Preliminary experimental results from multi-center clinical trials for detection of cervical precancerous lesions using the Cerviscan™ system: a novel full-field evoked tissue fluorescence based imaging instrument

Cervical cancer is an important cause of death in women worldwide, accounting for 190,000 deaths annually. Women are currently screened for cervical cancer using Pap smear-an imperfect technology with poor sensitivity and specificity. Furthermore, 5-10% of the Pap smear studies result in uncertain findings called ASCUS. These patients are subjected to repeat Pap smears to determine women who need further examination by colposcopy. LifeSpex, Inc. is developing the Cerviscan™ system-a novel, full-field multi-spectral tissue fluorescence imaging system that is designed to detect cervical precancerous lesions (i.e. SIL) in real-time. We report preliminary results from a multi-center trial for evaluating the performance of Cerviscan™ system. A study population of 67 subjects, in three clinical sites in the US and Canada, each underwent three procedures, i.e. (a) repeat liquid-based Pap smear, (b) Cerviscan™ exam, and (c) colposcopy directed biopsy exam (gold standard). Fifty-two patients for whom data from all three exams were available (i.e. 78% of the patients enrolled) are included in this preliminary analysis; a multivariate classification algorithm has been trained using data from 228 regions (82 SIL, 146 NonSIL) in 42 women. Results are reported on an independent test set of 70 regions (25 SIL, 45 NonSIL) in 10 women. The Cerviscan™ system correctly identified 21/25 SIL and 42/45 NonSIL regions, giving a sensitivity of 84% and specificity of 93.3%. The Cerviscan™ system correctly resolved 5/7 ´ASCUS+LoSIL´ calls made by repeat liquid-based cytology. Furthermore, the Cerviscan™ system detected 2 patients with precancerous lesions that had been missed by the repeat liquid-based cytology. The Cerviscan™ system detects precancerous lesions with higher accuracy than repeat liquid-based Pap smear and locates lesion in real-time. The Cerviscan™ system has the potential of providing a tool that permits better patient management.