The Biofield Diagnostic System (BDS) is a noninvasive device that provides an objective diagnosis based on proliferation rates of breast lesions determined from the differentials of electropotentials measured with multiple sensors placed on the surface of the breasts. Methods: In 463 women, there were 299 patients with biopsies of which 150 were benign and 149 malignant. There were 164 patients who were not referred to biopsy and were classified as benign for the analysis yielding a prevalence of 32% in this population. We assessed whether measurements of the breast electrical activity with surface sensors could distinguish benign from malignant breast disease and add value when combining the BDS index with Level of Suspicion (LOS) for imaging or physical exam (PE). Algorithms were developed using Gaussion Classifiers and logistic regression. Performance was verified using leave-one-out cross validation methods in multiple data sets. DeLong's non-parametric method was used for evaluating the prospective data set and computing and comparing the areas under the curve (AUC). Results: We found a highly significant trend of progressive bioelectrical change according to the proliferative characteristics. The AUC of ROC curves generated from the BDS and age was 0.706. The AUC for BDS combined score with mammography/ultrasound or PE were 0.915 and 0.922, respectively. The AUC for imaging LOS and PE LOS were 0.864 and 0.893, respectively. The p-values for the differences between the combined BDS score versus LOS for imaging or LOS for PE are 0.0004 and 0.004, respectively. Conclusion: The BDS provides significant discriminatory information for younger women (18-55 years of age) with palpable lesions. This data was used to receive CE Mark certification of the Biofield Diagnostic System. Results of the Post Market Surveillance (PMS) in progress will be presented.
|Number of pages||1|
|Journal||Breast Cancer Research and Treatment|
|Publication status||Published - 2001|
ASJC Scopus subject areas
- Cancer Research