Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

Prospective, serially-recruited, blinded and unblinded, validation study to test that the
adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy
that is significantly better than x-ray mammography alone. Healthy volunteers and patients
scheduled for tissue biopsy/excision of a suspicious breast lesion will be enrolled. Reader
Studies will be performed in which interpreting investigators will perform blinded
mammography interpretations, and reinterpretations of mammography and SoftScan
interpretations. Diagnostic accuracy will be calculated using tissue histopathology as the
reference standard.

Inclusion Criteria:

Women between the ages of 20 and 80 years of age, who are either healthy or who are
scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion
for histopathologic diagnosis.

Exclusion Criteria:

For the Healthy Volunteers Population,

- subjects with a history of minor breast procedures involving either breast;

- subjects with a history of major breast procedures involving either breast;

- subjects with a history of significant acute breast abnormalities involving either
breast; and

- subjects with a history of significant chronic breast abnormalities involving either
breast; and

For Referred For Biopsy Population,

- subjects with a history of minor breast procedures involving either breast that were
performed within 6 months prior to enrollment or which have not completed active
healing at the time of enrollment;

- subjects with a history of major breast procedures involving either breast;

- subjects with a history of significant acute breast abnormalities involving either
breast which have not completed active healing or resolution within 6 months prior to
enrollment; and

- subjects with a history of significant chronic breast abnormalities involving either
breast.