Optoacoustic imaging developer Seno Medical Instruments released study results indicating that its Seno Imagio breast imaging system improves physicians' ability to rule out breast cancer, compared with traditional ultrasound alone.
Results of the parallel reader study were presented at the Senologic International Society (SIS) World Congress on Breast Healthcare, held October 16-19.
In September, Seno completed active enrollment of 2,100 patients in PIONEER, or "A Pivotal Study of Imaging With Optoacoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound." The results of the study will serve as the basis for the company's premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA).
Readers using Seno Imagio may be able to reclassify benign breast lesions to a lower BI-RADS score so patients can avoid a biopsy on benign masses, the firm said. If confirmed by the prospective, multicenter PIONEER study of Imagio, the predictive model may improve the image reader's ability to characterize solid breast masses as cancerous or benign and spare women with benign lesions from the biopsy process beyond the standard of care, Seno added.
Without the predictive model, the radiologists achieved 11%, 24%, and 25% better specificity than with conventional grayscale ultrasound. With the predictive model, each radiologist achieved 28%, 36%, and 38% better specificity than with conventional grayscale ultrasound.