Elecsys® SCC

An important part of Roche’s portfolio in tumor markers for managing patients with squamous cell cancers

Elecsys SCC
An important part of Roche’s portfolio in tumor markers for managing patients with squamous cell cancers

The SCC assay is used as an aid in the management of patients with squamous cell carcinoma in conjunction with other methods that align to the standard ­clinical management guidelines.

SCCA levels can be elevated in squamous cell cancers and it has been ­reported that more advanced cancer stages are associated with higher SCCA levels ­especially in lung and cervical cancer.1,2,7 It was reported that measurement of the ­antigen, in serial determinations, aids in the assessment of disease recurrence, residual disease following treatment, and response to therapy.3,4,7

SCC antigen in different types of squamous cell cancers:

General clinical relevance of SCCA: 
SCCA has been studied in squamous cell malignancies including lung, uterine cervix, esophagus, head & neck, anal canal and skin.12,13,14,15 The more advanced cancer stages are associated with higher SCCA levels especially in lung- and cervical cancer and it was reported that measurement of the antigen, in serial determinations, aids in the assessment of disease recurrence, residual disease following treatment, and response to therapy.16,17

SCCA in lung cancer:
SCCA has been reported as a biomarker for non-small cell lung cancer (NSCLC), mainly of the squamous cell carcinoma type, provided that patients with renal failure are excluded.25 SCC in lung is closely correlated with a history of tobacco smoking, more than other types of lung cancer.26 Utility of SCCA in lung cancer has also been reported as it indicates disease recurrence and residual disease following treatment and response to therapy'

SCCA in cervical cancer:
The most common histology in cervical cancer is SCC, with SCCA being the biomarker of choice for this histology. Serum levels of SCCA have been found to correlate with tumor stage, tumor size, residual tumor after treatment, recurrent or progressive disease, and survival in patients with squamous cell cervical cancer.29,30 SCCA has been recognized as the marker of choice for the follow-up of cervical cancer according to the European Group of Tumor Markers guidelines. Especially the value in predicting prognosis, monitoring31 and pretreatment identification of patients at high risk for lymph node metastases in squamous cell cervical cancer has been described in literature.32

SCCA in head & neck cancer:
Head & neck cancer refers to a group of biologically similar cancers that can occur for example in the lip, oral and nasal cavity, pharynx, and larynx. In patients with primary tumors, SCCA serum levels were related to nodal involvement with significantly higher levels in node-positive patients. Multivariate analyses showed that SCCA is a significant independent predictor of disease-free survival and pretreatment levels are an independent prognostic indicator in patients with head and neck malignancies.34

 

Benefits

 

  • SCC antigen as biomarker for cervical cancer is part of Roche tool pannel for management of patients with gynecological malignancies (i.e. CA 125, HE4, CA 15-3, HPV, CINtec® PLUS Cytology)
  • Precision assay for accurate and sustainable results for patient monitoring
  • Lung cancer biomarkers available on a single automated platform - Elecsys® CEA, Elecsys® CYFRA 21-1, Elecsys® NSE, Elecsys® ProGRP and Elecsys® SCC
  • 16 weeks on-board stability
  • 18 min turn around time

Product specifications1,2

  • System

    cobas e 411 analyser, cobas e 601/cobas e 602 modules
    cobas e 801 analytical unit, cobas e 402 analytical unit  

  • On-board stability

    16 weeks

  • Assay time

    18 min

  • Sample material

    Serum collected using standard sampling tubes or tubes containing separating gel. Li‑heparin, K2‑EDTA and K3‑EDTA plasma.

  • Test principle

    Antigen sandwich assay

  • Calibration

    2-point

  • Sample volume

    15 μL cobas e 411, cobas e 601 cobas e 602
    9 μL cobas e 801, cobas e 402

     

  • Measuring range

    0.1– 70 ng/mL

  • LoQ

    0.6 ng/mL cobas e 411, cobas e 601 cobas e 602
    0.2 ng/ml cobas e 801, cobas e 402

     

     

     

     

     

  • Limit of detection

    0.2 ng/ml cobas e 411, cobas e 601, cobas e 602 
    0.2 ng/ml cobas e 402, cobas e 801

  • Intermediate precision in positive samples*

    cobas e 411: 2.0 - 4.8 % CV
    cobas e 601 & 602 : 1.8-4.2 % CV
    cobas e 801, cobas e 402 analytical units: 1.2-4-2 % CV

  • Repeatability in positive samples

    cobas e 411 CV 1.1 - 3.8 % 
    cobas e 601, cobas e 602 CV 1.4 - 3.9 %  
    cobas e 402, cobas e 801 CV 1.1 - 3.8 % CV

  • Standardization

    Abbott Architect

  • Detection of SCC antigen 1 and 2

    Yes

* Human samples only

References

 

  1. Elecsys® SCC Method Sheet for material 0712697219 for cobas e 411, cobas e 601 & cobas e 602
  2. Elecsys® SCC Method Sheet for material 0702825319 for cobas e 801 & cobas e 402
  3. Einarsson, R. (2005). Squamous Cell Carcinoma Antigen (SCCA) Isomers- Markers for squamous cell carcinoma. Adv. Clin. Exp. Med.; 14: 643-648. 
  4. Henry, R.J., Dodd, J.K., Tyler, J.P., and Houghton, C.R. (1987). SCC Tumor Marker and Its Relationship to Clinical Stage in Squamous Cervical Cancer. Aust. NZl. Obstet. Gynaecol.; 27: 338-340. 
  5. Kenter, G., Bonfrer, J.M.G. and Heintz, A.P.M. (1987). Pretreatment Tumor-Antigen TA-4 in Serum of Patients With Squamous Cell Carcinoma of the Uterine Cervix. Br. J. Cancer; 56: 157-158. 
  6. Barak, V., Holdenrieder, S., Nisman, B., et al. (2009/2010). Relevance of circulating biomarkers for the therapy monitoring and follow-up investigations in patients with non-small cell lung cancer. Cancer Biomarkers; 6: 191-196. 
  7. Kenfield, S.A., Wei, E.K., Stampfer, M.J., Rosner, B.A., Colditz, G.A. (2008). Comparison of aspects of smoking among the four histological types of lung cancer. Tobacco Control; 17: 198–204. 
  8. Molina, R., Auge, J.A., Escudero, J.M., et al. (2008). Mucins CA 125, CA 19.9, CA 15.3 and TAG-72.4 as Tumor Markers in Patients with Lung Cancer: Comparison with CYFRA 21-1, CEA, SCC and NSE. Tumor. Biol.; 29: 371-380. 
  9. Lozza, L., Merola, M., Fontanelli, R., et al. (1997). Cancer of the uterine cervix: clinical value of squamous cell carcinoma antigen (SCC) measurements. Anticancer Research; 17: 525-530. 
  10. Kato, H. et al. (1983). Prognostic significance of the tumor antigen T4-A in squamous cell carcinoma of the uterine cervix. Am. J. Obstet. Gynecol.; 145: 350-354.