Lifeline Biotechnologies, Inc announced that it has made its initial filing of its First Warning System with the Food and Drug Administration.
Jim Holmes, Lifeline’s CEO said that “through its consulting firm, Lifeline has submitted the First Warning System process and technology to the FDA. The purpose of this filing is to obtain the FDA’s opinion requesting a classification of this device. The opinion as to the classification is expected to determine the subsequent filing and registration required to clear the First Warning System for marketing in the United States. The FDA’s response is expected to take several months.”
Holmes went on to say, “this is a very exciting time for us and those that are interested in this innovative, leading edge, and disruptive technology. The First Warning System is a device and process which assists in the early detection of breast cancer, designed, developed and tested with approximately 700 women. This process has the potential of changing the way breast cancer is identified. After many years and many resources applied, we’ve moved to the important point of entering the process of clearance of this device with the FDA. The next step is expected to be obtaining clearance for market entry.”
Lifeline Biotechnologies previously received two patents on its First Warning System hardware and has in the past year filed for a patent on the technological advancements of the First Warning System software. The software has achieved the robust capability of identifying and classifying tissue abnormalities of the breast with sensitivities (ability to identify) of 95% to 100% and specificities (verify) of 87% to 90%. Currently, it is widely recognized that mammograms miss an estimated 20 to 30% of the breast cancers.