Each year, more than 36M mammography procedures are performed in the US alone, in 8,814 certified facilities utilizing 13,404 mammography units. Worldwide estimations exceed 75M procedures performed annually and an install base of 35,000 mammography units.i
Although mammography is considered to be a mature modality, existing for more than 40 years, growth rate in the industry remains relatively high. Over the past 5 years, the number of exams performed annually has grown by 17.4%, suggesting that breast cancer awareness is still on the rise. In addition, despite being the best single screening method, mammography suffers from significant drawbacks:
Over the past decades, mammography's many drawbacks have brought medical imaging companies to continuously try to develop and improve breast imaging solutions - emphasizing the huge market need for a more accurate and well tolerated breast imaging solution. Nevertheless, none of the solutions that have been presented so far have solved the inherent problems of mammography or proved to be superior to it as a screening tool. Indeed, MRI is a relatively good imaging solution, but it has an even greater false positive rate than mammography and its extremely high costs make it irrelevant for screening. FFDM, Computed Radiography (CR) and Computer Aided Diagnosis (CAD) devices that were presented during the past few years have perhaps helped increase throughput and convenience, but have not proved to be more sensitive or specific.
Today, cancer incidence in screening is 0.04%,ii and an estimated 80% of examinees referred to biopsy following x-ray mammography screening prove to be negative for cancer.iii,iv Considering the cost of biopsy, which can range from $550 to several thousand dollars depending on the type of biopsy performed, and with 36M mammography tests performed each year in the US alone, these rates translate into a huge avoidable expense burdening the healthcare system and medical insurance companies.
Nevertheless, while the costs of avoidable biopsies could reach hundreds of millions, the greater burden is caused to the healthcare system and medical insurers by the failure to early detect breast cancer in more than 20% of screening mammography tests. The estimated cost of early detected breast cancer is $15K, but soars to $40K in case the cancer is detected at a more advanced stage; assuming mammography screening "misses" 46,000 patients a year, the avoidable cost of misdetection amounts to more than $1.1B annually.
i Kallergi M., Berman C., et al., Clinical evaluation of a new digitizing device for improved film mammography, Academic Radiology , Volume 11 , Issue 11 , Pages 1242 - 1250.
ii Summary Minutes, Center for Devices and Radiological Health, radiological devices advisory committee, March 4th, 2008. http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4349m1.pdf
iii Silverstein, M.J. et al. "Image-Detected Breast Cancer: State of the Art Diagnosis and Treatment", Journal of the American College of Surgeons. 193 (3), September 2001, pp.297-302.
iv American Cancer Society, "Breast Cancer: Early Detection - The importance of finding breast cancer early". http://www.cancer.org/docroot/CRI/content/CRI-2-6x-Breast-Cancer-Early-Detection.asp