The U.S. Food and Drug Administration has granted 510(k) clearance to a Low-Dose Computed Tomography (CT) Lung Cancer Screening Option for Qualified GE Systems manufactured by GE Medical Systems, LLC. The 510(k) clearance applies to 26 models of CT scanners and is the first FDA clearance for a CT system with a specific indication for lung cancer screening.
"Bringing low-dose CT screening to patients at a high risk for lung cancer will reduce death from the most deadly cancer worldwide," Ella Kazerooni, MD, MS, Chair of the American College of Radiology's Committee on Lung Cancer Screening, noted in a news release from GE. "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."
Approximately 221,200 new cases of lung and bronchus cancer are predicted to be diagnosed in the U.S. in 2015, and 158,040 individuals will die from the cancers, according to estimates from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program. The five-year survival rate is 54.8 percent for lung and bronchus cancers diagnosed at stage 1, versus 27.4 percent to 7.5 percent for lung and bronchus cancers diagnosed at a later stage-though currently the majority (approximately 57%) of new cases of lung cancer are diagnosed after the original tumor has metastasized, according to SEER data.
The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as-or substantially equivalent to-a legally marketed device that is not subject to a Premarket Approval. This clearance allows GE to actively promote and advertise its 26 qualified models of CT devices for this specific indication, FDA spokesperson Angela Stark said in an email.
All of GE's new 64-slice and greater CT scanners, and most of GE's 16-slice CT scanners are qualified systems and will include this newly cleared screening option, according to the GE news release. The software that GE Healthcare developed can also be used in thousands of qualified GE scanners currently in use, according to GE.
Safety and Efficacy
The safety and efficacy of the screening test were established in the National Lung Screening Trial, which included more than 53,000 older patients who were generally healthy other than being considered at high risk for developing lung cancer due to their smoking history (OT 11/10/10 issue). Half the patients were screened using low-dose CT; the other half were screened using chest x-ray. The data found the mortality rate from lung cancer to be 20 percent lower in the group who had undergone low-dose CT screening compared with the group who had chest x-rays. The trial also showed a 6.7 percent reduction in the rate of death from any cause among the group who had t CT screening.
Current Recommendations
Low-dose CT lung cancer screening is recommended for adults who are at high-risk for developing lung cancer by the U.S. Preventative Services Task Force (for those who are 55 to 80) and the Centers for Medicare and Medicaid Services (for those who are 55 to 77). And Medicare has approved insurance reimbursement for its beneficiaries who are eligible if they are high risk.