Background: Despite improvements in treatment strategies, breast cancer survival rates remain low in India due to a lack of awareness and late stage of presentation. If diagnosed and treated early, breast cancer survival rates improve. Screening mammography, the gold standard in cancer diagnosis, is not feasible in a resource-constrained setting. Niramai’s novel breast cancer screening technology, Thermalytix™, applies Artificial Intelligence (AI) over thermography, to give an automated interpretation of the breast thermal images. The portable Thermalytix test has been so far used to screen 60000 women in community settings across India and Kenya. This study is a recent evaluation of the test in rural setting.

Methods: Women who provided written consent and who underwent Thermalytix tests in community-based screening camps at primary health centers (PHCs) in Afzalpur Taluk of Gulbarga District, Karnataka, India between 01 August 2021 to 15 June 2022 were included in this study. Five thermal images in multiple views were analyzed using Niramai’s patented algorithm. Automated analysis of the thermal images produced a screening report and triaged the participants for follow-up. In case of abnormal thermal activity, Thermalytix triaged women as ‘red’ and were referred to the district hospital for follow-up with breast ultrasound and/or other investigations and and were recorded into the following three categories: Normal (BI-RADS 1), Abnormal - benign (BI-RADS 2/3) and Abnormal - malignant (BI-RADS 4/5). If no abnormal thermal patterns were detected by Thermalytix, women would be recommended routine screening.

Findings: The analysis included 3531 women were included in the analysis and the median age in the cohort was 42 years. Of them, 97 (2.74%) women were triaged ‘red’ by Thermalytix indicating a suspicion of breast abnormality. As on 15 June 2022, 29 (30%) out of 97 women underwent standard follow-up investigations of which two cases of carcinoma breast, one case of phyllodes, one case of tuberculosis mastitis and seven other benign cases were identified, indicating that Thermalytix has a positive predictive value of 35.71% (11/29) in detecting benign and malignant breast lesions. Furthermore, a Patient experience questionnaire was used to asses their experience. 98.71% women were being screened for breast cancer for the first time in their lives. 93.9% women said they were very satisfied with Thermalytix screening experience and remaining 6.1% said they were satisfied, thus aiding in strong acceptability and adoption of the test.

Interpretation: In resource-constrained settings such as India, where less than 2% of the women in the country have ever got screening for breast cancer, the portable, no-radiation Thermalytix test is an accessible breast cancer screening solution. Thermalytix’s patient-friendly features - privacy-aware, painless, comfortable, and radiation-free make it favorable for population screening in India, and thus, can increase the uptake of breast cancer screening. With the device’s capacity to fit into a backpack, it can make breast cancer screening accessible to even remote areas with limited resources. However, following up on women who were found to be Thermalytix positive still remains a challenge. Future studies will emsure that follow-up after abnormal breast screening is part of the approved clinical protocol.

Results of the screening program

Results of the screening program
Results of the screening program

3 malignancies and 8 benign lesions found in 29 Thermalytix RED patients

Citation Format: Geetha Manjunath, Lakshmi Krishnan, Gargi Deshpande, Purnima Madhivanan, Karl Francis Krupp. Analyzing the performance of Thermalytix, an AI-based breast cancer screening solution, in a community setting [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-04-03.