p16 INK4a [BC42] IVD


p16 antibody: p16 INK4a is a tumor suppressor protein involved in the pathogenesis of a variety of malignancies. It is a specific inhibitor of cdk4/cdk6. Recent analyses of the p16INK4a gene revealed homozygous deletions, nonsense, missense, or frameshift mutations in several human cancers (1). Although the frequency of p16 INK4a abnormalities is higher in tumor-derived cell lines than in unselected primary tumors, significant subsets of clinical cases with aberrant p16 INK4a gene have been reported among melanomas, gliomas, esophageal, pancreatic, lung, and urinary bladder carcinomas (2). p16 immunoreactivity in paraffin-embedded tissues has also been shown to be an independent predictor in minimally invasive urothelial bladder cancer; a prognostic factor in non-small cell lung carcinoma; and has been shown to predict a positive response to chemoradiotherapy in Stage IV head and neck squamous cell carcinoma (3-6).

p16 INK4a [BC42] is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of p16 INK4a protein by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.




1. LaPak KM, Burd CE. The molecular balancing act of p16(INK4a) in cancer and aging. Mol Cancer Res. 2014 Feb; 12(2):167-83.
2. Mahajan A. Practical issues in the application of p16 immunohistochemistry in diagnostic pathology. Hum Pathol. 2016 May; 51:64-74.
3. Tong J, et al. Expression of p16 in non-small cell lung cancer and its prognostic significance: A meta-analysis of published literatures. Lung Cancer. 2011 Nov; 74(2):155-63.
4. Chen YJ, et al. High p16 expression predicts a positive response to chemoradiotherapy in stage IVa/b head and neck squamous cell carcinoma. Asian Pac J Cancer Prev. 2011; 12(3):649-55.
5. Snow AN, Laudadio J. Human papillomavirus detection in head and neck squamous cell carcinomas. Adv Anat Pathol. 2010 Nov; 17(6):394- 403.
6. Buza N, et al. Inverse p16 and p63 expression in small cell carcinoma and high-grade urothelial cell carcinoma of the urinary bladder. Int J Surg Pathol. 2010 Apr; 18 (2):94-102.
7. 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.”
8. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Fourth Edition CLSI document M29-A4 Wayne, PA 2014.


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