NIRAMAI breast cancer screening test, Thermalytix, is a computer aided diagnostic engine that is powered by Artificial Intelligence. The solution uses a high resolution thermal sensing device and a cloud hosted analytics solution for analysing the thermal images for reliable, early and accurate breast cancer screening.
Thermalytix cancer screening test has been used by more than 100,000 women in 150+ hospitals/diagnostic center as well as 5000+ screening camps in India. The product is commercially available in India, UAE, Kenya, Philippines, Sweden, Bulgaria and Turkey. Niramai Thermalytix test has obtained a CE Mark for all European countries and regulatory clearance in the above countries.
Niramai Quality Management Processes are certified to be compliant with ISO 13485 and MDSAP. We follow good clinical practices, comply with information security and data privacy policies, as per EU GDPR and US HIPAA requirements.
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 non-inferior to X-Ray Mammography in general, and 25% better sensitivity than mammography in women with dense breasts.
Some clinical studies and real world evaluations published in top peer reviewed journal publications are listed below.
- Study 1: BMJ Open Journal, https://pubmed.ncbi.nlm.nih.gov/34667011/
- Multicentric study to evaluate the effectiveness of Thermalytix as compared with standard screening modalities in subjects who show possible symptoms of suspected breast cancer. BMJ Open. 2021;11(10):e052098
- Study 2: ASCO JCO Journal: https://pubmed.ncbi.nlm.nih.gov/33001739/
- Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women’, Journal of Clinical Oncology Global Oncology (JCO GO) from American Society of Clinical Oncology (ASCO). Oct 2020;6:1472-1480
- Study 3: Frontiers in AI Journal, https://www.frontiersin.org/articles/10.3389/frai.2022.1050803/full
- A prospective evaluation of breast thermography enhanced by a novel machine learning technique for screening breast abnormalities in a general population of women presenting to a secondary care hospital. Frontiers in Artificial Intelligence. 2023 Jan 4;5:1050803
- Study 4: International Journal Of Community Medicine And Public Health https://www.ijcmph.com/index.php/ijcmph/article/view/10481
- Feasibility and outcomes of using a novel artificial intelligence enhanced breast thermography technique, Thermalytix, in screening for breast abnormalities at primary health centres at the community level in South India, International Journal Of Community Medicine And Public Health, Vol. 9 No. 12 (Dec 2022)
- Study 5: Lancet Oncology https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00419-3/fulltext
- Performance of artificial intelligence-based breast cancer screening in a community setting: a real-world evaluation study. The Lancet Oncology. 2022 Jul 1;23:S20
- Study 6: SABCS 2022 https://aacrjournals.org/cancerres/article/83/5_Supplement/P3-03-25/717325
- An Automated Risk Stratification System for Breast Cancer Screening using Thermalytix. Cancer Research. 2023 Mar 1;and San Antonio Breast Cancer Symposium Dec 2022:P3-03
You can access the full list of Peer-Reviewed Publications about Thermalytix here
The innovative methods used in our test have led to 32 Granted Patents, including 11 Granted US patents, 11 granted Indian patents, and rest granted in Europe, Japan, Singapore, China and Canada.
