SAN ANTONIO, Jan. 8, 2019 /PRNewswire/ -- Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses, today provided a summary of key 2018 data publications and presentations that demonstrate the clinical utility and healthcare economic benefits of its proprietary, cutting-edge technology.

"Multiple publications and presentations over the course of 2018 substantially strengthen the body of evidence emphasizing the economic costs of unnecessary breast biopsies and the power of our Imagio® Breast Imaging System to potentially reduce the number of these procedures," said Thomas Umbel, President and CEO of Seno Medical. "This growing evidence base further advances the compelling value proposition that Seno Medical offers to patients, physicians, and payers. We believe this robust body of evidence will help to position the Imagio system as a sound diagnostic tool for the breast imaging community. The selection of Imagio as a finalist for the 2018 Medtech Insight Awards in the 'Best Proof-of-Value of an Innovation' category demonstrates widespread recognition of our value proposition."

Previously unreported data publications and presentations include:
A cover article in Radiology reporting the results of a landmark study using OA/US imaging to diagnose benign and malignant breast masses. This study, which was based on results from 2,191 breast masses in 2,105 women, found that OA/US increases the specificity of breast mass assessment compared with ultrasound (US) alone. OA/US downgraded 40.8% of benign mass reads, with a specificity of 43.0% compared with 28.1% for US alone. OA/US exceeded US in specificity by 14.9% (P < .0001). Sensitivity for biopsied malignant masses was 96.0% for OA/US and 98.6% for US (P < .0001). The negative likelihood ratio (NLR) of 0.094 for OA/US indicates a negative examination can reduce a maximum US-assigned pretest probability of 17.8% (low Breast Image Reporting and Data System [BI-RADS] 4B) to a posttest probability of 2% (BI-RADS 3).1

A publication in Radiology of a European prospective, multi-center study evaluating OA/US in downgrading suspicious breast masses in 209 patients with 215 breast masses classified as BI-RADS 4a or 4b.2 Results show that 47.9% of benign masses classified as BI-RADS 4a and 11.1% of masses classified as BI-RADS 4b were correctly downgraded to BI-RADS 3 or 2 with OA/US. Two of seven malignant masses classified as BI-RADS 4a at US were incorrectly downgraded, and one of 60 malignant masses classified as BI-RADS 4b at US was incorrectly downgraded for a total of 4.5% false-negative findings. The study authors conclude that benign masses classified as BI-RADS 4a could be downgraded in BI-RADS category with OA/US, which could potentially decrease negative biopsies for cancer and short-interval imaging follow-up examinations, with the limitation that a few masses may be inappropriately downgraded.

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