Thermalytix: AI-Powered Breast Cancer Screening Test

What is Thermalytix

Thermalytix is a Novel Artificial Intelligence based medical device for detecting early stage breast cancer. It is an affordable, portable, safe and accurate method of detecting breast abnormalities. It is radiation free, employs no touch and no see approach and works for women of all age groups and breast densities.

Clinical studies show Thermalytix achieving high sensitivity and specificity rates that are non-inferior to current screening methods. The sensitivity has been found to be better than conventional 2D mammography in younger women and dense breasts.

Thermalytix is a screening test highly suitable for large-scale public health programs and corporate wellness initiatives. It can also be used as a part of the preventive wellness services in hospitals and diagnostic centers. Women found to be high risk or positive in Thermalytix will be referred for detailed diagnostic imaging (Mammography, Ultrasound or MRI) by the expert radiologist.

In Low and Middle Income Countries, we see high mortality rates due to low screening uptake. Average screening uptake in LMIC countries is a mere 2.2%, with India showing just 1.3%. Our aim at Niramai is to enable Thermalytix as an affordable, accessible and accurate screening method so that more women will detect their abnormalities early and save treatment cost as well as live longer.

How does it work

The solution uses a high resolution thermal sensing device and a cloud hosted analytics solution for analyzing the thermal scans to automatically generate an accurate breast cancer screening report. This report can be reviewed by an expert to determine the care management pathway.  Thermalytix includes innovative machine learning and deep learning algorithms to analyze 400,000 temperature points on the chest to automatically generate a quantitative report showing a breast health score and assist doctors in identifying abnormal breast lesion.  

Thermalytix AI algorithms detect subtle temperature abnormalities (such as abnormal blood vessel patterns and unusual heat signatures) that human interpretation might miss. The AI analyzes 400 thousands of temperature points per image, providing a consistent, quantitative risk score. It hence reduces subjectivity and human error that comes with manual interpretation of thermal images.

Thermalytix AI algorithms are trained on large datasets of thermal images along with the corresponding reports of radiological imaging (Mammography and Ultrasound) and histopathology (for positive patients). Hence the AI engine is able to recognize complex patterns linked to malignancy, and also reduce the number of false positives. The AI algorithms learns to adapt over time, improving with more data and diverse patient populations from different geographies.

For more details of the technical workings, please see our publications page.

Thermalytix is not Thermography

Niramai’s Thermalytix offers significant advantages over conventional thermography through its integration of artificial intelligence and enhanced thermal sensitivity. Thermography is manual interpretation of thermal images. Thermalytix reporting is Computer-Aided Artificial-Intelligence based and these reports are reviewed by an expert radiologist also trained in thermal interpretation.

Thermalytix does not analyze thermal images, it uses temperature maps on the chest for the analysis. This provides 50x greater thermal sensitivity to Thermalytix (0.02°C in temperature maps vs 1°C in a thermal image) which enables detection of abnormal patterns before they become visible in imaging resulting in earlier detection of abnormalities and better clinical outcomes.

For a detailed information of how Thermalytix is different from Thermography, please refer to this document.

Global Reach and Quality Assurance

Thermalytix is commercially available in 22 countries, including India, Philippines, Zambia, Sweden, Bulgaria and UK. Thermalytix has obtained a CE Mark for all European countries and regulatory clearance in many African and Asian countries.  We also have another device with subset of Thermalytix functionality called SMILE-100 or BreastHealth-100 which has US FDA clearance for adjunctive use.

Niramai Quality Management Processes are certified to be compliant with ISO 13485 and MDSAP.  We follow good information security and data privacy policies, as per ISO 27001, EU GDPR and US HIPAA requirements. Please click on the icons to access the regulatory certificates.

Intellectual Property

The innovative methods used in our test have led to 39 granted patents – which includes 15 Granted US Patents. 14 Indian Patents and 2 patents each granted in Canada, Singapore, Japan, Europe and China.