Abstract 2438: A retrospective pilot study to validate the utility of proteomic biomarkers in the blood for diagnosis of breast cancer

Abstract Background: Previously, three-protein signature (Mastocheck®, Bertis Inc.) from plasma has been launched to overcome the limitation of low accuracy of mammography. In addition, nine-protein signature from serum was newly developed to improve the accuracy of three-protein signature as a blood-based diagnostic tool. This study aimed to validate the diagnostic utility for breast cancer of nine-protein signature with comparison with three-protein signature. Methods: A blood-based test using multiple reaction monitoring (MRM) by mass spectrometry to quantify nine proteins (APOC1, CHL1, FN1, VWF, PPBP, CLU, PRDX6, PRG4, and MMP9) in serum and three proteins (APOC1, CHL1, CA1; Mastocheck®) in plasma was investigated using blood of 30 health women and 30 breast cancer patients. Using the cut-off values confirmed by AI-based deep learning model, we evaluated the sensitivity, specificity, and accuracy of nine- and three-protein signature for detecting breast cancer. Results: Among 60 cases, the sensitivity and specificity of nine-protein signature was 87.9% and 80.7% for diagnosis of breast cancer. These values were 20% and 10% higher than those of three-protein signature, respectively (66.7% of sensitivity and 70.0% of specificity). The accuracy of nine-and three-protein signature was 83.3% and 68.3%. Conclusion: This study demonstrated that nine-protein signature could be a more accurate and effective tool for detecting breast cancer compare to three-protein signature). For a confirmatory study, we need to perform a large scaled validation study in future. Grants: This research was supported by Bertis, Republic of Korea (grant number: NCC 2341770-1) Citation Format: So-Youn Jung, Eun-Gyeong Lee, Jai Hong Han, Seeyoun Lee, Soyeon Shin, Ju Yeon Lee, Sung-Soo Kim, Yumi Kim, Dong-Young Noh. A retrospective pilot study to validate the utility of proteomic biomarkers in the blood for diagnosis of breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2438.