Fujirebio Europe launches the automated Lumipulse® G SCC assay for the quantitative measurement of squamous cell carcinoma antigen

Product news

Fujirebio Europe announces the release of the Lumipulse G SCC assay for the automated quantitative measurement of squamous cell carcinoma (SCC) antigen in human serum or plasma. The Lumipulse G SCC is based on a two-step sandwich immunoassay method for the LUMIPULSE G System and uses fully automated unique cartridge CLEIA technology.

“Lung cancer is a significant global healthcare problem with not only a high number of incidents but also high mortality rates.” said Christiaan De Wilde, CEO of Fujirebio Europe. “At Fujirebio Europe we are proud of having led the way in oncology IVD testing solutions over the last many years. With the SCC biomarker both current and new Lumipulse G customers have access to a complete panel of automated testing solutions for lung disease management.”

The new Lumipulse G SCC assay is an important addition to the existing panel of Lumipulse G lung cancer biomarkers that already includes CEA, CYFRA and ProGRP. Along with the Lumipulse G Mesothelin assay for Mesothelioma testing and Lumipulse G KL-6 for Interstitial Lung Diseases (ILDs) the new SCC biomarker completes Fujirebio’s global automated lung disease management portfolio.

About Squamous cell carcinoma antigen (SCC Ag)

Squamous cell carcinoma antigen (SCC Ag) is a glycoprotein with a molecular weight of about 45 kDa belonging to the serine protease inhibitor superfamily.1 This protein was originally isolated from human squamous cell carcinoma tissue by Kato et al.2 Later, SCC Ag was confirmed to be composed of two highly homologous proteins, SCCA1 and SCCA2, and that both squamous cell carcinoma and normal tissues co-express SCCA1 and SCCA2.3-4 Lumipulse G SCC measures the total amount of SCCA1 and SCCA2 in human serum or plasma.

SCC Ag is a serological marker of squamous cell carcinomas of the uterine cervix, vulva, lung, head & neck, and oesophagus.5-9 In cervical squamous cell carcinoma patients, it was indicated that SCC Ag levels may reflect pathology and that measurement of SCC Ag may be useful as an adjunct in predicting prognosis, detecting recurrence and monitoring disease status.10-14 In other types of squamous cell carcinomas, it has been reported that similar behavior to cervical cancer are observed.15-24

It has been reported that SCC Ag levels are high in kidney disease and dermatitis, hemodialysis patients, and skin diseases such as psoriasis and eczema.25-27 False elevations of SCC Ag levels can occur in patients with these diseases.

About Fujirebio

Fujirebio is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 50 years accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.

Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.

For more information about Fujirebio please visit www.fujirebio.com.


  1. Suminami Y, et al. Squamous cell carcinoma antigen is a new member of the serine protease inhibitors. Biochem Biophys Res Commun, 181: 51-58, 1991.
  2. Kato H, Torigoe T. Radioimmunoassay for tumor antigen of human cervical squamous cell carcinoma. Cancer, 40: 1621-1628, 1977.
  3. Schneider SS, et al. A serine protease inhibitor locus at 18q21.3 contains a tandem duplication of the human squamous cell carcinoma antigen gene. Proc Natl Acad Sci USA, 92: 3147-3151, 1995.
  4. Cataltepe S, et al. Co-expression of the squamous cell carcinoma antigens 1 and 2 in normal adult human tissues and squamous cell carcinomas. J Histochem Cytochem, 48: 113-122, 2000.
  5. Kato H, et al. Tumor Antigen of Human Cervical Squamous Cell Carcinoma: correlation of circulating levels with disease progress. Cancer, 43: 585-590, 1979.
  6. van der Sijde R, et al. Significance of serum SCC antigen as a tumor marker in patients with squamous cell carcinoma of the vulva. Gynecol Oncol, 35: 227-232, 1989.
  7. Vassilakopoulos T, et al. Diagnostic and prognostic significance of squamous cell carcinoma antigen in non-small cell lung cancer. Lung Cancer, 32: 137-144, 2001.
  8. Snyderman CH, et al. A Reappraisal of the Squamous Cell Carcinoma Antigen as a Tumor Marker in Head and Neck Cancer. Arch Otolaryngol Head Neck Surg, 121: 1294-1297, 1995.
  9. Damle SR. Usefulness of Squamous Cell Carcinoma Antigen (SCC) in Carcinoma of Esophagus. Clin Chem, 34: 1299-1300, 1988.
  10. Kato H, et al. Value of Tumor-Antigen (TA-4) of Squamous Cell Carcinoma in Predicting the Extent of Cervical Cancer. Cancer, 50: 1294-1296, 1982.
  11. Kato H, et al. Prognostic Significance of the Tumor Antigen TA-4 in Squamous Cell Carcinoma of the Uterine Cervix. Am J Obstet Gynecol, 145: 350-354, 1983.
  12. Kato H, et al. Tumor- Antigen TA-4 in the Detection of Recurrence in Cervical Squamous Cell Carcinoma. Cancer, 54: 1544-1546, 1984.
  13. Maruo T, et al. Tumor-associated Antigen TA-4 in the Monitoring of the Effects of Therapy for Squamous Cell Carcinoma of the Uterine Cervix. Cancer, 56: 302-308, 1985.
  14. de Bruijn HW, et al. The Clinical Value of Squamous cell Carcinoma Antigen in Cancer of the Uterine Cervix. Tumor Biol, 19: 505-516, 1998.
  15. Yoshimura Y, et al. Squamous Cell Carcinoma Antigen in the Serum of Oromaxillary Cancer. Int J Oral Maxillofac Surg, 17: 49-53, 1988.
  16. Chen IH, et al. Using SCC antigen and CRP levels as prognostic biomarkers in recurrent oral cavity squamous cell carcinoma. PLoS One, 9: e103265, 2014.
  17. Yagi H, et al. Significance of Squamous Cell Carcinoma (SCC)-Related Antigens in Cutaneous SCC. Arch Dermatol, 123: 902-906, 1987.
  18. Petrelli N, et al. Squamous Cell Carcinoma Antigen as a Marker for Squamous Cell Carcinoma of the Anal Canal. J Clin Oncol, 6: 782-785, 1988.
  19. Yamanaka N, et al. Soluble Immune Complexes and Squamous Cell Carcinoma-Related Antigens in Patients with Head and Neck Cancer. Cancer, 62: 1932-1938, 1988.
  20. Mino N, et al. Availability of Tumor-Antigen 4 as a Marker of Squamous Cell Carcinoma of the Lung and Other Organs. Cancer, 62: 730-734, 1988.
  21. Eibling DE, et al. SCC-RIA in the Diagnosis of Squamous Cell Carcinoma of the Head and Neck. Laryngoscope, 99: 117-124, 1989.
  22. Sugimachi K, et al. Tumor antigen TA-4: an aid in detecting post-operative recurrences of esophageal carcinoma. Dis Markers, 5: 67-73, 1987.
  23. Hefler L, et al. Serum concentrations of squamous cell carcinoma antigen in patients with vulvar intraepithelial neoplasia and vulvar cancer. Int J Cancer, 84: 299-303, 1999.
  24. Henry RJ, et al. SCC Tumor Marker and Its Relationship to Clinical Stage in Squamous Cervical Cancer. Aust NZJ Obstet Gynaecol, 27:338-340, 1987.
  25. Torre GC. SCC antigen in malignant and nonmalignant squamous lesions. Tumor Biol, 19: 517-526, 1998.
  26. Molina R, et al. SCC antigen measured in malignant and nonmalignant diseases. Clin Chem, 36: 251-254, 1990.
  27. Duk JM, et al. Elevated levels of squamous cell carcinoma antigen in patients with benign disease of the skin. Cancer, 64: 1652-1656, 1989.