatic, and prostate cancers and brain tumors.

Supporting this breath-taking sweep of research are the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust.

Owlstone already has two trials underway to validate biomarkers it has identified for lung and colorectal cancer. (See BioWorld MedTech, Oct. 5, 2016.)

Patients with a suspected cancer referred to Addenbrooke’s Hospital on the standard NHS cancer care pathway will be asked to give a breath sample in addition to routine tests. These samples will be carted across campus to Owlstone’s Cambridge facility for analysis of the captured VOCs using its breath biopsy platform, which has demonstrated a high sensitivity and selectivity across a range of diseases. The breath samples of patients with, and without, cancer will be assessed to determine whether reliable biomarkers for early diagnosis of cancer can be identified.

“No one has undertaken a study of this scale, to understand potential biomarkers across as many cancer types” Owlstone Medical CEO Billy Boyle told BioWorld MedTech. “There have been a lot of smaller, piecemeal studies. We are the ones bringing it all together, to get the best understanding of how breath biopsy and VOCs can be used in the detection of multiple tumor types” he said.

The chief investigator for the PAN Cancer Trial, Professor Rebecca Fitzgerald, called the program “a flagship initiative of the CRUK Cambridge Center that aims to devise better means of detecting cancer and diagnosing it in the early stages, which can lead to improved outcomes for cancer patients.”

The trial will begin with a pilot phase.

“We are still designing clinical protocols as there are different tumor types, and different patient populations. Once this first step is completed it will inform planning for a larger study. What will determine how fast a given study can go will be how many patients come through the doors at the clinic,” said Boyle.

Created as a spinout from Owlstone Inc. in 2016 to focus on medical applications for a novel chemical detector developed at Cambridge, Owlstone Medical holds several advantages in tackling the ambitious PAN Cancer Trial.

“The company was commercial from day one,” said Boyle, generating a revenue stream from the CE marked Reciva device for capturing VOCs, as well as sales of the instrument and consumables for analysis.

Owlstone also generates revenue from collaborative partnerships with pharmaceutical companies utilizing its technology to monitor patients in drug trials for asthma and chronic obstructive pulmonary disease (COPD). And six months after its start up, Owlstone Medical had raised £19.3 million (US$23.5 million) through private placements.

Meanwhile the parent company has a thriving business for chemical detection with governments, academic centers, major companies in pharmaceutics, oil, food and beverage, or security, such as the United States Department of Defense and the U.S. Army.

According to Boyle, “Breath biopsy is a new modality, so the logic of what we are trying to do here is to get as much of a detailed understanding of the biomarkers for multiple cancers, disentangling which biomarkers relate to cancer more generally versus those which have some specificity to identify the cancer site.”

“When you look at breath, you see thousands of chemicals, and you wonder where all this is coming from. Some come from the airways, but 80 percent of them come from the blood. Our lungs are very good for exchanging oxygen and carbon dioxide, but also for expressing volatile organic compounds,” he said.

“Blood is the key in all of this. Cancer has an altered metabolism even at early stages, there are metabolites being produced and passed into the blood. The smallest components can pass from the blood to the airways,” he said.

The VOCs in the breath sample are captured by an absorbent material packed in metal tubes for handling. Once loaded in the analyzer instrument, the material is heated to free the VOCs, which are studied using the company’s proprietary Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology, a method of distinguishing charged gaseous molecules under the influence of an oscillating electric field.

He said the company’s heritage working with leading global organizations means it has the knowledge and experience with the technology to maintain good stability and repeatability over time.

Breath biopsy belongs to the next generation of metabolomic lab diagnostics where no sample preparation is required, no clinical chemistry needed to precipitate a reaction with reagents, and the process boils down to pure data.

“The real discovery work is happening at the software level. The team of data scientists we have is our fastest-growing group, the ones who are able to turn raw data sets into meaningful information about what markers or set of markers may be related to a specific disease,” said Boyle.

He acknowledged that, “The limitation is the compounds need to be volatile, they need to be expressed on the breath. There are some areas where breath sampling will not work, those elements of the blood that will not be volatile.”

Here there is a need for a blood-specific analysis, he said.

“We don’t believe there is one magical technology that is going to solve all the problems. Breath biopsy is one approach. Liquid biopsy markers have a role to play, NMR (nuclear magnetic resonance) with urine samples has a role to play as well,” he said. (See BioWorld MedTech, July 25, 2017.)

“We all know the destination we are trying to get to, which is the early detection of cancer, and taking different approaches creates a higher probability that we will get there,” he said.

Click below to download a pdf of the Bioworld MedTech article:

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