SCC Monoclonal Antibody for Squamous Cell Carcinoma Antigen CLIA IVD Development
SCC Antigen (Squamous Cell Carcinoma Antigen) is a ~48 kDa glycoprotein belonging to the serine protease inhibitor (serpin) superfamily. It is encoded by two closely related genes: SCCA1 (SERPINB3) and SCCA2 (SERPINB4), located on chromosome 18q21.3. Both proteins share approximately 92% amino acid sequence identity and are predominantly expressed in the squamous epithelium of the skin, cervix, lung, and esophagus. In malignant squamous epithelium, SCCA expression is markedly upregulated, and elevated serum SCC antigen serves as a well-established tumor marker in clinical oncology.
Clinically, serum SCC antigen is most widely used for cervical cancer monitoring: it correlates with tumor stage, response to therapy, and early detection of recurrence. The normal serum reference value is <1.5 ng/mL; levels above this threshold indicate potential squamous cell malignancy. SCC is also elevated in lung squamous cell carcinoma (but not in adenocarcinoma or small-cell lung cancer), esophageal SCC, and head-and-neck squamous cell carcinomas, making it a clinically specific marker for squamous histology across multiple cancer types. Serial SCC measurement is recommended for post-treatment surveillance of cervical cancer (FIGO stages IB–IVA) and for monitoring chemotherapy or radiotherapy response.
For IVD immunoassay development, SCC quantification by CLIA sandwich immunoassay is the standard clinical platform. A matched antibody pair recognizing two non-overlapping epitopes on the SCC antigen molecule is essential. Sekbio supplies S01-SCC-1M (capture) and S01-SCC-2M (detection), a validated mouse anti-human SCC monoclonal antibody pair for CLIA IVD development, covering the clinically relevant SCC range from normal (<1.5 ng/mL) to markedly elevated (>10 ng/mL) in advanced squamous cell carcinoma.
Two anti-SCC monoclonal antibodies for complete CLIA sandwich immunoassay development targeting squamous cell carcinoma antigen.
| Catalog No. | Product Name | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S01-SCC-1M | Mouse Anti-Human SCC Monoclonal Antibody | IgG1 | >90% SEC-HPLC | Capture — CLIA | +2°C to +8°C |
| S01-SCC-2M | Mouse Anti-Human SCC Monoclonal Antibody | IgG1 | >90% SEC-HPLC | Detection — CLIA | +2°C to +8°C |
All products supplied in 20 mM PB, 150 mM NaCl, pH 7.4. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing.
Engineered for the sensitivity and specificity required in clinical squamous cell carcinoma diagnosis, treatment monitoring, and recurrence surveillance.
Sekbio provides S01-SCC-1M (capture) and S01-SCC-2M (detection) as a validated matched pair targeting distinct, non-overlapping epitopes on the ~48 kDa SCC antigen. The capture/detection pair is optimized for CLIA sandwich immunoassay format, enabling high-sensitivity SCC quantification across the clinical range from normal (<1.5 ng/mL) to markedly elevated values in advanced cervical and lung squamous cell carcinoma.
Both S01-SCC-1M and S01-SCC-2M are validated for CLIA (chemiluminescence immunoassay) sandwich format, the dominant platform for SCC antigen quantification in hospital laboratory oncology panels. The validated pair supports direct integration into automated CLIA analyzer workflows, enabling high-throughput SCC tumor marker testing alongside complementary markers such as CEA, AFP, and CA125.
Manufactured under ISO 13485 quality management system with inter-batch CV <10%. Each production lot undergoes appearance, purity (SEC-HPLC), and bioreactivity QC with full Certificate of Analysis. Consistent inter-lot performance is critical for SCC tumor marker monitoring applications, where serial patient measurements require comparable calibration across antibody lots.
Purity >90% by SEC-HPLC with low aggregation minimises non-specific binding in CLIA microparticle assay formats. Reduced background noise is essential for SCC tumor marker assays that must accurately discriminate between normal (<1.5 ng/mL) and borderline-elevated samples — a clinically critical distinction for early-stage cervical cancer recurrence detection and post-treatment follow-up.
SCC is a key component of comprehensive oncology tumor marker CLIA panels. Sekbio's SCC antibody pair can be co-developed with other Sekbio tumor marker antibodies (AFP, CEA, CA125, CA19-9, NSE, CYFRA 21-1) on a single CLIA platform. This enables IVD manufacturers to source a complete tumor marker antibody portfolio from a single ISO 13485-certified supplier, simplifying supply chain management and regulatory documentation.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D evaluation; gram-scale production supply for OEM CLIA kit manufacturing. Full regulatory documentation package available for CE marking, NMPA, and FDA 510(k) submissions. SCC CLIA kits are in high demand in European, North American, Korean, and Japanese IVD markets. Visit our Platforms page for antibody development services.
SCC antibody pair validated for squamous cell carcinoma diagnosis, treatment monitoring, and recurrence detection kit development.
SCC antigen is the primary serum tumor marker for squamous cell cervical cancer, correlating with FIGO stage, tumor volume, parametrial invasion, and lymph node metastasis. Serum SCC >1.5 ng/mL is indicative of squamous cell cervical carcinoma, with levels increasing proportionally with disease stage. Post-treatment serial SCC measurement is guideline-recommended for early recurrence detection — rising SCC often precedes clinical or radiological evidence of recurrence by weeks to months. Sekbio's S01-SCC-1M/2M pair supports CLIA kit development for cervical cancer screening and follow-up programs across Europe, Asia, and North America.
SCC antigen is selectively elevated in lung squamous cell carcinoma (LSCC) — the second most common histological subtype of non-small cell lung cancer (NSCLC). Unlike CYFRA 21-1 (which is elevated across NSCLC subtypes), SCC specificity for squamous histology makes it complementary for histological subtype differentiation. Elevated SCC combined with CEA and CYFRA 21-1 improves diagnostic sensitivity and specificity for NSCLC. SCC monitoring in LSCC enables assessment of treatment response to platinum-based chemotherapy and immunotherapy regimens. Sekbio's SCC CLIA antibody pair supports multi-marker lung cancer panel development.
SCC antigen is elevated in esophageal squamous cell carcinoma (ESCC) and squamous cell carcinomas of the head-and-neck (HNSCC), including oral cavity, pharynx, and larynx cancers. ESCC accounts for the majority of esophageal cancers in Asia and Africa, representing a large and underserved IVD market opportunity. SCC serial monitoring supports staging, resectability assessment, and post-operative recurrence surveillance in ESCC and HNSCC. A CLIA SCC assay based on Sekbio's antibody pair enables IVD manufacturers to address the growing demand for gastrointestinal and head-and-neck cancer tumor marker testing in Asian and African markets.
SCC is a standard component of hospital oncology CLIA panels alongside AFP, CEA, CA125, CA19-9, PSA, and CYFRA 21-1. IVD manufacturers developing multi-analyte tumor marker CLIA systems can integrate Sekbio's S01-SCC-1M/S01-SCC-2M antibody pair for SCC quantification. ISO 13485-certified batch data, Certificate of Analysis, and regulatory documentation are available to support CE marking, NMPA, and FDA 510(k) submissions. Contact our team for OEM supply agreements. Visit our Products page for complete antibody raw material catalog.
Technical and commercial questions from IVD R&D engineers and procurement teams developing SCC tumor marker CLIA assays.
SCC Antigen is a ~48 kDa glycoprotein (serpin family, encoded by SCCA1/SERPINB3 and SCCA2/SERPINB4) overexpressed in squamous cell carcinomas of the cervix, lung, esophagus, and head-and-neck. Normal serum SCC is <1.5 ng/mL; elevated levels indicate squamous cell malignancy. SCC is guideline-recommended for cervical cancer staging (FIGO IB–IVA), treatment response assessment, and post-treatment recurrence surveillance. It is also used in lung SCC differential diagnosis and esophageal SCC monitoring. Its specificity for squamous histology makes it complementary to adenocarcinoma markers such as CEA and CA125.
Sekbio supplies: S01-SCC-1M (mouse anti-human SCC monoclonal antibody, IgG1, for CLIA capture) and S01-SCC-2M (mouse anti-human SCC monoclonal antibody, IgG1, for CLIA detection). Both are affinity-purified, purity >90% by SEC-HPLC, supplied in 20 mM PB, 150 mM NaCl, pH 7.4. Certificate of Analysis provided with every lot. MOQ 1 mg.
S01-SCC-1M and S01-SCC-2M are validated for CLIA (chemiluminescence immunoassay) sandwich format — the dominant platform for SCC quantification in hospital oncology laboratories. The pair supports direct integration into automated CLIA analyzers. For other platform requirements (ELISA, LFA), contact info@sekbio.com to discuss technical feasibility and custom validation support.
Both SCC antibodies are purified with purity >90% by SEC-HPLC. Manufactured under ISO 13485 QMS with inter-batch CV <10%. Each production lot undergoes appearance inspection, SEC-HPLC purity analysis, and functional bioreactivity QC in sandwich CLIA format. A Certificate of Analysis with lot-specific QC data is provided with every shipment, supporting regulatory dossier requirements for CE-marked and NMPA-registered SCC CLIA kits.
MOQ is 1 mg for R&D evaluation; OEM quantities from 10 mg to gram scale available for production-scale CLIA kit manufacturing. Storage: +2°C to +8°C short-term (≤1 month); −20°C long-term. Avoid repeated freeze/thaw cycles. All supplied in 20 mM PB, 150 mM NaCl, pH 7.4. Shelf life: 3 years from manufacturing date.
Yes. Sekbio supplies SCC antibodies at gram scale under ISO 13485 QMS for OEM CLIA kit manufacturers globally. Full regulatory documentation including Certificate of Analysis, manufacturing records, and material safety data is available to support CE marking (EU IVDR), NMPA registration, and FDA 510(k) submissions. Contact info@sekbio.com to discuss OEM supply agreements, technical support, and custom documentation packages. Visit our Platforms page for antibody development and production services.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply with our team.