CAMBRIDGE, U.K.—Diagnostics company Owlstone Medical is embarking on the world’s largest clinical trial for a breath test to detect lung cancer. The Lung Cancer Indicator Detection (LuCID) test is said to be quick, easy to use and non-invasive. Most importantly, though, it reportedly has the capacity to identify lung cancer markers when the disease is at stage 1, thereby potentially saving some 10,000 lives by 2020, according to the hopes and plans of the National Health Service initiative in the United Kingdom that originally funded the work.
“Early detection through improved screening is the greatest opportunity for improving patient outcomes. Owlstone Medical was created specifically to advance our breathalyzer for very early stage diagnosis of disease, to enable more effective treatment and better patient outcomes,” says Billy Boyle, Owlstone Medical’s co-founder and CEO.
Patients with lung cancer have volatile chemicals in their breath that indicate the presence of the disease, even at very early stages. The LuCID test collects these chemicals by having the patient breathe normally into the Respiration Collector for In-Vitro Analysis (ReCIVA) breath sampler. They then analyze these chemicals to differentiate between healthy patients and those with lung cancer using a field asymmetric ion mobility spectrometer (FAIMS) detection platform. Through this method, the test can accurately and selectively detect lung cancer volatile organic compounds (VOCs) in breath.
“The need to explore novel approaches for the early detection in lung cancer has never been greater. I am particularly excited about the opportunity that the Owlstone LuCID project brings to study the role of VOCs for the early detection of lung cancer. If VOCs work, then it may be possible to use a simple breath test to help identify whether someone has lung cancer or not,” commented the leader of the study, Dr. Robert Rintoul, the lead clinician for thoracic oncology and director of the clinical trials unit at Papworth Hospital in Cambridge, U.K.
This largest-ever clinical trial of its type has already recruited more than 3,000 patients from more than 20 sites in the United Kingdom and the rest of Europe. The aim of such a large group is to ensure that the test is sufficiently powered both for early cancer detection, and also for differentiation between benign nodules and malignant tumors. The final phase of the study will involve blinded external validation to provide “unequivocal” results regarding the accuracy of the test. The main study is slated for completion in 2017, before being released to market.
The LuCID test offers other benefits to existing diagnostic capacity. Because it is non-invasive, it eliminates the need for animal trials as the exhaled biomarkers of animals very likely differ from humans. In addition, existing diagnostics include computerized tomography and positron emission tomography screening tests that result in high numbers of false-positive results, and complications arising from invasive biopsy follow-up testing. Using the LuCID test to avoid these procedures will save patients pain and worry and will save healthcare providers money.
Interim results from the test are promising, both in terms of potential accuracy and patient compliance, with 97 percent of test patients reporting the ReCIVA to be comfortable and easy to use.
Owlstone is eager to get the test to market, with a stated goal of savings tens of thousands of lives by detecting lung cancer early when it is more treatable. If detected at stage 1, the five-year survival rate for lung cancer is 54 percent, but this drops to just 4 percent if the cancer is detected at stage 4.
According to the World Health Organization, lung cancer is the most common cancer in the world with an estimated 1.8 million cases and 1.6 million deaths in 2012. It is estimated that in 2016 there will be over 221,000 new cases of lung cancer in the United States and at over 158,000 deaths, it is the number one cause of cancer deaths.