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Breast Companion®    -    is a computer-aided system (CADx) intended for improving the ACR BI-RADS® assessment of ultrasound images of lesions of the female breast as part of the diagnostic workup


During the last 9 years, in collaboration with the University of California, San Diego (UCSD) School of Medicine and the Veterans Affairs Medical Center (VAMC) San Diego, parts of this software system were tailored to the needs of diagnostic breast ultrasound. The resulting breast assessment assisting software was created and validated under IRB-approved cohorts of cases with available confirmation of the “truth” via needle biopsy or 12-24 months follow-up for benign lesions.

 

CADx - Breast Companion®


Among other features BC enables electronic creation and maintenance of Personal Teaching File. The computerized BI-RADS Assessment & Classification Form and automated Report Generation facilitate streamlining of the interpretation process and contribute to reduction of inter- and intra-reader variability.

CADx produces Computer-aided Lesion Assessment score (CLA),1 which is not designed for lesion prognostication but to assist radiologist in decision stratification as a diagnostic CADx tool. CLA contributes significantly to readers’ level of confidence in scoring of cases with lower level of suspicion (BI-RADS 2 & 3). As a result it helps improve overall reading Accuracy and Specificity of Radiologists without sacrificing Sensitivity


BREAST CADx FOCUS

This diagnostic CADx application targets breast ultrasound, which provides radiologists with a high degree of confidence to differentiate benign lesions. It potentially increases accuracy of reading performance and radiologists' confidence in BI-RADS Assessment, reduces variability of interpretations, and increases ultrasound's role in breast cancer detection and management. The clinically validated and FDA reviewed CADx software can be used standalone or as embedded solution. It also enables electronic Personal Teaching File with lesion imaging library, annotations and findings created by the user.

In the future it can be incorporated into an ultrasound instrument or workstation such that image scoring and CADx assessment is available.


BREAST CADx AVAILABILITY

Our breast ultrasound CADx exists in desktop standalone form or OEM Libraries and is used by individual customers, group practices, hospitals as well as in service bureau environment. "Private Label" customized version is available for customers with desire to have our CADx system to have "look-n-feel" of their other product.


VALIDATION

Two luminary sites directly participated in the clinical development and then clinical validation of the software – Thomas Jefferson University Hospital (including the Breast Imaging Center of TJU) in Philadelphia, PA and the UCSD School of Medicine (lead site) in San Diego, CA. All clinical data, clinical validation and clinical analysis of the results were developed, collected, processed and analyzed in those institutions under their respective IRB protocols.


The development and validation of the Breast Companion software and the clinical data (including but not limited to the Reference Library) was sponsored by multiple NIH/NCI STTR/SBIR, and private foundation research grants with total budgets in excess of $3 million dollars.


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