THE PROBLEM: Current screening procedures overlook or misdiagnose approximately 30% of the breast tissue abnormalities & cancers.

Current non-dynamic imaging techniques, have limitations:

• Are minimally effective for women under 40.
• Are minimally effective with dense breast tissue.
• Are only able to detect an abnormality once it is large enough to image.
• Do not offer a sound alternative solution to the mammogram in screening dense breast tissue as required by law in a growing number of states.

Of the 40m mammograms per year in the US and over 1M biopsies, approximately two thirds (over 750,000 biopsies) are negative and potentially unnecessary.

THE SOLUTION: The First Warning System early screening protocol focuses on measuring the biological processes of the microenvironment of tumor formation and growth to accurately identify breast tissue abnormalities in young (under 40) and dense breasted patients in an accurate, accessible, and affordable instrument.

PRODUCT: Patented software & hardware.

The First Warning System™ (FWS) system uses a small data collection device placed under a bra to collect 12 hours of breast cell data (dynamic cell chaos). Circadian rhythm-based temperature variances of cell cycles are measured to identify abnormalities at the earliest stages of cell augmentation. Powerful predictive analytic software analyses the tissue data producing an object result to the physician to enable a sound and robust clinical decision from the physician and patient.

CORE TECHNOLOGY:

The power in the FWS is the predictive analytic software, CAPP (Computer Aided Physiological Profile), developed in conjunction with Nanyang Technological University and Lytix, Inc., the FWS employs a series of algorithms and neural networks to identify and categorize abnormal patterns in otherwise healthy cellular behavior within the breast delivering an accurate and reproducible automated result to the attending physician.

CORE SCIENCE

Transitional phases of metabolic development activity can be identified pathologically, genetically and biochemically. As normal cells begin the process of tumor generation, each phase exhibits a distinct, measurable, dynamic thermal chaos profile of tissue: normal, benign, suspicious, cancer in-situ and cancer.

CLINICAL TRIALS: Three trials completed.

Over 650 women tested in clinical trials have achieved promising results in sensitivity, specificity and accuracy (Positive Predictive Values) as compared to current screening modalities that are approximately 70% accurate with the disadvantages of compression, radiation and more narrow population applications. The FWS is preparing for a final validation round of a targeted clinical study to ensure reproducible results can be expected with the state-of-the art 4th generation device and software.

MEDICAL ECONOMICS: The FWS is a cost effective system that saves lives, delivers reduced healthcare costs, and is more patient-friendly than current protocols.