Abstract P5-03-03: A blood-based proteomic Videssa® breast assay performs comparably in women with dense and non-dense breasts
Authors: Silver M , Tran Q , Gordon K , Benson KL , Henderson MC , Letsios E , Mulpuri R , Reese DE 
Published: March 2017

Breast density is associated with reduced imaging sensitivity and specificity for breast cancer (BC). Women with dense breasts are at a four- to six-fold increased risk of developing BC. A biochemical approach that is not affected by density would provide an additional tool to health-care professionals who are managing women with dense breasts and suspicious imaging findings. Videssa® Breast, a combinatorial proteomic biomarker assay, comprised of Serum Protein Biomarkers (SPBs) and Tumor –Associated Autoantibodies (TAAbs) integrated with clinical characteristic data to produce one diagnostic score that reliably detects BC was recently developed as an adjunctive tool to imaging. The goal of this study was to determine whether the diagnostic performance of Videssa® Breast was impacted by breast density.

Provista-001 enrolled 351 participants under the age of 50 years with no prior history of breast biopsy, and Provista-002 cohort one enrolled 210 participants under the age of 50 years with no history of breast biopsy within six months; all participants were assessed as BI-RADS 3 or 4. Breast density status was retrospectively obtained for participants; the four American College of Radiology breast density categories (a, b, c, and d) used for clinical reporting were applied. Serum was collected and tested with Videssa® Breast. Women were categorized into Dense, which included categories c and d, and Non-dense, which included categories a and b, groups.

To understand the performance of Videssa® Breast in women with dense breasts, the clinical sensitivity, specificity, NPV and PPV were evaluated in the dense and non-dense groups from the comprehensive Provista-001 and Provista-002 set (n=545). Of these 545, breast density information was available for 454; 62.6% (n=284) were categorized as having dense breasts and 37.4% (n=170) were categorized as having non-dense breasts. The sensitivity of Videssa® Breast in the non-dense and dense groups was 92.3% and 88.9%, respectively, and the specificity in the non-dense and dense groups was 86.6% and 81.2%, respectively. No significant differences were observed in the sensitivity (p=1.0) or specificity (p=0.1783) of Videssa® Breast in detecting BC in participants with non-dense breasts compared to those with dense breasts. The NPV in both groups exceeded 99%; the PPV was similar across groups.

In summary, this study demonstrates that Videssa® Breast has comparable performance in women with dense and non-dense breasts. Videssa® Breast demonstrates high sensitivity and specificity for detecting BC (Grades I through III), irrespective of density status. Videssa® breast provides an additional tool for health-care providers when women with dense breasts present with challenging imaging findings. In addition, Videssa® breast provides assurance to a woman with dense breasts that she does not have BC, potentially reducing further anxiety in this higher risk patient population.

Citation Format: Silver M, Tran Q, Gordon K, Benson KL, Henderson MC, Letsios E, Mulpuri R, Reese DE. A blood-based proteomic Videssa® breast assay performs comparably in women with dense and non-dense breasts [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-03-03.