Biop System's Safety and Performance

"Stage 1 - Training:~Up to 320 women in whom a complete procedure with the Biop System will be performed. Biopsies will be taken solely based on colposcopy examination. Enrolled participants will include at least 80 participants Histopathology identified with a high-grade lesion and at least 80 participants Histopathology identified as normal or with a low-grade lesion.~Stage 2 - Validation:~Up to 330 HIV negative women in whom a complete procedure with the Biop System will be performed.~Validation stage will also include up to 165 HIV positive participants. All participants will be enrolled in up to 3 sites in South Africa."