Clinical and Regulatory

NIRAMAI Thermalytix has been validated in systematic clinical studies in reputed hospitals. 

Our cancer screening tool has been tested on more than 65000 women in 100+ hospitals/diagnostic center as well as 5000+ screening camps. Results of multiple clinical studies comparing Thermalytix with current standard of care have been published in peer  reviewed conference/journals. The results from these clinical trials indicate very high accuracy of Thermalytix that is comparable and sometimes better that Mammography.

Thermalytix is also regulatory cleared in India. Kenya, UAE and has obtained a CE Mark for European countries. Recently Niramai SMILE-100 which has subset of features of Thermalytix got US FDA clearance. Our Quality Management Processes are certified to be compliant with ISO 13485, MDSAP and GDPR. We follow good clinical practices, comply with information security and privacy policies.

Below are the highlights of the results from clinical studies performed using Thermalytix :
  • Over 90% sensitivity in all trials
  • 27% higher sensitivity than Mammography (most of the additional cancers detected were in dense breasts)
  • 70%  higher positive predictive value than Visual interpretation of Thermography (results from traditional thermography are very subjective and error prone)
  • Thermalytix is effective in 32% more patients walking into a hospital with pain or discomfort in their breasts (as it works for younger women/dense breast women)
  • Was able to detect cancer lesions as small as 4 mm with no palpable lumps.

Summary of one Study: In a multisite study conducted in India, 470 women underwent Thermalytix™ test and one or more standard-of-care tests for breast cancer screening as recommended by the radiologists. Thermalytix™ demonstrated an overall sensitivity of 91.02% (95% CI, 81.8% to 96%), a specificity of 82.39% (95% CI, 78.2% to 86%) and a NPV of 97.88% in detection of breast malignancy. The sensitivity and specificity in asymptomatic screening population was 100% and 92.41%, respectively. In symptomatic women, the sensitivity was 89.85% and specificity was 69.04%. Ground truth for this analysis was derived from a combination of mammography, sono-mammography and biopsy results. Compared to our technique, mammography could be performed only on 242 women due to dense breasts and other limitations. In this subset of 242 women, Thermalytix™ showed higher sensitivity of 91.23% compared with mammography’s sensitivity of 85.96%.

Reference: Observational study to evaluate the clinical efficacy of Thermalytix™ for detecting breast cancer in symptomatic and asymptomatic women as compared to standard imaging modalities, ASCO JCO Global Oncology, Oct 2020.

Other clinical studies have also demonstrated high Sensitivity, Negative Predictive Value and Specificity of Thermalytix™ in women of all age groups, in women with dense breasts (ACR categories ‘c’ and ‘d’), ability to detect lesions as small as 4 mm and non-inferiority in sensitivity and specificity with screening mammography.

List of Peer-Reviewed Publications in Medical and AI journals