p63 + CK5

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The p63 + CK5 antibody multiplex stain has been especially designed for squamous cell carcinomas, particularly those derived in lung cancer. In-house studies has shown greater than 80% of squamous cell carcinoma of the lung were positive and other studies have shown that the combination of p63 and CK5 was useful for differentiating adenocarcinoma from squamous cell carcinoma with 100% specificity and 82% sensitivity, 89% specificity and 79% sensitivity, respectively. Studies have also shown that TTF-1 and Napsin A are highly specific and sensitive for lung adenocarcinomas. A critical assessment is essential for correct diagnosis because patients with squamous carcinoma (SqCC) cannot receive Avastin therapy due to a 30% mortality rate as a result of fatal hemoptysis (hemorrhaging). Therefore when used in a panel with TTF-1 + Napsin A, this unique antibody cocktail of p63 + CK5 should prove useful for immunohistochemical analysis of poorly differentiated lung adenocarcinomas versus squamous cell carcinomas in formalin-fixed paraffin-embedded tissues.

Intended Use

IVD

Species Reactivity

Human

Source

Mouse Monoclonal, Rabbit Monoclonal

Clone

4A4 EP42

Isotype

IgG2a / Kappa + IgG

Antigen

p63 CK5

Localization

Nuclear Cell Surface/Cytoplasmic

Positive Control

Lung squamous cell carcinoma

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Download RUO Data Sheet for International
Download SDS Sheet

Regulatory Notice: Biocare’s IVD-labeled products comply with US-FDA and European IVDD regulation. Other regions may have additional requirements for such labeling, please contact your local distributor.

1. Downey P, Cummins R, Moran M, et al: If it’s not CK5/6 positive, TTF-1 negative it’s not a squamous cell carcinoma of lung. Apmis 116:526–529, 2008.
2. Kargi A, Gurel D, Tuna B: The diagnostic value of TTF-1, CK 5/6, and p63 immunostaining in classification of lung carcinomas. Appl Immunohistochem Mol Morphol 15:415–420, 2007.
3. Khayyata S, Yun S, Pasha T, et al: Value of P63 and CK5/6 in distinguishing squamous cell carcinoma from adenocarcinoma in lung fine-needle aspiration specimens. Diagn Cytopathol 37:178–183, 2009.
4. Rossi G, Papotti M, Barbareschi M, et al: Morphology and a limited number of immunohistochemical markers may efficiently subtype non–small-cell lung cancer. J Clin Oncol 27:e141–e142, 2009.
5. Bishop JA, Sharma R, IIIei PB. Napsin A and TTF-1 expression in carcinomas of the lung, breast, pancreas, colon, kidney, thyroid, and malignant mesotheilioma. Human Pathol. 2010 Jan;41(1):20-5. Epub 2009 Sept 8.
6. Center for Disease Control Manual. Guide: Safety Management, NO. CDC-22, Atlanta, GA. April 30, 1976 “Decontamination of Laboratory Sink Drains to Remove Azide Salts.”
7. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory workers from occupationally Acquired Infections; Approved guideline-Third Edition CLSI document M29-A3 Wayne, PA 2005.

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