Cervical cancer ranks as the number one form of cancer in India among women belonging to the socio-economically disadvantaged rural population and is the leading cause of cancer death for women in developing countries. As against the prevailing techniques such as Pap smear and coloposcopy (with VIA and VILI), optical technologies can improve the accuracy and speed of cervical cancer screening as these can detect changes in tissue architecture, cell morphology and biochemical composition. Towards this Sascan has developed a hand-held non-invasive device for cervical cancer screening and early detection of cervical cancer by capturing fluorescence and diffuse reflectance images in vivo through an inserted speculum. With the help of proprietary software and multimodal imaging technology the clinician is able to examine the cervix and assess the grade of cervical intraepithelial neoplasia (CIN) with the help of a machine learning (ML) algorithm on illumination with LED light sources centred at the peaks of collagen and oxygenated haemoglobin (HbO2) absorption.
The processed images are pseudo colour mapped to locate the most malignant site on the cervix for biopsy and pathological confirmation of the CIN with improved accuracy, thereby minimizing under diagnosis and patient trauma. We believe that even Pap smear tests can be made more effective and accurate as the device will be able to guide the clinician to which segment of the cervix to focus while taking a smear for cytology.
The phase I trial of the first prototype was conducted in 109 patients in Kasturba Medical College, Manipal. A sensitivity of 100% and specificity of 93% was obtained in discriminating normal from abnormal (precancer and cancer) patients.
The pivotal trial of the device is ongoing in SAT Hospital for women and children, Govt medical college Thiruvananthapuram.
After completing the multi-centric trials, the device will be available in the market soon.