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Roche Elecsys Anti-p53 Test for Cancer Diagnosis Earns CE Mark

NEW YORK – Roche announced on Wednesday that its Elecsys Anti-p53 immunoassay for the quantitative detection of anti-p53 autoantibodies has received CE marking.

The assay is now available in markets that accept the designation.

The electrochemiluminescence test, which runs on Roche's line of Cobas e analyzers, can be used in conjunction with other diagnostic tests to help clinicians diagnose throat cancer, bowel cancer, and breast cancer, Roche said in a statement. It could also be used to monitor cancer cell remnants in a patient's body after treatment. 

When active, the p53 protein helps regulate the processes that stop tumors from developing. A mutation of the protein is present in half of solid tumor cancers and "is the most common genetic change identified so far in human cancers," Roche said. Some mutations of p53 can result in a buildup of the protein, resulting in the formation of anti-p53 autoantibodies. The mutation causes p53's tumor-suppressing function to switch to a tumor-promoting function. 

The early appearance of these antibodies could help detect malignant changes indicating cancer. The test can also help clinicians determine which patients require less invasive treatment, Basel, Switzerland-based Roche said.