Breast Cancer Monoclonal Antibody for CLIA & ELISA Immunoassay Development
CA15-3 (Cancer Antigen 15-3) measures circulating shed fragments of MUC1 — a heavily O-glycosylated transmembrane mucin overexpressed and aberrantly glycosylated by breast cancer cells. CA15-3 is the primary serum biomarker for breast cancer monitoring per ASCO, ESMO, and ABC consensus guidelines, with sensitivity of 60–80% for metastatic disease and 15–35% for early-stage breast cancer.
CA15-3 immunoassays require antibodies targeting two distinct MUC1 epitope types: carbohydrate epitopes (glycan-dependent, recognised by 115D8-like and MA695-like clones) and peptide epitopes (glycan-independent, recognised by DF3-like and MA552-like clones). Sekbio supplies the broadest CA15-3 antibody panel available — 7 clones (S01-A108-1M through S01-A108-5H) supporting both Roche Elecsys-equivalent (1M + 3M) and CanAg EIA-equivalent (4M + 3M) configurations.
Humanized variants (S01-A108-2H, S01-A108-5H) are available for HAMA-mitigated CLIA platform development. CA15-3 is indicated for systemic therapy monitoring and recurrence surveillance in stage II–IV breast cancer. Normal reference: <25–30 U/mL.
7 clones covering carbohydrate and peptide MUC1 epitopes, supporting Roche and CanAg reference-equivalent sandwich pairs.
| Catalog No. | Product Name | Format | Epitope Type | Reference Clone | Recommended Role | Storage |
|---|---|---|---|---|---|---|
| S01-A108-1M | Mouse Anti-CA15-3 mAb | Mouse mAb | Carbohydrate | Similar to 115D8 | Capture — Roche pair | +2°C to +8°C |
| S01-A108-2M | Mouse Anti-CA15-3 mAb | Mouse mAb | Peptide (DTRPAPG) | Similar to DF3 | Detection alternative | +2°C to +8°C |
| S01-A108-2H | Humanized Anti-CA15-3 mAb | Humanized mAb | Peptide (DTRPAPG) | Similar to DF3 | Detection (HAMA-mitigated) | +2°C to +8°C |
| S01-A108-3M | Mouse Anti-CA15-3 mAb | Mouse mAb | Peptide (DF3) | Similar to MA552 | Detection — Roche & CanAg pairs | +2°C to +8°C |
| S01-A108-4M | Mouse Anti-CA15-3 mAb | Mouse mAb | Carbohydrate | Similar to MA695 | Capture — CanAg pair | +2°C to +8°C |
| S01-A108-5M | Mouse Anti-CA15-3 mAb | Mouse mAb | Peptide (DF3) | Similar to MA552 | Detection alternative | +2°C to +8°C |
| S01-A108-5H | Humanized Anti-CA15-3 mAb | Humanized mAb | Peptide (DF3) | Similar to MA552 | Detection (HAMA-mitigated) | +2°C to +8°C |
Roche-equivalent pair: S01-A108-1M (capture, 115D8-like) + S01-A108-3M (detection, MA552/DF3-like). CanAg-equivalent pair: S01-A108-4M (capture, MA695-like) + S01-A108-3M (detection). MOQ 1 mg. Contact info@sekbio.com for pair selection guidance.
The broadest CA15-3 antibody panel available — 7 clones, 2 reference-equivalent pairs, and humanized variants from a single ISO 13485 supplier.
S01-A108-1M (carbohydrate capture, similar to 115D8) + S01-A108-3M (peptide detection, similar to MA552/DF3) mirrors the epitope configuration of the Roche Elecsys CA15-3 assay. Clinical correlation data against Roche Elecsys CA15-3 confirms quantitative equivalence across the 0.1–300 U/mL clinical range, supporting Roche-traceable IVD assay development.
S01-A108-4M (carbohydrate capture, similar to MA695) + S01-A108-3M (peptide detection) replicates the CanAg CA15-3 EIA reference pair. The MA695 + MA552 configuration is widely used in European laboratory medicine for CA15-3 method calibration traceability, enabling OEM manufacturers to produce CanAg-traceable CLIA and ELISA reagents.
S01-A108-2H and S01-A108-5H are humanized variants of their respective mouse mAbs, retaining identical DF3/peptide epitope specificity. For CLIA platforms where HAMA interference is a documented concern, substituting mouse detection antibodies with humanized variants reduces false-positive CA15-3 elevations in biologic-treated breast cancer patients under active surveillance.
CA15-3/MUC1 presents both carbohydrate-dependent (115D8, MA695 recognition) and glycan-independent peptide (DF3, MA552 recognition) epitopes. Using antibodies targeting both epitope types in a sandwich pair maximises recognition of the full CA15-3 MUC1 isoform population present in patient serum, reducing the risk of missing cancer-specific glycoforms.
Sekbio CA15-3 antibody pairs are validated to quantify across the 0.1–300 U/mL analytical range required for clinical CA15-3 assays, covering normal (<25 U/mL), borderline (25–100 U/mL), and high-concentration metastatic disease (>100 U/mL) values with <10% CV at the clinical decision cut-off.
All 7 CA15-3 clones manufactured under ISO 13485 QMS with inter-batch CV <10%. Certificate of Analysis with SEC-HPLC purity and functional binding activity data provided per lot. Gram-scale OEM supply for production; biotinylated, enzyme-conjugated, and colloidal gold formats available on request.
CA15-3 is indicated for monitoring systemic therapy (endocrine therapy, chemotherapy, HER2-targeted therapy) response in stage II–IV breast cancer. A rising CA15-3 trend (>25% increase confirmed on repeat testing) indicates disease progression or treatment failure per ESMO and ASCO guidelines. CLIA assays using Sekbio's antibody pair provide the precision needed for serial CA15-3 trend analysis.
During the first 5 years post-treatment, rising CA15-3 may precede clinical or radiological evidence of breast cancer recurrence by weeks to months. Serial CA15-3 testing during surveillance enables earlier reinstatement of systemic therapy. ELISA or CLIA using Sekbio's CA15-3 antibody pair supports post-treatment monitoring programs in oncology clinics globally.
In metastatic breast cancer (MBC), baseline CA15-3 correlates with tumour burden and independently predicts overall survival. Very high CA15-3 (>300 U/mL) is associated with bone, liver, and pleural metastases. CLIA assays using Sekbio's 7-clone panel enable quantification beyond 300 U/mL with appropriate sample dilution, supporting high-range MBC monitoring workflows.
IVD manufacturers developing CA15-3 assays can choose Roche-traceable (1M + 3M) or CanAg-traceable (4M + 3M) pairs with full ISO 13485-compliant documentation. The panel of 7 clones enables systematic pair optimisation for unique assay performance targets. Humanized variants provide HAMA management options for global regulatory submissions.
CA15-3 measures circulating shed MUC1 mucin — overexpressed and shed by breast cancer cells. CA15-3 is the primary serum biomarker for breast cancer monitoring (sensitivity 60–80% for metastatic disease) per ASCO and ESMO guidelines. Normal reference: <25–30 U/mL. CA15-3 is used for treatment response monitoring and recurrence surveillance in stage II–IV breast cancer.
7 clones: S01-A108-1M (carbohydrate, 115D8-like), S01-A108-2M (peptide/DTRPAPG, DF3-like), S01-A108-2H (humanized, same epitope as 2M), S01-A108-3M (peptide/DF3, MA552-like), S01-A108-4M (carbohydrate, MA695-like), S01-A108-5M (peptide/DF3, MA552-like), S01-A108-5H (humanized, same epitope as 5M).
Roche-equivalent pair: S01-A108-1M (capture, carbohydrate/115D8-like) + S01-A108-3M (detection, peptide/MA552-DF3-like). This mirrors the 115D8 + DF3 antibody configuration used in Roche Elecsys CA15-3 and cobas CA15-3 reagents. Clinical correlation data available upon request.
CanAg-equivalent pair: S01-A108-4M (capture, carbohydrate/MA695-like) + S01-A108-3M (detection, peptide/MA552-DF3-like). This replicates the MA695 + MA552 antibody pair used in the CanAg CA15-3 EIA reference assay. Validated against CanAg CA15-3 EIA for CanAg-traceable IVD development.
Use humanized variants for CLIA platforms deployed in populations with elevated HAMA from biologic therapy (trastuzumab, pertuzumab, CDK4/6 inhibitors). HAMA can cause false-positive CA15-3 results in mouse antibody-based CLIA assays — a significant concern in breast cancer monitoring where treatment involves frequent biologic agents. Humanized detection antibodies reduce this interference.
MOQ is 1 mg for R&D evaluation. All 7 clones available from 10 mg to gram scale for OEM production. Storage: all mAbs and humanized variants stable at +2°C to +8°C short-term; −20°C long-term. Shelf life 3 years. Contact info@sekbio.com for pair optimisation guidance or visit our Oncology Markers page.
Request the full technical datasheet, pair selection guidance, or discuss OEM supply with our team.