On-line video tutorial demonstrates diagnosis of HER-2/neu oncoprotein levels in revolutionary breast cancer treatment
Bayer has launched an on-line tutorial about a fundamental improvement in diagnosing and treating breast cancer.
The audio-visual tutorial, of about ten minutes, explains with great clarity the significance of its HER-2/neu immunoassay test. Entitled 'The clinical utility of monitoring serum HER-2/neu oncoprotein levels in metastatic breast cancer patients', Walter Carney's tutorial explains how the automated HER-2/neu immunoassay test is the only serum test available for testing HER-2/neu status.
It is the only test cleared by the US Food and Drug Administration (FDA) for follow-up testing and monitoring therapy in metastatic breast cancer (MBC), reports Bayer.
Dr Carney explains how using this serum test overcomes the impracticality of continuously taking biopsies for testing purposes and has the potential to fill in a recognised diagnostic 'gap' whereby patients whose original tissue biopsies were HER-2/neu negative subsequently go on to over-express the oncogene into the serum of the extracellular domain.
The HER-2/neu oncoprotein participates in converting normal cells to cancer cells.
Monitoring its status can guide therapy in MBC patients.
Critically, MBC patients who have HER-2/neu positive tumours are the only eligible candidates for HER-2/neu therapy; a positive status is not a guarantee that the patient will respond but can be used to determine whether a patient will benefit from Herceptin therapy, a drug which 'switches off' the growth factor driving development of the tumour.
Herceptin has the distinction of being one of few drugs in the world whose prescription is dependent on a diagnostic test.
The test overcomes the disadvantages of the traditional histological techniques currently used to assess HER-2/neu status: immunohistochemistry (IHC), and fluorescence in situ hybridisation (Fish).
IHC is used to detect HER-2/neu protein levels in biopsy samples.
Greater accuracy may be achieved by using the semi-quantitative Fish method, which detects the amount of genetic material present in the tissue but requires a high degree of technical expertise.
The prognosis for patients whose tumours are HER-2/neu positive is poor unless they are treated with Herceptin.
Dr Carney describes how monitoring the circulating HER-2/neu extracellular domain provides a tool for assessing prognosis, for predicting response to therapy, and for earlier detection of disease progression and timely intervention with appropriate therapy.
Breast cancer often metastasises into other cancers in the body via the lymph nodes.
"HER-2/neu is an excellent model for the future of individualised and personalised medicine", concludes Dr Carney.
The HER-2/neu test is now available from Bayer Diagnostics for use on the high-throughput Advia Centaur immunoassay system.
It provides a convenient, rapid and highly accurate alternative to existing methods, says the company.
