Annual Cost of False-Positive Breast Biopsies Exceeds $2 Billion According to Recent Study

–  Publication in ClinicoEconomics and Outcomes Research estimates nearly $8 billion annually in expense for additional breast diagnostic testing, underscoring market need for improved breast diagnostic tools –

SAN ANTONIO, May 31, 2018 – False-positive breast biopsies in the United States cost the healthcare system more than $2 billion per year, according to findings released from a new study in ClinicoEconomics and Outcomes Research, conducted by a team of health outcomes research scientists at IBM Watson Health™ in collaboration with Seno Medical’s Chief Medical Officer, A. Thomas Stavros, MD.

The study analyzed recent data focusing on diagnostic breast imaging, biopsies, and other diagnostic procedures performed for patients recalled for follow-up after suspicious findings from initial screening mammography or breast examination. Such follow-up procedures are ordered by clinicians largely because current tools often cannot provide diagnostic certainty in identifying cancerous breast masses. The study looked at how often the follow-up procedures were performed, on what volume of patients, the most common sequences in which the procedures were performed, and the associated costs.

Data was collected from a nationally representative sample of 875,000 adult women using real-world encounters from health care claims data from 2011 to 2015, and then projected nationally to estimate that more than 12 million women in the US received follow-up exams each year after suspicious findings. Based on actual payer claims for the women studied, 53.3% of such patients received diagnostic mammograms, 42.4% received diagnostic breast ultrasounds, and 10.3% received biopsies after initial diagnostic procedures. Total costs for these procedures were projected at:

Combined with other follow-up imaging procedures (e.g., tomosynthesis, MRI, others), the data totals nearly $8 billion spent annually for follow-up breast diagnostic procedures. [See Infographic.]

Breast cancer is the most common malignancy among women worldwide and the second leading cause of cancer-related deaths in females, and it is estimated that 266,120 new cases of invasive breast cancer will be diagnosed in women in 2018.2 Survival rates have increased steadily over recent decades as earlier detection enables treatment at earlier stages when treatment is more effective and less costly. However, many organizations differ on timing (annually, bi-annually) and ages for screening (to begin at age 40 or 50 years, screening after age 74 years), with varying opinions on how to best balance breast cancer screening costs with rates of detection, rates of false-positives or over diagnoses, and reduction in mortality.1

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

1 Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of Utilization Patterns and Associated Costs of the Breast Imaging and Diagnostic Procedures After Screening Mammography. ClinicoEconomics and Outcomes Research 2018:10 157-167.

2 American Cancer Society, Current year estimates for breast cancer, January 4, 2018

3 NCI-funded Breast Cancer Surveillance Consortium (HHSN261201100031C). Downloaded from the Breast Cancer Surveillance Consortium Web site – Accessed January 23, 2017.

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