Traditional tissue HER-2 testing provides information on the HER-2 status of primary breast cancer, but not recurrent metastatic disease. Thousands of women each year are diagnosed with metastatic breast cancer. The Serum HER-2/neu Test from Siemens is the only FDA-cleared method for monitoring changes in HER-2 status, which may help guide therapeutic
decisions.1-3
In HER-2 positive breast cancer, the cancer cells have an abnormal number of HER-2/neu genes per cell, which leads to abnormally high levels of certain cancer-promoting proteins called oncoproteins. This causes the cancer cells to grow and divide quickly. HER-2 positivity has been shown to be an indicator of poor prognosis, higher probability of recurrence, and decreased overall survival. Traditional HER-2/neu testing has been generally limited to tissue from primary breast cancer and does not provide information regarding the HER-2/neu status at the time of recurrent metastatic breast cancer. It is used as a predictor of response to therapy but cannot monitor the real-time responses patients will go through during the clinical course of disease. With the Serum HER-2/neu test from Siemens, therapy personalization has entered its next phase—the real-time assessment of HER-2 status for all metastatic breast cancer patients.
Serum HER-2/neu from Siemens Healthcare Diagnostics is the first FDA-cleared blood test for measuring circulating HER-2/neu in patients with metastatic disease. Now oncologists can follow disease progression with a simple non-invasive procedure as part of a patient’s routine blood work-up. Decreasing levels of Serum HER-2/neu (<15 ng/ml) may indicate treatment response and disease stability. Increasing levels of Serum HER-2/neu (>15 ng/ml) may indicate disease progression.1-3
According to Jean Pierre Lotz, Chief Medical Oncologist of the University Hospital in Paris, his "first experiences with measuring Serum HER-2/neu for metastatic breast cancer showed that after patients were given chemotherapy, if the treatment was working, serum levels would rapidly decrease in the first three to four weeks after treatment."
Each year there are 1.3 million new cases of breast cancer on a worldwide basis. 25% of these new cases are HER-2 positive, and a simple blood test could help physicians in making treatment decisions.1-3 In support of Breast Cancer Awareness month, Siemens will feature Serum HER-2/neu on the Times Square Super Sign.
References:
1. Schwartz MK, et al. International Journal of Biological Markers 2000;15(4):324.
2. Lipton A, et al. Journal of Clinical Oncology 2002;20(6):1467.
3. Esteva FJ, et al. Journal of Clinical Oncology 2002;20(7):1800.
Assay Information: Serum HER-2/neu
Product Information: ADVIA Centaur XP Immunoassay System
Brochure: Including Serum HER-2/neu in Metastatic Breast Cancer Monitoring[92 KB]
Brochure: An Evolution in HER-2/neu Monitoring[133 KB]
Brochure: Understanding the Clinical Utility of Serum HER-2/neu [144 KB]
Medical Solutions Article: The Next Wave in Breast Cancer Management[1.10 MB]