The anti-p53 assay is used to aid in the diagnosis of esophageal cancer, colorectal cancer and breast cancer in conjunction with other tests.1,2
Mutation of p53 is present in half of the solid tumors.3 It is the most common genetic change identified so far in human cancers.4 When a mutation in p53 or other mutations lead to an accumulation of p53 in the cytoplasm, proteolytic fragments thereof may be presented on the cell surface or otherwise released, resulting in the formation of anti-p53 autoantibodies.3
Early appearance of anti-p53 antibodies during tumor development may have potential for detecting malignant transformation, especially in patients with pre-neoplastic disease.5
Anti-p53 antibodies have a very high specificity of 96% to up to near 100%3,5 but a low sensitivity for cancer.
The registrational data of Elecsys® Anti-p53 assay as aid in diagnosis of esophageal cancer, colorectal cancer and breast cancer in conjunction with other tests have been provided by Roche Multi Centre Evaluation study for clinical performance.
The Sample Collection study was performed in an observational case-control study design with prospective and retrospective samples with a total of 676 patients and 400 controls.10