Improved detection Of the MUC1 cancer antigen CA 15-3 by ALYGNSA fluorimmunoassay

Abstract

Breast cancer is the second leading cause of cancerrelated deaths in women worldwide; a prime cancer biomarker to aid in the diagnosis, directed treatment, clinical management, and reoccurrence of this cancer is a MUC1 peptide fragment: cancer antigen 15-3 (CA 15-3). Herein, an immuno-fluorescence assay for CA 15-3 was developed; this ALYGNSA system consists of a protein biolinker (Protein G’) adsorbed onto Poly (methyl methacrylate) (PMMA). The unique interaction of Protein G’ with PMMA, a thermo-plastic polymer has been demonstrated to improve human IgG capture antibody alignment/ orientation and result in greater assay sensitivity. Indeed a previous report (HEALTH 1 325 - 329, 2009) on the shed extracellular domain of HER-2/neu revealed a 10-fold increase in sensitivity of the ALYGSNA assay over a control ELISA assay. Results from this ALYGNSA assay study revealed that a 16-fold increase in detection (≤0.94 U/mL) of CA 15-3 was found in comparison to a commercial control ELISA kit (≤15 U/mL). In conclusion, this enhanced sensitivity of the ALYGNSA assay for CA 15-3, may provide insights into the role/function of this biomarker in normal, as well as, breast cancer and other epithelial cancers

Identification of a panel of complex autoantigens (LGALS3, PHB2, MUC1, and GK2) in combination with CA15-3 for the diagnosis of early-stage breast cancer

“…However, there have been few studies focusing on biomarkers. Although there have been many individual biomarkers [1] identified for the diagnosis of early-stage BC, the sensitivity, specificity, and accuracy are not very high, which limits the application of these markers in the clinic. In addition, no complex antigens that have adequate sensitivity and specificity are available for the diagnosis of early-stage BC.…”

“…The early detection of BC allows an appropriate treatment option and thus significantly improves the 5-year survival rate [2]; without proper biomarkers, BC patients could be diagnosed too late for an appropriate treatment option [2]. There have been approximately 13 promising individual biomarkers identified for the detection of BC, among which CA15-3 is overexpressed in >90 % of breast carcinomas and metastases, and the most frequently used and best known biomarker Her2 is only expressed in 20 % of all breast tumors [1]. Therefore, CA15-3 is the most widely used biomarker for monitoring BC and for the early diagnosis of BC metastasis but not for the diagnosis of BC [3].…”

“…Breast cancer (BC), second to lung cancer, is a leading cause of cancer-related deaths in women worldwide [1]. The early detection of BC allows an appropriate treatment option and thus significantly improves the 5-year survival rate [2]; without proper biomarkers, BC patients could be diagnosed too late for an appropriate treatment option [2].…”

Tumor markers and kinetics in prostate cancer: a mini-review

“…Carbohydrate antigen CA15-3 as initially identified as an expression of breast cancer cell proliferation, where it possess about 15%. However, it was later detected in other tumors too, such as lung, bowel or prostate tumors [20,21] .…”