New Study Suggests Integrating Multiple Types of Protein Biomarkers Increases Accuracy of Early Breast Cancer Detection

• When serum protein biomarker data were used independently, clinical sensitivity and specificity for detection of breast cancer were 74.7% and 77.0%, respectively.
• When tumor-associated autoantibody data were used independently, clinical sensitivity and specificity for detection of breast cancer were 72.2% and 70.8%, respectively.
• When tumor autoantibody and serum protein data were used together, clinical sensitivity and specificity for detection of breast cancer improved to 81.0% and 78.8%, respectively.

A study published by Henderson et al. in PLOS ONE has shown that a combined assessment of multiple types of protein biomarkers in the blood offers an important advancement for detecting early breast cancer. The study, conducted by Provista Diagnostics, compared the ability of serum protein biomarkers and tumor-associated autoantibodies, either alone or in combination, to detect breast cancer.

The retrospective study evaluated 210 samples, collected prior to biopsy. Samples from a single site (Mercy Women’s Center, which was renamed Mercy Breast Center in June 2016) were used. The specimens included 18 participants with no evidence of breast disease, 92 participants diagnosed with benign breast disease, and 100 participants diagnosed with breast cancer (both invasive breast cancer and ductal carcinoma in situ).

Study Findings

Study results show that when serum protein biomarker data were used independently, clinical sensitivity and specificity for detection of breast cancer were 74.7% and 77.0%, respectively. When tumor-associated autoantibody data were used independently, clinical sensitivity and specificity for detection of breast cancer were 72.2% and 70.8%, respectively. However, when tumor-associated autoantibody and serum protein biomarker data were used together, clinical sensitivity and specificity for detection of breast cancer improved to 81.0% and 78.8%, respectively, demonstrating that a combined proteomic biomarker assay is an important avenue for developing new approaches for detecting breast cancer.

The new data affirm the role of protein biomarkers in addressing the diagnostic challenges associated with imaging, particularly for women whose imaging results fall into category 3 (probably benign finding) or category 4 (suspicious finding) on the American College of Radiology’s BI-RADS (Breast Imaging–Reporting and Data System) scale. When women present with abnormal mammography results and/or have dense breasts, clinicians and patients often face a difficult decision about whether to proceed with additional imaging or biopsy.

David E. Reese, PhD, President and CEO of Provista Diagnostics, said, “This study demonstrates clearly that we can offer better diagnostic technologies to not only detect breast cancer at its earliest, most treatable stage, but also reduce the rate of benign biopsies, which is important in improving care for women who do not have breast cancer.”