Imagio™ Opto-Acoustic Breast Imaging System Reduces False Positive Breast Exams

Seno Medical Instruments, Inc., says its Imagio™ breast imaging system was more specific than device gray-scale ultrasound alone (US) in differentiating malignant from benign breast lesions and non-inferior to US with respect to sensitivity. This means that OA/US detected a similar number of malignant lesions as US but had a lower rate of false positive malignant diagnoses.


Seno describes itself as the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses. Positive data from PIONEER, a Phase III pivotal trial of its Imagio™ breast imaging system were highlighted during an oral presentation by a principal investigator involved with the study at the Radiology Society of North America 103rd Annual Meeting, taking place November 26 – December 1 in Chicago.

PIONEER was a U.S., prospective, multi-institutional study that enrolled 2,105 women over the age of 18 years. Seven independent readers blinded to clinical and biopsy information conducted 12,283 mass reads. In the intent to diagnose (ITD) population 1808 masses were evaluated in 1,739 subjects (678 malignant, 889 benign, 190 benign with 12-month follow-up).
In the ITD population of 1,739 subjects and 1,808 masses, diagnostic specificity for benign masses was 43% for OA/US and 28.1% for US, corresponding to a 14.9% absolute specificity advantage for OA/US over US (p<0.0001).

Subgroup analyses showed no significant differences in specificity for either OA/US or US based on breast density, mass size, palpability, distance from nipple and depth. Specificity of OA/US was 8.4% higher in patients <50 years of age than in patients aged 60 to <70 years; there was no difference in sensitivity by age group.

Investigator comments

“These data demonstrate that OA/US improved diagnostic specificity compared with US, resulting in reclassification of both benign and malignant lesions,” said Erin Neuschler, M.D., Assistant Professor of Radiology at the Northwestern University Feinberg School of Medicine and the co-principal investigator of the PIONEER study. “The ability to downgrade the BI-RADS assessment of some benign masses may lead to fewer false positive examinations, short-term interval follow-up studies, and benign biopsies, potentially improving the accuracy of the diagnostic work-up and reducing some of the limitations and perceived harms of breast imaging.”

Company comments

“This pivotal trial supports the Imagio system as an important advancement in evaluating breast masses and more accurately differentiating malignant and benign lesions,” said Tom Umbel, CEO of Seno Medical Instruments. “OA/US offers patients and clinicians an alternative diagnostic method that may increase specificity without significantly impacting sensitivity. False positive examinations and negative biopsies increase women’s anxiety, pain and radiation exposure, and are a contributing factor in non-compliance with current breast cancer screening recommendations. The Imagio OA/US system shows the potential to positively affect these concerns and reduce healthcare costs in the process.”

The Imagio™ breast imaging system was designed and is being studied to identify 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 is CE marked in Europe and the subject of a U.S. PMA filing with the FDA.

Source: PR Newswire

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