Cerviscan

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 PpIX and oxy/deoxy-genated haemoglobin (HbO2) absorption.

The processed images are analyzed and 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. The DR ratio image will be superimposed on the Hammonds clock diagram to locate the exact site of biopsy thereby avoiding unwanted multiple biopsies and attaining high diagnostic accuracy.

The pilot studies with the first prototype of CerviScan were conducted in 109 patients at the Kasturba Medical College, Manipal. A sensitivity of 100% and specificity of 93% was obtained in discriminating normal from abnormal (precancer and cancer) cervix in the studied population. The study results are published in the Artificial Intelligence in Health journal (Phebe et al, 2025).

The Phase-1 trial was conducted in 500 women at the SAT Hospital, Govt Medical College, Thiruvananthapuram.  A multi-centric trial covering 5 institutions under the Indian Council for Medical Research (ICMR), Govt of India, is initiated as part of the Medtech Mitra scheme, to develop an algorithm and to validate the device.

After completing the multi-centric trials, and the CDSCO approval, the device will be introduced into the market.