Background:

Screening for early detection of breast cancer is currently based on breast imaging. Screening mammography, the most commonly used imaging modality, has limited sensitivity, especially in dense breast tissue, and a significant rate of false positive results. An adjuvant blood-test based assay may improve breast cancer detection irrespective of breast density. In previously reported studies, Total Biochemical Infrared Analysis (TBIA) of peripheral blood mononuclear cells (PBMCs) and plasma was able to differentiate between patients with breast cancer and healthy controls or patients with benign breast disease. The TM-B1TM assay is based on TBIA technology and is intended for breast cancer screening. In the present study, the performance of the TM-B1TM assay was evaluated for cancer detection across breast densities.

Patients and Methods:

A total of 220 women were recruited to this IRB approved study: 50 women with newly diagnosed breast cancer, and two control groups – 79 patients with benign findings and 61 patients with no detectable abnormality. Twenty-nine women were withdrawn from the study (for eligibility or technical reasons), and the data presented refer to 190 cases. Breast cancer patients included 6 cases of DCIS, 1 of LCIS, 42 of IDC and 1 of ILC. Ten milliliters of blood were drawn and separated by Ficoll gradient method into PBMCs and plasma. The samples were dried on a zinc selenide optical window and analyzed by a FTIR spectrometer. The spectra were analyzed by the proprietary software TodoSpectra to distinguish between infrared spectra of cancer patients vs. patients with benign findings and healthy controls. The influence of age and breast density on TM-B1TM results were evaluated.

Results:

The TM-B1 assay obtained a sensitivity of 86 % and specificity of 98 % for breast cancer detection. The positive predictive value (PPV) was 95.1% and the negative predictive value (NPV) was 93.5%. Dense breast tissue (BIRADS categories C&D) was present in 55 % of the subjects. The specificity and sensitivity for patients with dense breasts was 99 % and 83 % respectively. No major differences in accuracy of TM-B1 were found due to patients' age.

Conclusions:

TM-B1 in conjunction with current imaging techniques may contribute to early detection of breast cancer by increasing sensitivity and reducing false positive results and unnecessary biopsies. Further studies with larger patient numbers are required and under way to establish the utility of adding the TM-B1 assay to current standard screening for breast cancer.

Citation Format: Allweis TM, Schmitt J, Zelig U. A new additive diagnostic assay for breast cancer screening - Biochemical infrared analysis of immune cells and plasma [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 PD4-01.