A Singapore company has developed a non-invasive breath analysis device and test to detect early stage lung cancer by collecting and analysing a patient's exhaled breath. According to The National Lung Screening Trial Research Team, 80% of lung cancer cases are diagnosed at late stage when the 5-year survival rate is only 5%. If detected at stage 1, the survival rate can be increased to 80%.
Current diagnostic techniques such as Computer Tomography (CT) are not able to capture most of the early stage cases because the tumour at this stage is too small to be distinguished. This non-invasive breath-based solution analyses the Volatile Organic Compounds (VOC) in a patient's exhaled breath to detect the changes in metabolic activities caused by lung cancer. In the pilot clinical trial, the breath analyser with machine learning algorithms was able to detect more early stage lung cancer cases than current diagnostic techniques.
The human breath contains thousands of VOCs that are produced by metabolic activities. As soon as cancer cells start to grow, metabolic changes occur, producing volatile cancer biomarkers that can be detected in the breath. In this technology, the unique breath prints of lung cancer have been successfully identified and algorithms to detect it in its early stages have also been developed.
Due to the extremely low levels of breath biomarkers (parts per billion or even parts per trillion) and how they can easily be affected by many confounding factors, the key to a successful breath test lies in the sampling procedure to obtain high-quality breath samples. The startup has developed a proprietary breath sampler that addresses all the confounding factors while being able to sample breath in a highly accurate and standardised way. This technology is uniquely capable of being the only one able to conduct a direct online (real time) breath analysis, eliminating sample degradation during storage and transportation, and thus ensuring higher accuracy.
In its proof-of-concept clinical trial, not only could this breath test differentiate lung cancer patients from control subjects, it also showed the potential of breath tests for early detection as the breath profile of early stage lung cancer was found to be significantly different from that of a control subject. In its pilot clinical trial, the technology successfully identified five early stage cases, and was able to capture more early stage cases than current diagnostic techniques. In in-vitro studies, the technology was further able to identify VOC profiles for the different subtypes of lung cancer, indicating how breath VOC tests have the potential to help doctors quickly identify the histological types of lung cancer without the need for biopsies.
The lung cancer detection solution has the potential to change the way lung cancer is being diagnosed in hospitals and increase early detection rates as current diagnostic techniques such as CT are not capable of capturing early stage cases. Not only will this technology be able to significantly increase the opportunities for early detection and therefore better prognosis, there are also indications of how this method of testing has the potential to help doctors to quickly identify the histological types of lung cancer without the need for biopsies.
The global lung cancer diagnostic market was $1.6 billion USD in 2015 and it is projected to reach $3.6 billion USD in 2024 with a CAGR rate of more than 9.5%. North America was identified as the largest regional market and the Asia Pacific region as the fastest growing market segment, expected to reach a revenue share of over 28% by 2024. Major factors responsible for this growth include the constantly improving healthcare infrastructure, the growing awareness of the disease symptoms and a wide base of unmet clinical needs in the developing countries in the region.
The problem with lung cancer is late diagnosis as lung cancer is usually asymptomatic in its early stages. Symptoms such as weakness, breathlessness or coughing are viewed by patients as signs of aging. By the time they are diagnosed, 80% of the patients are at the late stages of the disease with poor prognosis. The 5-year survival rate of stage 4 lung cancer patient is only 5%; however, if detected at stage 1, the survival rate increase to 80%.
The burden of lung cancer to the healthcare system is the highest among all cancer types. The estimated cost of lung cancer to the UK NHS is ₤9071 per patient per year and the total cost of lung cancer to the UK economy is ₤2.4B, more than any other cancer.