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Background: Current screening mammography for breast cancer is associated with misdiagnosis in as many as 30% of cases. Objectives: To develop and clinically evaluate a unique autoantibody based protein microarray blood test to improve the accuracy of breast cancer screening. Materials and Methods: A microarray was constructed from commercial antigens and antigens selected from screened cDNA libraries of breast cancer tissue samples. A training set containing 439 healthy controls and 276 biopsy proven breast cancer cases was used to establish a set of separating models between the two groups. These models were used to assign a diagnosis to 285 blind samples from 120 breast cancer patients and 165 healthy controls. Results: The test identified 82 of the 120 breast cancer patients and 160 of the 165 healthy controls. These results can be translated into a sensitivity of 68.3% [CI: 59% -77%] and a specificity of 97% [CI: 93% -99%], with a PPV for this validation set of 94.3% (CI: 87.10% -98.11%), NPV of 80.81% [CI: 74.62% -86.05%] and an AUC of 89.2% [CI: 78% -87%]. Conclusions: The protein microarray can be utilized to reduce the false negative rate of routine screening mammography. Women with a negative mammography and a negative blood test can be reassured and encouraged to continue routine breast cancer screening. A positive test should alert the physician about the possible presence of a breast cancer not detected by routine screening mammography and drive to perform additional investigation, such as breast ultrasound and MRI.

An Autoantibody Based Protein Microarray Blood Test to Enhance the Specificity of a Negative Screening Mammogram