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