The ReCIVA Breath Sampler allows exhaled biomarkers or volatile organic compounds (VOCs) to be reliably collected in a completely non-invasive manner and stored in a Breath Biopsy Cartridge. It is hoped that these VOCs can then be used for diagnosis and monitoring of a number of different diseases, including cancer.
The ReCIVA Breath Sampler is the subject of five ongoing clinical trials, two of which are focused on lung cancer. The most established, the Lung Cancer Indicator Detection (LuCID) trial, began in 2015 and is centred on early detection.
Lung cancer is the most deadly cancer in men and the second most deadly cancer in women. Early-stage lung cancer is associated with few to no symptoms, meaning that most lung cancer patients are diagnosed with advanced-stage tumours and have poor survival rates.
The LuCID study aims to establish the potential of using the ReCIVA Breath Sampler device for early detection of lung cancer by measuring VOCs in patients who are clinically suspected of having the disease. Interim results are reportedly encouraging and if the LuCID trial is successful, an eventual goal of Owlstone Medical is to implement widespread screening for lung cancer using the ReCIVA Breath Sampler.
Future of non-invasive cancer screening could benefit from previous trials
While the technology involved in the LuCID study is new, the rationale behind it is well established. It has long been speculated that effective lung cancer screening methods could result in earlier detection and allow more patients to be cured.
Randomised clinical trials were conducted as early as the 1960s and 1970s that evaluated the ability of chest x-rays and/or sputum cytology to screen for lung cancer, although ultimately these trials failed to improve lung cancer patient mortality.
Following this, the National Lung Screening Trial (NLST) explored the use of low-dose helical computed tomography (CT) to screen for lung cancer. This multi-centre, randomised study enrolled over 50,000 high-risk patients across the US between 2002 and 2004. After a median follow-up of 6.5 years, the NLST made a pivotal breakthrough and found that low-dose CT decreased lung cancer mortality by 20%, compared to chest x-rays.
It should be noted, however, that low-dose CT is associated with concerns regarding overdiagnosis and this procedure identified a number of abnormalities, which required invasive follow-up tests but turned out not to be cancerous. Subsequent analysis of NLST data suggested that approximately 18.5% of lung cancers detected by low-dose CT are overdiagnosed.
More recently, the benefits of low-dose CT scans for lung cancer screening in high-risk patients were confirmed by the 10-year follow-up of the NELSON trial. This European-based study analysed a similar patient population to NLST, and found an even greater positive impact on patient mortality. Additionally, this study found that approximately half of all lung cancers diagnosed in the screening group were early-stage and that the benefits of screening were greater in women compared to men.
A promising future is looming
Altogether, while the ReCIVA Breath Sampler represents a new and exciting device, these ongoing clinical trials represent the first stage in a long process. If this technology proves capable of early cancer detection, long-term follow-up studies will still be required to determine its potential impact on patient survival and to alleviate concerns about negative side effects, such as overdiagnosis and the costs associated with unnecessary and invasive treatments.
Furthermore, the two largest trials that have demonstrated a benefit of screening for lung cancer patients, NLST and NELSON, were both targeted at a specific group of high-risk individuals, namely those with a history of smoking ages 55–74 years. It has not yet been determined whether populations with different risk profiles would experience a similar benefit from these screening protocols.