Core Assays

Core Assays

Roche Diagnostics offers a menu of more than 250 assays in key disease states, providing consistent and high-quality performance to aid in accurate diagnosis. From screening and diagnosis to therapy prediction and monitoring, we empower clinicians with the information they need to make confident, timely patient care decisions. 

Cytokeratin (OSCAR) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of a broad spectrum of cytokeratin proteins in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) testing on BenchMark IHC/ISH instruments.

This antibody stains cytokeratins present in normal and malignant epithelial tissues, making it useful for aiding in the identification of epithelial malignancies.1-4

Benefits of Cytokeratin (OSCAR):

• In vitro diagnostic; Ready to use

• Decreased cross-reactivity with gliomas vs. AE1/AE32

 • Reactive with cytokeratin 18, which can identify tumors missed by AE1/AE3 (e.g. hepatocellular carcinoma)2

References

1 Galera P, et al. Diagnosis of Metaplastic Breast Carcinoma: Keratin OSCAR Versus Other Cytokeratins. Appl Immunohistochem Mol Morphol. 2016 Oct;24(9):622-626

2 Ordóñez NG. Broad-spectrum immunohistochemical epithelial markers: a review. Hum Pathol. 2013 Jul;44(7):1195-215

3 Goddard MJ, et al. Comparison of commercially available cytokeratin antibodies in normal and neoplastic adult epithelial and non-epithelial tissues. J Clin Pathol. 1991 Aug;44(8):660-3.

4 Chu PG, et al. Keratin expression in human tissues and neoplasms. Histopathology. 2002 May;40(5):403-39


The FGFR2b-specific mouse monoclonal antibody (FPR2-D) detects FGFR2 expression in gastric cancer tissues with FGFR2b protein overexpression.1 The VENTANA FGFR2b (FPR2-D)Mouse Monoclonal Antibody is intended for laboratory use in the qualitative immunohistochemical detection of FGFR2b by light microscopy in sections of formalin-fixed, paraffin-embedded tissues stained on a BenchMark IHC/ISH instrument.

References

1 Deshpande AM, Palencia S, Bellovin DI, et al. Abstract 2845: Expression of FGFR2b in gastric cancer as measured by immunohistochemistry with a highly specific monoclonal antibody.

Cancer Research. 2014;74 (19 Supplement):2845-2845. https://www.researchgate.net/publication/276504277_Abstract_2845_Expression_of_FGFR2b_in_gastric_cancer_as_measured_by_

immunohistochemistry_with_a_highly_specific_monoclonal_antibody. Accessed on January 21, 2024.


Immunohistochemical detection of SF-1 may provide value for identifying

sex-cord stromal tumors - including Leydig cell, Sertoli cell and granulosa cell neoplasms - from other tumors.1,2 In addition, SF-1 testing may have utility in distinguishing between primary adrenal cortical lesions and their histologic mimics such as renal cell carcinoma.3

SF-1 (EP434) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of the steroidogenic factor-1 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry on BenchMark IHC/ISH instruments.

Benefits of SF-1 (EP434):

• In vitro diagnostic; Ready to use

• Identification and differentiation of sex-cord stromal tumors (Leydig cell, Sertoli cell and granulosa cell neoplasms) from other tumors.1,2

• Useful in distinguishing between primary adrenal cortical lesions and their histologic mimics such as renal cell carcinoma.3

References

1 Sangoi AR et al. Evaluation of SF-1 Expression in Testicular Germ Cell Tumors: A Tissue Microarray Study of 127 cases. Applied Immunohistochemistry and Molecular Morphology 2013 21(4): 318-321

2 Zhao, C et al. Identification of the Most Sensitive and Robust Immunohistochemical Markers in Different Categories of Ovarian Sex Cord-stromal Tumors. American Journal of Surgical Pathology 2009 33(3): 354-366

3 Sangoi, AR et al. Immunohistochemical distinction of primary adrenal cortical lesions from metastatic clear cell renal cell carcinoma: a study of 248 cases. American Journal of Surgical Pathology 2011 35(5): 678-686


CD8 is a transmembrane glycoprotein expressed by cytotoxic T-cells and at low levels in NK-cells and a subpopulation of bone marrow cells1-3. A cytotoxic T-cell marker, CD8 positive T-cells are mainly involved in cytotoxic immunoreactions4. CD8 is absent on immature T-cells and expressed in later stages of T-cell development as the cell matures into a cytotoxic T-cell5-6. CD8 (SP239) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the qualitative immunohistochemical detection of CD8 by light microscopy in sections of formalin-fixed, paraffin-embedded tissue stained on a BenchMark IHC/ISH instrument.

Benefits of CD8 (SP239) antibody:

• In vitro diagnostic; Ready to use

• Recombinant technology offering consistent and reproducible results

• In a comparison antibody test by NordiQC, CD8 (SP239) antibody scored “optimal” and equivalent to the NordiQC reference antibody7

• A cornerstone product in the Roche hematopathology tissue menu, a comprehensive offering of over 70 robust IHC and ISH assays supported by innovative detection, automation and workflow solutions

References

1 Dabbs DJ. Diagnostic Immunohistochemistry Theranostic and Genomic Applications, 5th edition. Vol 5. Amsterdam, Netherlands: Elsevier; 2019.

2 Higgins RA, Blankenship JE, Kinney MC. Application of immunohistochemistry in the diagnosis of non-Hodgkin and Hodgkin lymphoma. Arch Pathol Lab Med. 2008; 132(3):441-461.

3 Naeim F. Principles of Immunophenotyping. In Naeim F, Rao PN, Grody WW, eds. Hematopathology: Morphology, Immunophenotype, Cytogenetics, and Molecular Approaches. Cambridge, MA: Academic Press; 2009.

4 https://www.nordiqc.org/epitope.php?id=22. Accessed 19 April 2023.

5 Rich R, Fleisher T, Shearer W, Frew A, Weyand C. Clinical Immunology Principles and Practice, 5th edition. Vol 5. Amsterdam, Netherlands: Elsevier, 2018.

6 Swerdlow SH, Campo E, Harris NL, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues, 4th edition. Vol 4. Lyon, France: International Agency for Research on Cancer; 2008.

7 Data on file

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