Trial of breath test for early cancer diagnosis starts in UK

Patients are now being recruited for a clinical trial of a device that promises to diagnose cancer from a simple breath test, potentially hastening detection and treatment.

The new study is being run by Cancer Research UK and is testing a device developed by Cambridge biotech Owlstone Medical that measures volatile organic compounds (VOCs) in the breath. As cancer alters the metabolism of cells, Owlstone thinks it will be possible to identify multiple tumour types based on the ‘snapshot’ of VOC biomarkers detected.

It sounds simple in theory, but in practice VOCs can come both from the body itself as well as external sources such as diet, prescription drugs and environmental exposure. Owlstone’s Breath Biopsy device (pictured above) will have to identify distinctive patterns from upwards of 1,000 VOCs known to present in the breath.

The 1,500-subject trial will therefore measure samples from healthy subjects as well as patients treated at Addenbrooke’s Hospital in Cambridge who have been referred from their GP with suspected cancers to try to build a database of VOC signatures.

Initially, recruitment will focus on oesophageal and stomach cancers and will expand to prostate, kidney, bladder, liver and pancreatic cancers in the coming months. Patients will give a breath sample ahead of other diagnostics for their cancer, which will allow Owlstone’s device to be assessed alongside standard testing.

Results are expected in 2021, and CRUK says that if the technology can accurately identify cancer the team it could in future be used routinely in GP practices to determine whether to refer patients for further diagnostic tests. If it can improve detection, treatment could be implemented earlier in the course of the disease when it is more likely to be successful.

The medical charity has earmarked £20m in funding for early detection research, recognising that almost half of all cancers were diagnosed at a late stage in England, according to 2016 figures.

The UK government also has early diagnosis in its sights, setting up a programme last year to explore the use of artificial intelligence (AI) in this setting with the aim of helping to prevent 22,000 deaths from cancer each year by 2033, and give patients an additional five years of healthy life by 2035.

Research has also found that the UK lags behind the rest of Europe for five-year survival rates for many common cancers, and has the worst outcomes in the EU for lung cancer.

“We urgently need to develop new tools, like this breath test, which could help to detect and diagnose cancer earlier, giving patients the best chance of surviving their disease,” says Prof Rebecca Fitzgerald, lead trial investigator at CRUK’s Cambridge centre.

Professor Rebecca Fitzgerald, lead trial investigator

“Owlstone Medical’s Breath Biopsy technology is the first to test across multiple cancer types, potentially paving the way for a universal breath test.”

Last month, genomics company Grail started a clinical trial of its proposed solution to the cancer diagnosis problem – a blood test designed to detect generic material from tumours that it hopes could allow disease to be detected before symptoms present. It intends to test the approach in 50,000 people aged 50 to 77.