FAQ
Are there are clinical publications showing the accuracy of Thermalytix?
Yes, Thermalytix has been clinically proven for high sensitivity and good specificity. There are 42 peer reviewed publications in top journals and conferences. 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/ o 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/ o 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:FrontiersinAIJournal, https://www.frontiersin.org/articles/10.3389/frai.2022.1050803/full o 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 o 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) Study5: LancetOncology https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00419- 3/fulltext o Performance of artificial intelligence-based breast cancer screening in a community setting: a real-world evaluationstudy. The Lancet Oncology. 2022 Jul 1;23:S20 Study 6: SABCS 2022 https://aacrjournals.org/cancerres/article/83/5_Supplement/P3-03-25/717325 o 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.
Can you tell me about the screening test experience ?
Niramai Thermalytix screening is a very privacy aware test where no-one sees you or touches you during the test. Please watch the following videos for an introduction to the screening test. Patient experience video Guidelines for Breast Health Screening.
What is the novelty in NIRAMAI solution?
NIRAMAI is the pioneer of a patented technology called Thermalytix© which is a novel fusion of Artificial Intelligence and Breast Thermal Scans. NIRAMAI early stage breast cancer screening solution is a non-contact, non-invasive, portable, safe, automated solution that works for women of all ages. The novel AI and ML algorithms for the analysis of thermal images have resulted in Eleven granted US patents and many more patent applications.
Is NIRAMAI Theramalytix different from Thermography?
Yes, Thermalytix is different from Thermography. Thermography is visual analysis of thermal images, while Thermalytix uses sophisticated computer aided analysis using artificial intelligence for accurate analysis of thermal maps. Thermography is an old technique that has been in practise by some medical professionals around the world for analyzing thermal images. It is recommended as an adjunct modality to detect early stage breast cancer. However, manual analysis of thermal images requires highly trained skilled professionals, and many times results in a number of false positives. NIRAMAI’s Thermalytix solution fixes this accuracy issue using machine intelligence and provides an , automated method of quantfying thermal scans, and enabling screening for early stage breast cancer and other breast abnormalities. NIRAMAI Thermalytix has much higher accuracy than Thermography. There are some important considerations showing why the Niramai solution is not the same as Thermography, and those differences are detailed below: 1. NIRAMAI Thermalytix© is different from Thermography. Though the sensing equipment used by Thermalytix is Infrared/Thermal Camera, similar to the one used by Thermographers, Thermalytix is based on analysis of temperature maps, where are thermography analyzes thermal images. 2. NIRAMAI Thermalytix Solution uses a unique AI-enabled software that gives objective assessment of the thermal analysis, which is missing in thermography. Additionally, demography data about the patient as well as a novel vascularity analysis is performed. So, we should treat Thermalytix as a new solution for detecting breast abnormalities. 3. Thermography clinics provide a report based on visual analysis of thermal images. Thermal images are very complex with about 400,000 temperature points shown as a color pixels, where each pixel can be any of the 2000 colors. Analyzing and interpreting these thermal images with just visual inspection is a huge cognitive overload for even an experienced thermographer. So, the manual diagnosis used in Thermography is error prone and hence the FDA guidance of using thermography as an adjunct to existing methodologies. However, NIRAMAI Thermalytix is not Thermography. 4. Thermography clinics are also NOT able to provide any report with one sitting of the patient. They usually ask the patient to come back in 3 months and do a visual inspection of 2 different sets of images taken 3 months apart. This results in potentially missing a case that was evident in the first sitting, and delaying the identification of malignancy for the patient. NIRAMAI solution is able to analyse the thermal images for every screening instance and provide a quantitative report. 5. NIRAMAI solution is based on machine learning models – that have the ability to analyse all the 400,000 color points both in imaging domain as well as temperature domain. A difference of 0.02 deg C is perceived by NIRAMAI software and hence the analysis is very sensitive, unlike thermography where two different shades of a color are hard to distinguish. 6. NIRAMAI machine learning models are calibrated with historical data labelled with current standard of care. The way NIRAMAI models were trained was based on labels learnt from mammography + sono-mammography + biopsy. It was not trained using reports of thermographers, hence NIRAMAI results are more accurate and better than current standard of care. 7. Niramai Thermalytix additionally uses patented vascular biomarkers which is able to detect very deep tumours, which are generally missed by thermographers, as there may not be an increase in temperature for the same. 8. In order to make an objective comparison between Thermography and Thermalytix, a clinical trial on 303 patients was conducted in a blinded retrospective analysis. This was peer-reviewed and published in International Conference on Advances in Breast Cancer Treatments, Kyoto, Japan, April 26-27, 2018. The results of this comparison showed a remarkable improvement in performance of Thermalytix over Thermography. An increase of 70% was seen in Positive Predictive Value over Thermography was seen, with very high levels of sensitivity and specificity. A copy of the paper that compares results of Thermography and NIRAMAI Thermalytix is available here Thermalytix has regulatory clearance in India, Europe, UAE and Kenya at this time and usage in these countries does not fall under the purview of the above mentioned US FDA warning communication. While Niramai has not yet applied for US FDA clearance for Thermalytix, Niramai obtained US FDA clearance for our SMILE-100 tool that has subset of features of Thermalytix.
What exactly is done in NIRAMAI breast screening?
Niramai solution is based on Thermography. Niramai thermal device which is placed 3 feet in front of the patient captures 5 thermal images of the region. Niramai software tool automatically analyses these images and sends the analysis report that is certified by a Senior Radiologist. For more details, please watch this video https://youtu.be/RT5njRmAdZk What is the ideal time in a month to go for NIRAMAI/Thermography screening. Ideal time period for a woman is from ovulation to the onset of menstruation. I am interested in going through NIRAMAI Breast Screening.Where should I come? Please click on the link “Register for Screening” and share your details or just drop a note on the contact form with your location and contact details. Our customer support will reach out to you for an appointment in the nearest centre. Alternatively, you can find a center on Google Map with search keyword “Niramai Breast Clinic near me”. Many of our centers are listed there. Niramai test is available in 150+ locations in India, Kenya, Philippines, Sweden, Bulgaria, Turkey and UAE.
What is the minimum age for thermographic/NIRAMAI screening
There is no minimum age for thermographic screening. It doesn’t depend on the age, color, race and density of breast. Any girl post menstruation should be conscious of her breast health.
Is Thermalytix painful like Mammography
No. Thermal scanning is a are non-contact, non-invasive and radiation free modality, unlike mammography. Thermal scanners just measures temperature on your skin, there is no harmful radiation exposure too.
Is there a regulatory approval for Thermalytix breast health screening
Yes. NIRAMAI Thermalytix has received regulatory approval from India, Kenya, UAE, Philippines and all countries in Europe (CE Mark). SMILE-100 (with subset of features of Thermalytix) is regulatory cleared by US FDA. All Thermal devices used along with Thermalytix software are also US FDA cleared and have European CE Mark. I am interested in buying NIRAMAI Solution. Whom should I contact? If you are hospital or diagnostic centre interested in deploying this solution in your centre, please drop a note to contact@niramai.com. We will arrange a free demonstration of the solution and discussion with Niramai BD team. Niramai test is now deployed in 150+reputed hospitals and diagnostic centers such as Apollo Clinics, HCG, Narayana Health and more. If you are a corporate interested in your employee wellness or an NGO interested in conducting screening camps for women, Niramai solution is available on monthly or daily-rental basis too. Please drop us a note on contact@niramai.com . For deeper collaboration with Niramai, please write to partnerships@niramai.com My relative has/had breast cancer. What is the risk of me getting breast cancer It depends on how close you are with the relative. If the relative is a first degree relative (Parent, Sibling or Child) you have a more risk of cancer and is recommended to go for frequent screening. If the relative is a second degree relative, the risk is less compared to former.
How frequent do I need to have the screening
Early detection is very important to have a good cure. We recommend Thermalytix scan once a year for all females above 25 years. Since Thermalytix give breast health scores, if your score is all zero, you can repeat it once in 2 years, instead. Things patient should do for perfect thermography/NIRAMAI screening before examination Patients suffering from fever can postpone their screening to a future date, just to avoide inconvenience to them. Alcoholic beverages should not be consumed for twelve hours prior to the test. Hot tea or coffee should be avoided for at least one full hour before examination. Aspirins, pain medications, vasodilators, constrictors should be avoided for 24 hours prior to test.
When should I start going to breast cancer screening?
While the global guidance advices women above 45 years to take a breast cancer screening test every year, statistics from World Health Organization (WHO) shows that the incidence rates for women below 40 years is also increasing. About 28% of breast cancer deaths are under 45 year. This would worsen in future due to stress, changes in lifestyle and increase in pollution. So, we recommend all women above 25 years to undergo breast screening using radiation-free Thermalytix test at least once. Based on the scoring, we give personalized recommendation on when you need to repeat the test.
