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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Owlstone Medical and UK’s NHS Study Whether Breath Contains Useful Biomarkers That Could Be Used in Medical Laboratory Tests for Multiple Cancers

Owlstone Medical’s breath biopsy platform takes aim at breath biomarkers for an earlier diagnosis of cancer; could it supplant tissue biopsies sent to pathology labs?

For many years, medical laboratory scientists and pathologists have known that human breath contains molecules and substances that have the potential to be used as biomarkers for detecting different diseases and health conditions. The challenge was always how to create clinical laboratory test technology that could use human breath samples to produce accurate and clinically useful information.

Stated differently, breath, the essence of life, may contain medical laboratory test biomarkers that could provide early-detection advantages to pathology groups in their fight against cancer. Now diagnostics company Owlstone Medical—developer of the Breath Biopsy platform—is about to conduct a clinical study in collaboration with the United Kingdom’s (UK’s) National Health Service (NHS) and others to demonstrate the effectiveness of its breath-based diagnostic tests.

Anatomic pathology groups and clinical laboratory leaders know human breath contains volatile organic compounds (VOCs) that can be useful diagnostic biomarkers for medical laboratory testing. Many possible breath tests have been researched. One such test, the urea breath test for detecting Helicobacter pylori (H. pylori), has been in clinical use for 20 years. As part of the test, patients with suspect stomach ulcers or other gastric concerns, swallow a tablet with urea and exhale carbon dioxide that is measured for H. pylori bacteria.

According to an Owlstone Medical news release, the new study, called the “PAN Cancer Trial for Early Detection of Cancer in Breath,” will explore the ability of Owlstone Medical’s Breath Biopsy platform to detect cancers of the:

Current medical care standards call for these cancers to be diagnosed by analyzing biopsied tissue specimens. If Owlstone Medical’s breath test performs well during trial, it could provide advantages over traditional tissue-based cancer testing that include:

  1. A non-invasive approach to finding cancer earlier;
  2. A lower price point as compared to a tissue biopsy cancer test; and
  3. Faster return of test results, since tissue would not need to be collected from patients during surgical procedures and sent to medical laboratories for analysis.

“By 2030, the number of new cancer cases per year is expected to rise to around 22-million globally. Some cancers are diagnosed very late when there are few treatment options available. Non-invasive detection of cancer in breath could make a real difference to survival,” stated Richard Gilbertson, PhD, Li Ka Shing Chair of Oncology, Director of the CRUK Cambridge Center, and Oncology Department Head at University of Cambridge, in the news release.

How the Breath Biopsy Platform Works

The Breath Biopsy platform relies on Owlstone Medical’s Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology, which the diagnostics company explains is a “fast means to identifying volatile organic compound biomarkers in breath.”

Billy Boyle (above), co-founder and Chief Executive Officer at Owlstone Medical, demonstrates the ReCIVA Breath Sampler. “Positive results from the PAN cancer trial could be game-changing in the fight against cancer,” he noted in the news release. “Success in this study supports our vision of saving 100,000 lives and $1.5 billion in healthcare costs.” This technology has the potential to be disruptive to anatomic pathology, which relies on the analysis of biopsied tissue to detect cancer. (Photo copyright: Owlstone Medical.)

Here is how FAIMS works in the Breast Biopsy platform, according to the Owlstone Medical website:

  • Gases are exchanged between circulating blood and inhaled fresh air in the lungs;
  • VOC biomarkers in the body’s circulation system pass into air in the lungs, along with oxygen, carbon dioxide, and other gases;
  • Exhaled breath contains those biomarkers exiting the body;
  • Because it takes one minute for blood to flow around the body, a breath sample during that time makes possible collection and analysis of VOC biomarkers of any part of the body touched by the circulatory system.

One publication compared the capture of VOCs to liquid biopsies, another possible non-invasive cancer diagnostic technique being widely researched.

“The advantage to VOCs is that they can be picked up earlier than signatures searched for in liquid biopsies, meaning cancer can be diagnosed earlier and treated more effectively,” reported Pharmaphorum in its analysis of five technology companies fighting cancer.

As part of the clinical trial, breath samples will be collected in clinic settings with the hand-held Owlstone Medical ReCIVA Breath Sampler (equipped with a dime-sized FAIMS silicon chip). The samples will come from people with a suspected cancer diagnosis who are seeking care at Cambridge University Hospital’s Addenbrooke’s Hospital. To test reliability of the biomarkers, breath samples from patients with cancer and without cancer will be analyzed.

“You’re seeing a convergence of technology now, so we can actually run large-scale clinical studies to get the data to prove odor analysis has real utility,” stated Owlstone Medical co-founder and Chief Executive Officer Billy Boyle, in a New York Times article.

Breath Tests Popular Area for Research

The company’s Breath Biopsy platform is also being tested in a clinical trial for lung cancer being funded by the UK’s NHS. The study involves 3,000 people, the New York Times article reported.

This is not the first time we have reported on Owlstone Medical. A previous e-briefing explored the company’s technology in a study focused on diagnosis of lung cancer (See Dark Daily, “In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer System That Uses Only a Breath Specimen to Diagnose Lung Cancer,” May 11, 2015.)

Breath tests in general—because they generally are non-invasive, fast, and cost-effective—have been the subject of several other Dark Daily e-briefings as well, including those about:

Owlstone Medical’s ability to get backing from Britain’s NHS, as well as investments to the tune of $23.5 million (the most recent coming from Aviva Ventures) is a positive sign. That Owlstone Medical’s Breath Biopsy platform is credible enough to attract such respected collaborators in the cancer trials as the Cancer Research UK Cambridge Institute (CRUK), University of Cambridge, and Cambridge University Hospitals (CUH) NHS Foundation Trust is evidence that the company’s diagnostic technology is considered to have good potential for use in clinical care.

Medical laboratory managers and pathology group stakeholders will want to monitor these developments closely. Once proven in clinical trials such as those mentioned above, breath tests have the potential to supplant other medical laboratory diagnostics and perhaps lower the number of traditional biopsies sent to labs for diagnosis of cancer.

—Donna Marie Pocius


Related Information:

Owlstone Medical and Cancer Research UK (CRUK) Initiate Pan Cancer Clinical Trial to Evaluate Breath Biopsy for Early Detection of Disease New Cancer Detecting Breath Test to Undergo Clinical Trials

Five Tech Companies Advancing Against Cancer

Aviva Invests in Owlstone Medical Breath Biopsy Platform and its Expected Drive Adoption of Breath Biopsy in Healthcare

Owlstone Medical’s ReCIVA Named Invention of the Year in Top 50 Digital Health Awards

One Day a Machine Will Smell Whether You’re Sick

Cancer Breath Biomarker: CRUK and Owlstone Start Multi-Cancer Trail

In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer That Uses Only a Breath Specimen to Diagnose Lung Cancer

Companies Developing Non-Invasive and Wearable Glucose-Monitoring Devices That Can Report Test Data in Real Time to Physicians and Clinical Laboratories

Wisconsin Company Developing Breath-Based Diagnostic Test Technology That Can Detect Early-Stage Infections Within Two Years of Onset

Study into Use of Breath Analysis to Monitor Lung Cancer Therapy Enhances Clinical Laboratories Ability to Support Precision Medicine