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Breast Cancer Diagnosis

Physicians and researchers in the field widely acknowledge that screening and proper diagnosis are essential for effective treatment and management of the disease. In March 1997, the American Cancer Society expanded its breast cancer screening guidelines to include yearly mammograms for all women over 40 years of age. The National Cancer Institute has also adopted these guidelines.

Mammography has been in use for over 75 years for both screening and diagnostic applications. In cases that are referred for biopsy, mammography has a specificity (ability to detect a benign lesion) of only 20%, or less in younger women. It is a well-established modality and considered the industry standard against which other modalities are measured, but because of its substantial specificity limitation, there is a great need for an improved diagnostic tool to non-invasively differentiate between malignant and benign lesions.The necessity to solve these problems has heightened the Company's sense of urgency in obtaining the necessary regulatory approvals and introducing the product into the marketplace.

 
 


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