Clinical Trial to Assess a Pioneering Breath Test for Lung Cancer Diagnosis

Clinical Trial to Assess a Pioneering Breath Test for Lung Cancer Diagnosis

lungsResearchers at the University of Leicester in England will conduct a clinical trial at the Glenfield Hospital in Leicester to assess the efficacy of a pioneering breath test device for lung cancer detection in early stages.

Lung cancer is one of the most common cancers and the primary cause of cancer-related deaths in the United States and worldwide for both men and women. Detection of this cancer in its earlier stages is critical for improved patient outcomes.

Cambridge-based Owlstone Nanotech Ltd developed a breath test device that allows a non-invasive lung cancer diagnosis in its early stages by detecting biomarkers indicative of the disease. The device was developed within the Lung Cancer Indicator Detection (LuCID) program, whose primary goal is to improve lung cancer screening methods for earlier treatment and management of the disease. The project expects to save 10,000 lives and about £250 million of National Health Service (NHS) funds by 2020 by improving the detection of early-stage lung cancer.

The NHS Small Business Research Initiative (SBRI) awarded Owlstone £1m to support the next stage of the LuCID project, the clinical trial studies. The device uses a small chemical sensor on a chip to analyze signature volatile organic compounds (VOCs) in a patient’s breath that are known to be associated with lung cancer. The sensor is defined as Gas Chromatography – Field Asymmetric Ion Mobility Spectrometry (GC-FAIMS). If approved, the device will offer a cheaper and easy-to-use alternatives compared to the existing detection methods.

The co-founder of Owlstone Billy Boyle said in a news release: “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 office. Our team will not rest until we help stop the daily devastation that cancer brings to patients and their families.”

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The clinical trial will be conducted by Dr. Salman Siddiqui from the University of Leicester and Glenfield Hospital, and the results are expected in early 2016.

“Lung cancer has one of the lowest 5-year survival rates of all cancers, however early diagnosis can greatly improve a patient’s prognosis. Current diagnostic procedures such as a chest X-ray, CT scan and bronchoscopy are costly and not without risks so the benefits of a non-invasive, cheaper alternative are clear,” explained Dr. Siddiqui. “This project will seek to identify and evaluate biomarkers in order to improve the accuracy and reliability of breath diagnostic methods. We will also be aiming to establish FAIMS as a faster, less expensive and more portable alternative to gas chromatography-mass spectrometry (GC-MS) for breath diagnosis applications.”

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