Poster Presentation at RSNA Compares Seno Medical’s OA/US Breast Imaging with AI Decision Support to Ultrasound Alone; Finds Significantly Better Specificity to Support Clinical Decision Making Conf

A study presented at the Radiological Society of North America (RSNA)’s annual meeting showed Texas-based Seno Medical Instruments, Inc. (Seno)’s Imagio opto-acoustic ultrasound (OA/US) breast imaging provides significantly better specificity than ultrasound alone. The poster, “Performance of Optoacoustic Ultrasound with an Artificial Intelligence-based Decision Support Tool vs Ultrasound Alone to Classify Benign Versus Malignant Breast Masses: A Pivotal Reader Study,” was presented by Stephen Seiler, MD, Associate Professor, Breast Imaging Division, Department of Radiology at UT Southwestern (Dallas, TX) on November 30.

The study intended to evaluate the gain in specificity using opto-acoustic ultrasound images and an AI-based decision support tool verses ultrasound alone.  The study found that OA/US, when used with a decision support tool, has statistically significant better specificity compared to conventional ultrasound alone.

• Fifteen readers with a wide range of experience in breast imaging from both private practice (8) and academic (7) were involved with the reader study.
• Opto-acoustic ultrasound achieved the primary endpoint in this reader study with specificity significantly higher for OA/US (47.2%) compared to ultrasound alone (38.2%), a difference of 9 percent.
• The observed specificity was 50.1 percent for IUS+OA and 36.6 percent for US. At fixed 98 percent sensitivity, there was a 13.5 percent observed specificity advantage.
• There were 1510 BI-RADS 4A reads of benign masses based on review of US alone.  IUS+OA resulted in the appropriate downgrading of 753 (49.8%) reads to either BI-RADS 2 or BI-RADS 3.

“OA imaging provides different, yet complementary, diagnostic information not provided by conventional ultrasound or its submodalities of Doppler and elastography,” concluded Seiler.

“When used alongside the AI decision support tool, OA imaging has the potential to reduce false positives and thus biopsies of benign masses, versus ultrasound alone, without sacrificing sensitivity.”

Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.[i] Seno’s Imagio technology could mitigate that with its non-invasive OA/US technology to help physicians better differentiate between benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.

Seno’s Chief Executive Officer, Tom Umbel, commented, “The findings by Dr. Seiler and his collaborators further validate the potential for our Imagio Breast Imaging System to improve patient care by reducing unnecessary biopsy procedures and supporting clinical decision making confidence.”

The company’s OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical has shown that the Imagio OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio System, Seno includes an artificial intelligence (AI) decision-support tool (the SenoGram) to aid physicians in interpreting the new images that, along with training and certification, helps radiologists make the transition from ultrasound alone to OA/US imaging.

The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.