Development and validation of artificial intelligence-based analysis software to support screening system of cervical intraepithelial neoplasia

Abstract Cervical cancer, the fourth most common cancer among women worldwide, often proves fatal and stems from precursor lesions caused by high-risk human papillomavirus (HR-HPV) infection. Accurate and early diagnosis is crucial for effective treatment. Current screening methods, such as the Pap test, liquid-based cytology (LBC), visual inspection with acetic acid (VIA), and HPV DNA testing, have limitations, requiring confirmation through colposcopy. This study introduces CerviCARE® AI, an artificial intelligence (AI) analysis software, to address colposcopy challenges. It automatically analyzes Tele-cervicography images, distinguishing between low-grade and high-grade lesions. In a multicenter retrospective study, CerviCARE® AI achieved a remarkable sensitivity of 98% for high-risk groups (P2, P3, HSIL or higher, CIN2 or higher) and a specificity of 95.5%. These findings underscore CerviCARE® AI's potential as a valuable diagnostic tool for highly accurate identification of cervical precancerous lesions. Its integration into clinical practice could enhance early detection and reduce screening disparities, especially in regions with limited access to skilled colposcopists. While further prospective research is needed to validate its clinical utility, this AI system holds promise for improving cervical cancer screening and lessening the burden of this deadly disease.