The study authors stressed the critical need for follow-up with patients who present with abnormal results on a screening mammogram. Standards of care and practice guidelines require further imaging studies before an invasive procedure such as breast biopsy, when the screening mammogram uncovers something suspicious.

They further recognized unmet medical need for highly effective exam tools that could exclude patients whose suspicious breast masses are benign before they are subjected to invasive diagnostic procedures. Breast biopsies have been found to show a false-positive rate following diagnostic screening procedures as high as 71 percent in the United States according to the National Cancer Institute3, translating to an annual cost of $2.18 billion in biopsy procedures that might have been avoided.


"The costs to the healthcare system are secondary to the psychological impact on women who are told that their mammogram and ultrasound were inconclusive, and that a biopsy is required to rule out cancer," says A. Thomas Stavros, MD, FACR, FSRU, FRANZCR, Professor Specialist, Department of Radiology University of Texas Health Sciences Center and Chief Medical Officer of Seno Medical, San Antonio, TX.

Stavros continued, "Conscientious clinicians rightly want to confirm that a mass is not malignant, so the guidelines and clinical practice aren't at fault. It's simply that technology – as advanced as it has become – still needs further refinement to provide better specificity without sacrificing sensitivity and to engender increased diagnostic confidence for the clinician. There are significant volumes and costs of procedures required to reach a definitive, 'yes,' that breast cancer does or does not exist."

"Our findings bring a national spotlight on the current diagnostic procedure journey faced by patients and providers in order to have confidence in the evidence of a woman's risk of breast cancer," says Jay Margolis, PharmD, Senior Research Scientist, Life Sciences, Value Based Care at IBM Watson Health and senior author for the study. "Recalling a woman for subsequent imaging procedures that may not be truly needed places significant burdens on the patient, her family, and her career, with substantial costs to the healthcare system."


About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical's Imagio™ breast imaging system fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the Imagio OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical's OA/US imaging technology, visit www.SenoMedical.com.

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