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

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.

Comparison of the diagnostic performances of circulating tumor cells and the serum tumor markers CEA,CA125,and CA15-3 for breast cancer:a retrospective case-control study

Objective:Serum tumor markers are seldom considered as diagnostic biomarkers for breast cancer because they lack good sensitivity or specificity.This study aimed to evaluate whether a combination of circulating tumor cells(CTCs)and the serum tumor markers carcinoembryonic antigen(CEA),cancer antigen(CA)125,and CA15-3 might improve their diagnostic performance.Methods:We performed a retrospective case-control study of patients with breast cancer or benign breast diseases(BBD)and healthy female donors(HDs)who underwent preoperative CTC detection and serum tumor marker tests between December 2017 and November 2018.CTC detection and serum tumor marker test results were collected from 177 breast cancer patients,64 patients with BBD,and 20 HDs.Correlations between CTC,CEA,CA125,or CA15-3 and participants’clinical characteristics were then analyzed.The diagnostic performances of CTC,CEA,CA125,and CA15-3 were estimated using the area under the receiver operating characteristic curve(AUC).This study was approved by the Institutional Review Board of Sun Yat-sen Memorial Hospital of Sun Yat-sen University,China(approval No.[2018]kuaishendi(75))on May 24,2018.Results:CTC,CEA,and CA15-3 were able to distinguish breast cancer patients from controls(BBD+HDs)(P<0.0001,P=0.0006,and P=0.0086,respectively).CTCs were associated with tumor size(P=0.0275)and lymph node involvement(P=0.0373),while CA15-3 was correlated with cancer stage(P=0.01)and lymph node involvement(P=0.001).The AUCs of CTCs,CEA,CA125,and CA15-3 were 0.845,0.623,0.477,and 0.58,respectively.CA125,with AUC<0.5,was not considered a biomarker for breast cancer.CEA and CA15-3 had low sensitivities(<10%)but high specificities(>98%).Combination with CTC improved the diagnostic performances of CEA and CA15-3 for breast cancer.CTC_CA15-3 had better diagnostic performance than CTC_CEA,with an AUC of 0.874,a sensitivity of 0.757,and a specificity of 0.905.Conclusion:CTCs,CEA,and CA15-3 are potential diagnostic biomarkers for breast cancer.The diagnostic performance of CEA and CA15-3 may be improved by combination with CTCs.