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First Warning Systems, Inc. is licensed by its parent company, Lifeline Biotechnologies. The license grants First Warning Systems, Inc. all rights, worldwide, for further product development, regulatory, manufacturing and marketing.
First Warning System™(FWS) is a novel breast health screening device and method based on disruptive technology and tissue health science. 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. Independent market research with physicians, patients and managed care executives has also been completed indicating this is a potentially attractive system that addresses unmet need in the field of breast cancer detection and diagnosis by identifying breast tissue abnormalities more reliably and much earlier than other diagnostic modalities.