RICHMOND, BC--The FDA's Ear, Nose, and Throat Device Advisory Panel has voted unanimously in favor of recommending a premarket approval (PMA) application for Xillix LIFE-Lung, a fluorescence imaging system that helps identify early lung cancer (see figure ).
Uses Blue Light
The recommendation is conditional on minor changes to the labeling and initiation of a postmarket surveillance study, said the manufacturer, Xillix Technologies Corp. The device was developed at the British Columbia Cancer Agency, Vancouver.
The Xillix LIFE (Lung Imaging Fluorescence Endoscope)-lung device uses blue rather than white light to take advantage of natural differences in fluorescence between normal and cancerous or precancerous tissues.
The natural fluorescence images are captured and intensified by the LIFE camera, and the information is digitized and displayed in real-time on a color monitor. The physician can then visually identify areas from which to collect biopsies.
The FDA panel has recommended that the device be approved for use in patients with known or suspected lung cancer to identify suspicious tissue. The device has been shown to improve the physician's ability to spot early lung cancer by 211% specifically in those patients suspected of lung cancer, the company said.
Results from a multicenter clinical trial indicated a 171% improvement in the physician's ability to identify and locate tissue suspicious for moderate to severe dysplasia or worse using Xillix LIFE-Lung as an adjunct to white light bronchoscopy, compared with conventional white light bronchoscopy alone.