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Seno Medical Instruments Announces Pilot Study Data of Imagio® Breast Imaging System at RSNA 2015 Annual Meeting

Press releases may be edited for formatting or style | December 21, 2015

The Imagio OA breast imaging system was designed to identify the two functional hallmarks of cancer: the presence of abnormal blood vessels (tumor angiogenesis) and the relative reduction in oxygen content of blood that occurs in cancer compared to benign masses and normal tissues. The technology used by the Imagio system is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radio-isotopes, which are required for other modalities that are capable of functional imaging, including magnetic resonance imaging (MRI) or positron emission tomography (PET).

"Diagnostic specificity remains disappointingly low for diagnostic morphologic imaging modalities and reading algorithms that have been optimized to achieve very high sensitivity at the expense of low specificity – which, of course, results in many false positives and generates a high percentage of negative biopsies," said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director of Seno Medical Instruments. "These encouraging results indicate that Imagio can potentially offer physicians a tool to more accurately identify women who do not have breast cancer, and thus, who do not need to undergo invasive and expensive biopsy procedures and/or the stress of undergoing multiple follow-up exams over a two year period, depending upon whether the OA-based downgrade is to BI-RADS category 2 or 3. Reducing false positives and the number of negative biopsies, two of the main perceived and well-publicized 'harms' of breast cancer screening, may help defuse some of the criticisms being put forth by the anti-breast cancer screening movement. As breast radiologists, we can and we should do better in diminishing false positives and reducing negative biopsies. OA is a functional and morphologic diagnostic tool that has the potential to help us achieve better specificity without sacrificing sensitivity, diminish the percentage of negative biopsies generated by breast cancer screening, and to reduce the perceived 'harms' of breast cancer screening."

The RSNA annual meeting is the premiere conference in the world for radiology and medical imaging leaders. It is an international forum of peer-reviewed research, state-of-the-art technology and education for radiologists, radiation oncologists, medical physicists and allied scientists.

According to the American Cancer Society, an estimated 231,840 new cases of invasive breast cancer, along with 60,290 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2015. An estimated 40,290 women in the U.S. are expected to die in 2015 from breast cancer. Only lung cancer accounts for more cancer deaths in women.

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