SAN ANTONIO, Dec. 9, 2016 /PRNewswire/ -- Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic (OA) technology as a new tool to improve the process of diagnosing breast cancer, today announced results from two analyses of the company's European MAESTRO post-market surveillance study. The two analyses were presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

MAESTRO, a controlled, multi-center, observational, post-market surveillance and clinical follow-up study, was designed to assess the diagnostic value (specificity and sensitivity) of OA to conventional diagnostic ultrasound (CDU) in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed CDU to reach a diagnosis and decision to biopsy followed by an Imagio OA examination. Two hundred female subjects with undiagnosed suspicious masses enrolled in the study.

The first analysis evaluated the correlation between OA imaging results and histologic data of breast masses and found that there was a statistically significant correlation between the OA breast imaging results and those based on histopathologic analysis.
"These studies are an important step forward in the development of noninvasive breast imaging technology. Evaluation of the Imagio system significantly included an independent analysis of the patient's pathology, unparalleled in the pre-release development of any breast imaging technology," said F. Lee Tucker, MD, FCAP and pathologist for the PIONEER study in the U.S. "The findings indicate the Imagio system can provide an accurate and noninvasive differentiation of benign from cancerous breast masses and will be an important means of reducing the number of benign breast biopsies."

The histopathological examination revealed 146 benign masses and 67 malignant masses. For each mass, five pre-determined OA features, three internal features, and two external features were evaluated. The three internal scores (vessels, blush, and hemoglobin) and two external features (capsular boundary zone and peripheral boundary zone) were summed together and separately for testing relationships utilizing traditional histopathology measures. The OA feature scores statistically significantly differentiate between benign and malignant masses and appear to correlate to histologic grade.

The second study, an interim analysis from the MAESTRO study, presented OA imaging downclassification and upclassifciation data, which showed that the Imagio system improved physicians' ability to accurately classify breast masses as malignant or benign compared to using traditional ultrasound. Results from this study were first presented at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI), the second largest conference in the world dedicated to breast cancer imaging, in September 2016 in Paris.

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