SAFE, MORE ACCURATE, BREAST CANCER TEST STUDY RELEASED

CHICAGO  -- Breast cancer can be detected more accurately with a radiation-free, non-invasive screening test according to a study described today. The findings, released at the International Contrast Ultrasound Society (ICUS) 27th Annual Conference, found contrast-enhanced ultrasound imaging (CEUS) exams provide more accurate results than either MRI or conventional ultrasound imaging.

In a multi-center study of 351 women in Japan,  CEUS identified focal breast lesions with more accuracy, having fewer false positives and fewer false negatives when compared to MRI and unenhanced ultrasound imaging, according to Dr. Fuminori Moriyasu, medical advisor for the study at Tokyo Medical University.

"CEUS is an excellent diagnostic imaging tool that helps differentiate benign from malignant tumors without exposing patients to ionizing radiation," Dr. Moriyasu said. His study led to the recent approval in Japan of Sonozoid, an ultrasound contrast agent marketed by GE Healthcare.
 
Sonozoid is a liquid suspension of tiny gas microbubbles that can be injected into a patient's arm vein during an ultrasound exam to enhance the ultrasound signals, improving the clarity and accuracy of the ultrasound image.  Sonozoid is expelled from the body within minutes.

"These findings provide an exciting new radiation-free option for detecting breast cancer and assessing treatment," according to Dr. Sharon Mulvagh, a cardiologist at Mayo Clinic and women's health researcher.  The Japanese study is especially noteworthy because other studies show that CEUS can lower the overall cost of diagnostic imaging by improving the usefulness of frontline ultrasound scans, thereby reducing the need for redundant downstream testing.

"The potential impact of this is huge for women," Dr. Mulvagh added. She said that CEUS is readily accessible, safe and avoids exposing women to radiation.

The Phase 3 study showed that Sonozoid was accurate in 87% of patients, compared to 69.5% accuracy of MRI and 65.5% accuracy of conventional ultrasound without a contrast agent, according to Dr. Moriyasu.

“A new approval for characterization of breast masses holds great promise for women’s health”, added Stephanie Wilson, a radiologist at the University of Calgary and a Vice president of ICUS.
 
Sonozoid is not approved for use in the United States.  However, two other ultrasound contrast agents -- Optison (GE Healthcare) and Definity (Lantheus Medical Imaging) -- are FDA-approved for cardiac imaging in the United States.  In addition, Sonovue (Bracco) is used in Europe and elsewhere for imaging tumors and organ systems throughout the body. Additional applications of these ultrasound contrast agents are under review worldwide.

ABOUT ICUS: ICUS is an international, multi-disciplinary, not-for-profit medical society that is exclusively dedicated to advancing the use of contrast enhanced ultrasound diagnostic imaging to improve patient care worldwide. Founded in September 2008, ICUS brings together physicians, scientists, and other ultrasound imaging professionals from over 55 countries. ICUS members represent diverse specialties such as cardiology, radiology, vascular imaging, gastro-intestinal imaging, oncology, OB-GYN, and hepatology. For more information about ICUS, please visit www.icus-society.org/2013site.

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ICUS is the world’s only professional society exclusively devoted to contrast-enhanced ultrasound (CEUS) medical imaging technology.

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