On February 13, 2014, BRASTER S.A. premiered a demonstration of its innovative TESTER prototype used for early detection and diagnostics of breast cancer in women. The device was developed based on the contact liquid crystal thermography by a group of Polish researchers from BRASTER S.A. listed with the NewConnect. According to the THERMACRAC Clinical Trial Report, the TESTER can be an important accessory in screening a broad range of patients for breast cancer, irrespective of age, tissue structure or temperature.
The TESTER is the world’s first device using liquid crystal thermographic matrices for breast cancer diagnostics. The device is totally safe and uses no harmful radiation. It is also non-invasive and completely painless to the patient.
“BRASTER S.A. has developed a fully professional and user-friendly device for diagnosing breast cancer in women. At the present development phase the device can be considered as complete in terms of its design and the Company has engineering capability to invest in the launch of manufacturing of the device.” said Krzysztof Pawelczyk, BRASTER S.A.’s President.
The ThermaCRAC Clinical Trial Report has confirmed efficiency of the technology underlying the TESTER. The trial led by Mr. Paweł Basta, MD with the Medical College of the Jagellonian University, was completed on a group of 736 patients with diagnosed breast cancer.
The direct aim of the trial was to compare the efficiency of the TESTER in diagnosing and differentiating breast pathologies in women vs. the conventional diagnosing methods. The trial has demonstrated that the sensitivity and specificity of the thermographic test was high compared to the standard diagnostic procedure: respectively, 72% and 58% better for the whole population, which was confirmed explicitly by the results of 3 independent interpretations. What is more, sensitivity of the multimodal procedure, combining thermographic and mammographic tests, compared to the whole diagnostic procedure was as much as 96%, which clearly shows the significant improvement in the efficiency of breast cancer detection when the both methods are used side by side. Given the total non-invasiveness and safety of the method, the results indicate that the liquid crystal contact thermography technology has good prospects in the further work on early breast cancer diagnostics.
Key conclusions from the Clinical Trial:
The sensitivity* and specificity** results of the trial imply that the TESTER will be efficient and useful in diagnosing breast gland pathologies.
The combination of the two diagnostic methods, thermography and mammography, was noted for improved breast cancer detection efficiency.
The three testing methods (thermography, mammography and ultrasonography) were found as potentially complementary due to their different detecting capabilities.
The TESTER can be considered a device helpful in diagnosing women’s’ breast pathologies including cancer.
“The ThermaCRAC Clinical Trial’s sensitivity and specificity results support a claim that the TESTER can be efficient and helpful in diagnosing breast gland pathologies. We have also noted an improvement in the efficiency of breast cancer detection when the two methods, thermography and mammography, were combined and, in addition, high sensitivity and specificity of the TESTER compared to the use of mammography alone in younger patients with adenoidal breast structure. The device can become a significant part of diagnosing young women who are now noted for increased incidence of malignant breast cancer” explains Paweł Basta, MD with the Medical College of the Jagellonian University, the researcher coordinating the ThermaCRAC Clinical Trial.
“According to the results and recommendations of the ThermaCRAC trial, we are planning for further development of the TESTER’s functionality. We are working to cut on the test time, improve its accuracy even more and make the device more ergonomic.” said Krzysztof Pawelczyk, BRASTER S.A.'s President.
Tumor diseases are one of the paramount health problems faced by women in highly developed countries. Breast cancer is one of the most frequent malignant tumors in women, representing approx. 25.2% of all diagnosed cancer cases. In 2012, more than 1.7 million breast cancer cases were diagnosed worldwide and the global GLOBOCAN research prognoses continued growth of the incidence by the end of this decade. The largest morbidity rates in Europe are found in Germany (71,600), France (54,200) and UK (52,400). The number of new cases diagnosed in Poland in 2012 was 16,500.
More than 5,000 Polish women die from malignant breast cancers every year.
Probability of seeing a positive diagnostic test result among sick patients. Higher sensitivity means that less positive cases go unnoticed.
Probability of obtaining a negative diagnostic test result among patients free from the disease being diagnosed for. Higher specificity means less false positive results (healthy persons are not reported as sick).