1. What Are Oncology Marker Antibody Pairs?

Oncology marker antibody pairs are matched sets of capture and detection monoclonal antibodies used in sandwich immunoassays to quantify tumor-associated proteins released into blood or serum by cancer cells. They are the core raw material components in CLIA, ELISA and LFA diagnostic platforms used in hospitals, oncology clinics and clinical laboratories for cancer screening, diagnosis, staging and treatment monitoring.

Unlike genetic tests, protein tumor markers provide real-time quantitative information about tumor burden and treatment response that can be monitored longitudinally across a patient's cancer journey. The performance of the antibody pair — particularly its sensitivity at low tumor marker concentrations and its ability to avoid cross-reactivity with structurally related non-cancerous proteins — directly determines the clinical utility of the assay.

The most widely used tumor markers in IVD diagnostic platforms include:

  • PSA (Prostate-Specific Antigen): the standard biomarker for prostate cancer screening and post-treatment PSA recurrence monitoring
  • AFP (Alpha-Fetoprotein): primary marker for hepatocellular carcinoma (HCC) surveillance and germ cell tumor monitoring
  • CEA (Carcinoembryonic Antigen): broad-spectrum marker used in colorectal, lung, breast and gastric cancer monitoring
  • CYFRA21-1: the most sensitive serum marker for non-small cell lung cancer (NSCLC), particularly squamous cell carcinoma
  • ProGRP (Pro-Gastrin-Releasing Peptide): the most specific marker for small cell lung cancer (SCLC), with high sensitivity for early-stage disease

One Validation. Consistent Performance. Every Batch.

Sekbio oncology antibodies are manufactured at industrial scale with tight lot-to-lot CV and full ISO 13485-certified traceability. Validate once, produce with confidence.

2. Oncology Antibody Products

All products are available as matched antibody pairs (capture + detection), individual clones or enzyme conjugates. Click any product for full specifications.

Tumor Marker Cancer Application Formats Key Specs Details
PSA (Prostate-Specific Antigen) Prostate cancer screening, post-treatment monitoring CLIAELISALFA Detects total PSA; LoD <0.01 ng/mL; no non-specific protein interference View PSA Antibody Pair
AFP (Alpha-Fetoprotein) HCC surveillance, germ cell tumor monitoring CLIAELISA Wide dynamic range 1–1000 ng/mL; low albumin cross-reactivity View AFP Antibody Pair
CEA (Carcinoembryonic Antigen) Colorectal, lung, breast cancer monitoring CLIAELISA Specific to CEA; controlled cross-reactivity with NCA and BGP View CEA Antibody Pair
CYFRA21-1 (Cytokeratin 19 Fragment) NSCLC diagnosis, staging and therapy monitoring CLIAELISA Paired anti-CK19 mAbs; high sensitivity for squamous cell carcinoma View CYFRA21-1 Antibody Pair
ProGRP (Pro-Gastrin-Releasing Peptide) SCLC diagnosis, staging and treatment monitoring CLIAELISA Targets stable ProGRP precursor; high SCLC specificity vs. NSCLC View ProGRP Antibody Pair
CA19-9 (Carbohydrate Antigen 19-9) Pancreatic cancer diagnosis, biliary and colorectal cancer monitoring CLIAELISA Roche-equivalent pair (1116-NS-19-9 clone) + CanAg-equivalent pair (C192); humanized variants available View CA19-9 Antibody Pair
CA125 (Carbohydrate Antigen 125) Ovarian cancer screening, monitoring and recurrence detection CLIAELISA B-domain (S01-A107-1M/1H) + C-domain (S01-A107-2M) clones; humanized variant for HAMA reduction View CA125 Antibody Pair
CA15-3 (Carbohydrate Antigen 15-3) Breast cancer treatment monitoring and recurrence surveillance CLIAELISA 7 clones (S01-A108 series); Roche-equivalent pair (1M+3M) and CanAg-equivalent pair (4M+3M); humanized variants View CA15-3 Antibody Pair
CA72-4 (Carbohydrate Antigen 72-4) Gastric cancer diagnosis and monitoring; complementary to CEA CLIAELISA CC49 + B72.3 clones with humanized variants; Roche-equivalent pair (CC49 capture + B72.3-humanized detection) View CA72-4 Antibody Pair
CA50 (Carbohydrate Antigen 50) Pancreatic and GI cancer; complementary marker to CA19-9 CLIAELISA S01-A110-1M (mouse) + S01-A110-1H (humanized); validated vs CanAg C50 reference View CA50 Antibody Pair
View Full Antibody Catalog
10+
Oncology Marker Targets
<10%
Lot-to-Lot CV
30+
Countries Served
ISO
13485 Certified

3. Assay Formats Supported

Sekbio oncology antibody pairs are pre-validated for three IVD assay platforms, with platform-specific recommended working concentrations and calibration data.

CLIA

Chemiluminescent immunoassay pairs for automated clinical analyzer platforms. The primary format for PSA, AFP, CEA, CYFRA21-1 and ProGRP in hospital oncology labs requiring high throughput and low LoD.

ELISA

Sandwich ELISA-grade pairs for research and laboratory quantification. Biotin/streptavidin and HRP-conjugated detection antibodies available for all five oncology targets.

Lateral Flow Assay (LFA)

Colloidal gold conjugates for semi-quantitative POC cancer screening. Validated for PSA for point-of-care prostate cancer risk assessment in primary care settings.

Need a tumor marker not listed above? Sekbio continues to expand its oncology antibody portfolio. Contact us to discuss your requirements, or explore our custom antibody development platforms for novel tumor marker targets.

4. Why IVD Manufacturers Choose Sekbio for Oncology Antibodies

Oncology marker assays require extremely low limits of detection (LoD) — PSA must be detected at sub-ng/mL concentrations — combined with tight cross-reactivity control across structurally related proteins. Suboptimal antibody pair performance translates directly into missed cancers or unnecessary biopsies.

High-Sensitivity Formulation

Sekbio selects antibody clones with high binding affinity (Kd <1 nM) for oncology targets to achieve the sub-ng/mL LoD required in clinical cancer screening. Sensitivity data is provided for each pair.

Cross-Reactivity Controlled

CEA, AFP and PSA have structurally related family proteins that can cause false positives. Sekbio screens every pair against the full protein family and documents cross-reactivity in each product datasheet.

Industrial Scale, IVD Grade

Produced in CHO or hybridoma bioreactors at 100 mg to gram scale, with ISO 13485 batch documentation required for CE marking and FDA 510(k) regulatory submissions.

Tight Lot-to-Lot Consistency

Lot-to-lot CV <10% on key performance parameters means your assay QC stays in control across production batches — critical for multi-site clinical laboratory networks.

5. Frequently Asked Questions — Oncology Marker Antibodies

What are oncology marker antibody pairs for IVD?

Oncology marker antibody pairs are matched sets of capture and detection monoclonal antibodies used in sandwich immunoassays to quantify tumor-associated proteins in serum or blood. They are the core reagent components in CLIA, ELISA and LFA platforms used for cancer screening, diagnosis, staging and treatment monitoring — covering PSA, AFP, CEA, CYFRA21-1 and ProGRP.

Which oncology markers does Sekbio supply antibody pairs for?

Sekbio currently supplies antibody pairs for ten tumor marker targets: PSA (prostate cancer), AFP (hepatocellular carcinoma), CEA (colorectal, lung and breast cancer), CYFRA21-1 (NSCLC), ProGRP (SCLC), CA19-9 (pancreatic cancer), CA125 (ovarian cancer), CA15-3 (breast cancer), CA72-4 (gastric cancer) and CA50 (pancreatic and GI cancer). Contact Sekbio for the latest catalog and datasheet for each antibody pair.

What is CYFRA21-1 and why is it important in lung cancer IVD?

CYFRA21-1 is a soluble fragment of Cytokeratin 19 released into blood from epithelial tumor cells undergoing cell death. It is the most sensitive serum marker for NSCLC, particularly squamous cell carcinoma. Elevated CYFRA21-1 correlates with tumor stage and is used for diagnosis, staging and post-surgical recurrence monitoring. Sekbio's CYFRA21-1 antibody pair is validated for CLIA and ELISA formats.

How does ProGRP differ from NSE in small cell lung cancer diagnosis?

Both ProGRP and NSE (Neuron-Specific Enolase) are used for SCLC. ProGRP has higher sensitivity and specificity for SCLC than NSE — NSE can also be elevated in non-SCLC and non-cancer conditions, reducing its diagnostic specificity. ProGRP is stable in serum and less susceptible to sample hemolysis than NSE. For SCLC diagnosis and monitoring, ProGRP is the preferred marker in current clinical guidelines.

Are Sekbio oncology antibody pairs pre-validated on CLIA platforms?

Yes. Every oncology antibody pair is pre-validated on CLIA or ELISA platforms before catalog listing. Platform-specific calibration curve data, LoD, linearity range and lot-to-lot CV values are available alongside each product datasheet upon request.

How does Sekbio ensure batch-to-batch consistency for tumor marker antibodies?

Each batch undergoes SEC-HPLC purity testing, SDS-PAGE, binding activity ELISA and platform-specific functional assays. Lot-to-lot CV is maintained below 10%. All manufacturing is under ISO 13485 quality management, and full traceability documentation is provided for CE and FDA regulatory submissions.

Can Sekbio develop custom antibody pairs for oncology targets not in the catalog?

Yes. Sekbio offers end-to-end custom antibody development for novel tumor marker targets — from antigen design through hybridoma screening, pairing validation and stable cell line establishment. Typical delivery is 8–12 weeks. Explore our antibody development platforms or contact our team to discuss your target.

Ready to Build Your Oncology Assay?

Request a sample, download datasheets, or speak with a Sekbio antibody scientist about your tumor marker assay requirements.

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