Currently available in all markets accepting the CE mark, the assay can be used for in vitro quantitative detection of anti-p53 antibodies in human serum and plasma. These antibodies wrongly target a person’s own tissues, leading to the development of solid tumours.
The high precision immunoassay has a low turn-around time for testing and utilises the well-established electrochemiluminescence immunoassay ECLIA technology.
Roche noted that the assay is intended for use on cobas e immunoassay analysers.
Roche diagnostics CEO Thomas Schinecker said: “The addition of our Elecsys Anti-p53 immunoassay will help clinicians to quickly and reliably diagnose several prevalent cancers and might assist in leading to a better prognosis for many patients.
“Beyond breakthrough cancer medicines, Roche also offers a growing number of testing solutions to help physicians diagnose and treat people with cancer.”
Anti-p53 antibodies’ appearance during the early developmental stages of tumours could potentially make it easier to identify malignant changes.
When used alongside other diagnostic tests, the immunoassay can diagnose certain cancers at an earlier stage, which could potentially improve patient outcomes.
Furthermore, analysing the presence of anti-p53 antibodies could be used for monitoring cancerous cell remnants still present in the body after treatment.
The Elecsys Anti-p53 test could also help in deciding which patients would need less invasive procedures as part of their cancer treatment.
Last month, the German Federal Institute for Drugs and Medical Devices (BfArM) granted special approval to Roche’s SARS-CoV-2 Rapid Antigen Test, which uses a simple nasal swab for patient self-testing in the country.