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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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If the clinical study validates this patient-friendly, non-invasive approach to diagnosing lung cancer, it could eventually mean fewer referrals of tissue biopsies to medical laboratories

For almost a decade, pathologists have seen a regular stream of news stories about technologies that utilize a sample of human breath to diagnose a disease or health condition. Now comes news that just such a diagnostic test for lung cancer is beginning clinical trials in the United Kingdom.

The clinical trials will evaluate breathalyzer technology developed by Engineer Billy Boyle, M.S., Co-founder and President of Operations at Cambridge-based Owlstone Ltd.. The clinical trials of this new breathalyzer technology to detect lung cancer are taking place at two National Health Service (NHS) hospitals: University Hospitals of Leicester and Cambridge’s Papworth Hospital in the United Kingdom.

The reason why so much research is happening in this field will be familiar to clinical laboratory managers and pathologists. Use of volatile organic compound (VOC) biomarkers in breath to diagnose disease is an ideal concept because it is convenient, non-invasive, and well tolerated by patients. However, until the start of this clinical study, researchers have explored the potential of this diagnostic approach for some time, but with limited success.

Owlstone new diagnostic breathalyzer technology

Could breath specimens be a new source of work for medical laboratories? In the United Kingdom, a Phase I clinical trial of Owlstone’s new diagnostic breathalyzer technology (pictured) accurately identified 12 lung cancer biomarkers in breath specimens. Now a Phase II trial is targeting development of a small, handheld breathalyzer that can be used in the doctor’s office and clinics or at the bedside in hospitals. (Photo copyright Owlstone Ltd.)

New Breathalyzer for Lung Cancer Awarded £1M for Clinical Trial

The clinical trials were launched by Owlstone’s LuCID (Lung Cancer Indicator Detection) project, a consortium of leading academic institutions and clinical partners. LuCID was awarded £1 million (one million British Pound Sterling is equivalent to U.S. $1.5 million) by the NHS Small Business Research Initiatives (SBRI), to fund research of the device’s potential to detect lung cancer early, according to an Owlstone press release. SBRI funds academic and private medical research projects, similar to the U.S. National Institutes of Health.

Lung cancer survival is 75% in Stage 1 patients, versus 5% in Stage 4 patients, according to Cancer Research UK statistics. The goal of this project is to save 10,000 lives by 2020 and £254 million in NHS healthcare costs by enabling the earlier detection of lung cancer. In the UK, lung cancer affects 43,000 citizens annually. Currently, only 14.5% of lung cancer cases are diagnosed in Stage 1, according to the NHS.

Billy Boyle, M.S.

Engineer Billy Boyle, M.S. (pictured above) is Co-founder and President of Operations at Cambridge-based Owlstone, Ltd. He developed a nanochip sensor that accurately detects 12 lung cancer biomarkers in breath. This advancement in diagnostic breath test technology may open the door for diagnosing other cancers and diseases using a breathalyzer test. (Photo copyright Owlstone Ltd.)

Nanotechnology Device Invented by Engineer Affected by Cancer

Boyle invented an inexpensive, chemical sensor on a silicon chip that rapidly detects a broad range of chemicals. The dime-size, nanotechnology device employs Field Asymmetric Ion Mobility Spectrometry (FAIMS) to detect chemicals at the very low quantities found in breath.

Boyle originally invented the device to detect explosives in airports and on battlegrounds, but switched gears when his wife was diagnosed with cancer in October 2012. He refocused this technology’s potential for medical diagnostic applications, noted a Sky News report.

Commenting on the financial award to fund the clinical study, Boyle said: “If you could change only one thing in the fight against cancer, it would be to detect the disease earlier where existing treatments are already proven to save lives. FAIMS technology has the potential to bring a quick and easy-to-use breath test to a GP’s [general practitioner’s] office,” he added. “Our team will not rest until we help stop the daily devastation that cancer brings to patients and their families.”

“We already have the microchip,” Boyle continued. “We’re working on small handheld devices in [a] GP’s office. It’s important to get the clinical evidence first, but we think we can have systems available, proven, within the next two years.”

Device Accurately Detects 12 Lung Cancer Biomarkers in Breath

A Phase 1 clinical trial has already demonstrated that Boyle’s sensor accurately detects 12 lung cancer biomarkers in breath specimens. The SBRI funding for Phase II will be targeted towards delivery of a small, handheld breathalyzer for use in a doctor’s office or hospital, and clinical validation of the method.

“The human body makes chemicals: a lot of them are just normal, everyday chemicals, but with cancer and other diseases the cells go a bit wrong and start to make chemicals differently,” Boyle explained, in an SBRI press release. “So, by programming the chips in software to look for these different characteristic signatures and chemical markers, you can program it to look for a range of different diseases.”

Technology May be Applicable to Other Diseases

Already, there’s speculation that the device could be applied to detecting other diseases too, including bowel cancer, tuberculosis, and asthma, noted the Sky News report. Meanwhile, researchers have also found evidence of biomarkers in breath for breast cancer and abnormal mammograms, as well as Chronic Obstructive Pulmonary Disease.

Pathologists and clinical laboratory managers are familiar with the urea breath test that has long been in use to detect Helicobacter pylori (H. pylori). This is a type of bacteria that infects the stomach and duodenum, and is a main cause of ulcers in these areas. H. pylori produces an enzyme called urease, which breaks urea down into ammonia and carbon dioxide. Patients swallow a tablet containing urea. The amount of carbon dioxide exhaled is measured to detect H. pylori in the stomach.

Dark Daily has published many e-briefings over the years on breath testing (see list below). It is well known that volatile compounds are in the breath. Many companies have announced research and the development of instruments to analyze breath to detect disease. However, to date, nothing practical has come to market, outside of the H. pylori test described above.

Thus, the fact that the UK’s NHS is willing to fund a clinical trial of a breathalyzer device for early detection of lung cancer is evidence that ongoing improvements in this technology have reached the point where clinical applications are feasible.

Since the use of breath specimens is non-invasive and does not require a tissue biopsy to diagnose cancer, any expanded clinical use of this and similar technologies has the potential to reduce the volume of biopsy collections collected and referred to histopathologists for the diagnosis of cancer. What may be the more interesting question is whether, in the case where a breath specimen has resulted in a diagnosis of lung cancer, the patient will then need a tissue biopsy in order to identify gene mutations that may be useful targets for specific therapeutic drugs. In such cases, pathologists will continue to have an important role in helping oncologists select appropriate therapies for their cancer patients.

— Patricia Kirk

Related Information:

Lung Cancer ‘Breathalyzer’ To Go On Trial

The Urea Breath Test and H. Pylori

Cancer Breath Test Device on Trial 

Owlstone’s LuCID Project Wins £1M NHS Funding to Save Lives by Improving Detection Rates of Early Stage Cancer

Volatile Biomarkers in the Breath of Women with Breast Cancer

Biomarkers in Exhaled Breath Condensate and Serum of Chronic Obstructive Pulmonary Disease and Non-Small-Cell Lung Cancer

Researchers Determine That Individual ‘Breathprints’ Are Unique; May Have Potential for Clinical Laboratory Testing When Coupled with Mass Spectrometry Technology

In Clinical Trials, Breath Test for Lung Cancer Shows Promise for Earlier Detection

Researchers Want to Introduce Breath Analysis into Clinical Pathology Laboratory Testing

Detecting Cancer via a Patient’s Breath and Lasers