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FDA clears low-dose CT lung cancer screening option
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GE Healthcare today announced the FDA has issued clearance for the company’s low-dose CT lung cancer screening option for qualified GE Systems.
GE Healthcare is the first company to receive FDA clearance for a lung cancer screening option. The option includes new low-dose screening reference protocols personalized to the CT system and patient size based on the most up-to-date recommendations from professional medical and governmental organizations. All of GE Healthcare’s 64-slice and greater CT scanners and a majority of their 16-slice CT scanners are qualified systems that will include the screening option.
The U.S. Preventive Services Task Force recommends low-dose CT lung cancer screening for individuals aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or who have quit within the past 15 years. Further, CMS has approved insurance reimbursement for Medicare beneficiaries aged 55 to 77 years who are eligible for low-dose CT lung cancer screening.
Low-dose CT lung cancer screening can increase early detection of lung cancer in high-risk individuals and substantially reduce the number of lung cancer-related deaths. Results from the National Lung Screening Trial demonstrated that low-dose CT screening in high-risk patients reduced mortality from lung cancer by 20% and mortality from all causes by 6.7% compared with chest X-ray.
Ella A. Kazerooni
“Bringing low-dose CT screening to patients at a high risk for lung cancer will reduce death from the most deadly cancer worldwide,” Ella A. Kazerooni, MD, chair of committee on lung cancer screening of the American College of Radiology and professor of radiology at University of Michigan Health System, said in a press release. “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.”