Onco-LIFE™ - Information for Healthcare Providers

The Onco-LIFE™ system consists of an endoscopic light source and video camera that attaches to a standard fiberoptic endoscope to illuminate and acquire real-time images of lung tissue during an endoscopic examination. Using Onco-LIFE™, physicians can easily switch between conventional white light (WL) and fluorescence (FL) modes with the simple push of a button.

The Onco-LIFE™ received FDA approval on June 30th, 2005 (P950042/S003). Onco-LIFE™ is indicated for use with fluorescence imaging during bronchoscopy as an adjunct to white light imaging, to detect and localize tissue suspicious for moderate or severe dysplasia, carcinoma in situ (CIS) or invasive cancer in patients with suspected, or previously treated lung cancer. In an international, multi-center clinical trial, white light + fluorescence endoscopy using Onco-LIFE™ for the detection of early lung cancer (moderate/sever dysplasia and CIS) demonstrated a 325% improvement in sensitivity on a per-lesion basis and a 250% improvement in sensitivity on a per-patient basis when compared to white light endoscopy alone. When the detection of invasive cancer was included in the analysis, white light + fluorescence endoscopy using Onco-LIFE™ demonstrated a 50% improvement in sensitivity on a per-lesion basis and a 33% improvement in sensitivity on a per-patient basis compared to white light endoscopy alone.

(Summary of Safety and Effectiveness, Onco-LIFE™ P950042/S003: www.fda.gov/cdrh/pdf/p950042s003.html)