The system is a non-invasive breast physiology screening system, much more sensitive and much more cost effective than mammography. The platform has applications for both OB/GYN and primary care in-office use, as well as potential use as an over-the-counter (OTC) diagnostic system. Three preliminary clinical studies in more than 650 women have been completed yielding compelling results, demonstrating an average accuracy of 92.1% (percentage of correct classification), an average sensitivity of 94.7% (true positive cases), and an average specificity of 91.1% (true negative cases). In comparison, the specificity and sensitivity of the gold standard mammogram averages 70% and the accuracy of interpretation is completely subject to the skill and ability of the reading radiologist.
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