Clinical validation of the novel CLIA-CA-62 assay efficacy for early-stage breast cancer detection

Marina Sekacheva; Alexander Boroda; Anastasia Fatyanova; Alexander Rozhkov; Nikolai Bagmet

doi:10.3389/fonc.2023.1009863

Clinical validation of the novel CLIA-CA-62 assay efficacy for early-stage breast cancer detection

Front Oncol. 2023 May 3:13:1009863. doi: 10.3389/fonc.2023.1009863. eCollection 2023.

Authors

Marina Sekacheva¹, Alexander Boroda¹, Anastasia Fatyanova¹, Alexander Rozhkov¹, Nikolai Bagmet²

Affiliations

¹ World-Class Research Center "Digital Biodesign and Personalized Healthcare", Sechenov First Moscow State Medical University, Moscow, Russia.
² Department of Biliary, Hepatic, and Pancreatic Surgery, B.V. Petrovsky Russian Scientific Center of Surgery, Moscow, Russia.

Abstract

Background: Without organized screening programs up to 60-70% of breast cancers are diagnosed at advanced stages that have significantly lower five-year survival rate and poorer outcomes, which is a serious global public health problem. The purpose of the blind clinical study was the assessment of the novel in-vitro diagnostic chemiluminescent CLIA-CA-62 assay for early-stage breast cancer detection.

Methods: Blind serum samples of 196 BC patients with known TNM staging, 85% with DCIS, Stage I & IIA, and 73 healthy control subjects were analyzed with the CLIA-CA-62 and CA 15-3 ELISA assays. Results were also compared to the pathology findings and to published data from mammography, MRI, ultrasound, and multi-cancer early detection test (MCED).

Results: The CLIA-CA-62 overall sensitivity for BC was 92% (100% for DCIS) at 93% specificity and it decreased in invasive stages (Stage I=97%, Stage II=85% and Stage III=83%). For the CA 15-3 assay sensitivity was 27-46% at 80% specificity. Sensitivity for mammography was 63-80% at 60% specificity, depending on the stage and the parenchymal density.

Conclusion: These results demonstrate that CLIA-CA-62 immunoassay could prove useful as a supplement to current mammography screening and other imaging methods, thus increasing the diagnostic sensitivity in DCIS and Stage I breast cancer detection.

Keywords: CA 15-3; CA-62; CLIA; breast cancer; ductal carcinoma in-situ (DCIS); mammography; screening; tumor.

Grants and funding

This work was financed by the Ministry of Science and Higher Education of the Russian Federation within the framework of state support for the creation and development of World-Class Research Centers “Digital Biodesign and Personalized Healthcare” №075-15-2022-304.