Abstract P1-02-09: CDA screening technology for multi-ethnic group, early stage breast cancer screening
Authors: Tao H , Lin Y , Liu C , Dou J , Sheng Y , Wu J , Hu W , Li Y , Tang X , Yu C , Du X 
Published: May 2019

Background: Breast cancer is the second leading cause of death from cancer in American women. Current breast cancer screening technologies have issues with poor sensitivity for early stage breast cancer, high false positives, radiation side effects, etc. Cancer Differentiation Analysis (CDA) technology is a blood-sample based, multi-level, multi-parameter diagnostic method which detects signals from both proteins, cells, and to some extent, molecular level, in which multiple aspects of information are collected to improve diagnostic accuracy. CDA technology has been investigated as a viable clinical utility in breast cancer screening, particularly for early stage breast screening with clear advantages (both whole blood and serum can be used, ability to detect early, easy, simple, no side effects, and high degree of sensitivity and specificity).

Methods: In this study, the human subjects involved are Caucasians, with serum samples of 44 pathologically confirmed breast cancer patients and 34 healthy individuals from 3 blood bank centers in the USA, of which 40 cases were stageIbreast cancer, 2 cases were stageII, and the other 2 cases were stage III breast cancer. CDA data of 44 breast cancer patients and 34 healthy individuals were collected in US lab and analyzed using SPSS, and the results were shown in the table below. Results from the above study was compared with a clinical study on Asian group with data collected in lab in China using CDA technology.

Results: The average CDA value of all breast cancer and stageIbreast cancer samples, and controls were 45.99, 45.76 and 42.36 (rel. units) respectively (see Table 1). Both breast cancer and stageIbreast cancer could be significantly distinguished from the control group (p &lt; 0.001) (Table 2). For stageIbreast cancer vs. control group, Area under ROC curve was 0.727, sensitivity and specificity were 62.5% and 82.4% respectively, which is higher than a typical mammogram. To compare with different ethnic groups, data collected on an Asian group is also shown in Table 2, which showed that overall, AUC, sensitivity and specificity are comparable (some difference may be attributed to sample type difference (whole blood vs. serum)) for early stage breast cancer patients for those two ethnic groups, demonstrating that CDA technology can be extended to multiple ethnic groups.

Conclusions: CDA screening can be extended to different ethnic group including Caucasian and Asian with good sensitivity and specificity for stageIbreast cancer.

We thank Ugur Basmaci, Sunsil Pandit and Sharon Vorse-Yu for their support.

Table 1Summary of CDA Test ResultsGroupSample SizeAge RangeAge MeanAge MedianCDA Mean (rel. units)CDA Median (rel. units)CDA STDEVControl3436 -79575742.3642.652.75Breast Cancer4436 – 77606145.9946.504.22Stage I Breast Cancer4036 – 77606145.7645.554.26Stage II Breast Cancer251 – 64585847.0547.054.88Stage III Breast Cancer262 – 75696949.5049.502.55

Table 2AUC, Sensitivity and Specificity of Control vs. Stage I Breast CancerStage I Breast Cancer vs. ControlArea Under the CurveSensitivitySpecificityCaucasian (Stage I)0.72762.5%82.4%Asian# (Stage I)0.87680.0%80.0%# Whole blood samples. 10 stage I breast cancer samples and 25 control samples

Citation Format: Tao H, Lin Y, Liu C, Dou J, Sheng Y, Wu J, Hu W, Li Y, Tang X, Yu C, Du X. CDA screening technology for multi-ethnic group, early stage breast cancer screening [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-02-09.