First Low-Dose Computed Tomography Lung Cancer Screening Test Cleared by US FDA

Early detection of lung cancer using low radiation-dose Computed Tomography (CT) screening is effective in reducing mortality rates in high-risk patients that have a history of smoking.

Lung cancer is the leading cause of cancer-related mortality in the US. To address this, the US National Lung Screening Trial (NLST) conducted a trial to screen more than 53,000 healthy patients who had a history of smoking, using low-dose CT or standard chest X-Ray imaging, at 33 medical institutions in the US. The results showed that low dose CT screening reduced the mortality rate from lung cancer by 20% compared to standard chest X-Ray screening.

The GE Healthcare (Chalfont St Giles, Buckinghamshire, UK) low-dose CT lung cancer screening system is the first CT device system to be cleared by the US Food and Drug Administration (FDA; Silver Spring, MD USA) for any screening indication. The program is effective in enabling earlier diagnosis, and treatment, and could save the lives of patients of patients at high-risk of lung cancer.

Dr. Ella Kazerooni, chair of the lung cancer screening committee at the American College of Radiology, said, “Bringing low dose CT screening to patients at a high risk for lung cancer will reduce death from the most deadly cancer worldwide. Performing low dose CT with attention to high image quality at the lowest radiation exposure to detect early cancer is at the core of a successful screening program, and requires collaboration with imaging partners to bring technology to bear for this purpose. The FDA’s clearance of these CT scanners for this purpose illustrates that commitment.”

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