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Will breast tomosynthesis completely replace 2-D mammo?

by Christina Hwang, Contributing Reporter | July 04, 2016
From the July 2016 issue of HealthCare Business News magazine


Dr. Debra Monticciolo, fellow of the American College of Radiology, and chair of the American College of Radiology Breast Imaging Commission, agrees and says that insurers will eventually have to respond to the demand for a better technology, and when something has proven benefits, there will be pressure from women themselves saying “this is the technology we want.”

Options in the market
Manufacturers are making strides to ensure they bring increasingly effective breast imaging technology to the marketplace so providers can achieve better outcomes for their patients. A report from analysts at MarketsandMarkets estimates breast imaging will become a $4.14 billion market by 2021, at a compound annual growth rate of 8.5 percent from 2016 to 2021. Hologic’s Affirm prone biopsy system received FDA approval in April, and became the first 2-D/3-D imaging-guided prone biopsy system to enter the U.S. market. The system allows doctors to better handle biopsies for subtle lesions or faint calcifications that are only identifiable using 3-D exams.

A review conducted by the York Health Economics Consortium, a consultancy and research company, confirmed that the Hologic system is more accurate than just a 2-D exam, with doctors being able to screen for breast cancer with 41 percent more accuracy. Additionally, patients had a 40 percent less chance of being called back for additional screening.

The radiation dose that a woman receives during screening can possibly double if she undergoes a 2-D and 3-D mammography exam. To address this, software can be used to create a 2-D image from the 3-D image, and this synthetic 2-D takes the place of a 2-Donly exam, resulting in lower dose to a patient. Hologic has a product that received FDA approval in 2013 — C-View 2-D imaging software. C-view images are generated from the 3-D tomosynthesis data acquired during the mammography exam, so a patient does not have additional 2-D exposure.

In 2014, GE received FDA approval for SenoClaire, a breast imaging with 3-D tomosynthesis solution. The SenoClaire performs a low-dose short X-ray sweep around the breast taking nine exposures in what the company calls a “step-and-shoot” method of acquisition — that means the tube is stationary at the time of acquisition, which may improve image sharpness.

Siemens Healthineers announced in May that its Mammomat Inspiration and Mammomat Inspiration PRIME edition digital mammography systems can be used as standalone 3-D mammography systems. All other mammography systems on the market require a combination of 2-D and 3-D exams. It is the first and only 3-D digital breast tomosynthesis system to receive FDA approval as a standalone screening and diagnostic tool, according to Jennifer Okken, women’s health product manager at Siemens Healthineers.

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