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RENO, Nev.--(BUSINESS WIRE)--SonoCiné, Inc., the leading innovator of Automated Whole Breast Ultrasound (AWBU) screening systems for early detection of breast cancer announced today the publication of two important scientific papers reporting on the effectiveness of SonoCiné AWBU in detecting small cancers not detectable with digital mammography. The papers were presented at the 97th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA 2011).

The first paper, "Automated Ultrasound with Mammography Improves Cancer Detections compared with Digital Mammography Alone," was presented by Judy Dean, MD, from Santa Barbara, CA. Dr. Dean is one of the co-authors of the multi-center trial published in 2010(1), which compared mammography alone with mammography plus SonoCiné AWBU. In this study, which included both analog and digital mammography, adding the SonoCiné AWBU examination resulted in the detection of twice as many cancers as mammography alone, and the detection of significantly smaller cancers.

Dr. Deans new report includes 3,778 patients with only digital mammography and again shows significant improvement in cancer detection with the addition of SonoCiné AWBU. The detection of 4.5 cancers per 1,000 studies for digital mammography alone increased to 7.9 per 1,000 when the findings of the SonoCiné AWBU examinations were added. For invasive cancers, the average size of cancers detected with mammography alone was 14 mm, while the average size of the additional cancers detected with SonoCiné was 9 mm.

Dean reports that "Automating the scanning makes it practical because this can be done by technical personnel. The radiologist spends only a few minutes to interpret and report the examinations, instead of having to both perform and report the examinations." According to Dean, "I treat AWBU examinations as screening studies. Patients with abnormal findings are recalled for work-up in the same way findings on a screening mammogram would be worked up prior to biopsy." In her series, the Positive Predictive Value (PPV) of biopsies resulting from digital mammography findings was 50% (17/34), while the PPV of biopsies resulting from SonoCiné AWBU findings was 43.6% (13/30).

The second paper reporting on the clinical use of SonoCiné Automated Whole Breast Ultrasound was presented by Belinda Barclay-White, MD from Scottsdale, AZ. "Automated Breast Ultrasound Screening in Women with Digital Mammographically Dense Breasts: First Years Experience." Barclay-White reported that in her first 594 patients there was a diagnostic yield of 3.4 per 1,000 for digital mammography, and 8.4 per 1,000 for digital mammography and SonoCiné AWBU combined.

"SonoCiné AWBU enables me to detect most of the cancers missed by mammography in women with dense breasts," said Barclay-White and added, "This technology has the potential to dramatically improve breast cancer screening for these women."

Reference:

1. Kelly KM, Dean J, Comulada WS, Sung-Jae L: "Breast Cancer Detection Using Automated Whole Breast Ultrasound and Mammography in Radiographically Dense Breasts" European Radiology (2010) 20: 734–742

About the SonoCiné AWBU system and SonoCiné, Inc:

The SonoCiné system was invented and engineered specifically for integration with standard ultrasound scanners to provide radiologists with an effective, systematic and automated screening examination for the early detection of mammographically occult breast cancers in asymptomatic women.

The high cancer detection performance reported by clinical users of SonoCiné AWBU is the result of a number of important system characteristics. These include separating the image data acquisition from the radiologists review, automating and computer-controlling the screening of the entire breast and lower axillary lymph nodes, and maximizing lesion visualization and detectability using the companys proprietary dynamic review software. The risk-free procedure is fully documented, quality-controlled and pain-free.

Unlike mammography, the SonoCiné AWBU procedure requires no breast compression or x-ray radiation, and unlike MRI and MBI/BSGI, it requires neither a contrast agent, nor a radioactive tracer.

Based in Reno, NV, SonoCiné, Inc., is a privately owned research, development and manufacturing company with focus on early breast cancer detection.

Posted by Sean Fenske, Editor-in-Chief, MDT

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