There have been nine clinical studies involving 1,155 symptomatic patients using SureTouch technology in the United States, China, and the United Kingdom. Meta-analysis of these studies using pathology as the gold standard was performed. The sensitivity of SureTouch to detect breast masses when used to identify the presence of an abnormality was 89%, in comparison with the CBE at 83%.
To identify the presence of breast cancer, the sensitivity of SureTouch in detecting breast cancer was 85%, in comparison to CBE (59%), mammography (76%) and ultrasound (90%) . The specificity of SureTouch in detecting breast cancer was 79%, in comparison to CBE (78%), mammography (71%) and ultrasound (79%). The accuracy of SureTouch in detecting breast cancer was 82%, in comparison with CBE (67%), mammography (74%) and ultrasound (84%). The following table summarizes this information.
Breast Cancer Detection Summary on Symptomatic Patients:
|Sensitivity for Cancer Detection||85||76||90|
|Specificity for Cancer Detection||79||71||79|
|Accuracy for Cancer Detection||82||74||84|
The following graph summarizes the specificity and sensitivity in identifying breast cancer from six of these studies all using pathology as gold standard: