Her-2/neu is an oncoprotein, a class of proteins that are linked to tumor growth
Extensive studies have shown that 20 to 30 percent of all breast cancers are HER-2/neu (c-erbB-2) positive
HER-2/neu positive breast cancer cells have an abnormal number of HER-2/neu genes per cell, which leads to the production of abnormally high levels of HER-2/neu
Overexpression of HER-2/neu has been shown to be an indicator of poor prognosis with patients exhibiting aggressive disease, decreased overall survival, and a higher probability of recurrence
Tissue and Serum HER-2/neu Testing
Traditional HER-2/neu status assessment has been generally limited to testing tissue from primary breast cancer
In cases of recurrent metastatic breast cancer, HER-2 status may be difficult to obtain by tissue testing, due to the location of the metastasis
Serum HER-2/neu testing provides current or real-time assessment of a patient’s HER-2/neu status with a minimally invasive procedure
Serum HER-2/neu testing enables physicians to:
Monitor changes in HER-2/neu levels over the course of metastatic disease
Assess response to treatment
Serum HER-2/neu Specifications
Sandwich immunoassay
Direct chemiluminescence technology
Two monoclonal antibodies that are specific for unique epitopes on the extracellular domain of the HER-2/neu oncoprotein
Approval
FDA
Sensitivity
0.5 ng/mL
Instrumentation Needed
ADVIA Centaur
Test Method
Direct chemiluminescence technology
Pricing
Product Description
Extensive studies have shown that HER-2/neu (c-erbB-2) positive breast cancer represents 20 to 30 percent of all breast cancers. In HER-2/neu positive breast cancer, the cancer cells have an abnormal level of HER-2/neu genes per cell which leads to abnormally high levels of the HER-2/neu cancer-causing proteins called oncoproteins. This causes the cancer cells to grow and divide quickly into more cancer cells. Overexpression of HER-2/neu has been shown to be an indicator of poor prognosis with patients exhibiting aggressive disease, decreased overall survival, and a higher probability of recurrence.
The Siemens Serum HER-2/neu test is the first FDA-cleared blood test for measuring circulating levels of the HER-2/neu oncoprotein in the follow-up and monitoring of patients with metastatic breast cancer. It is the only serum test available to monitor HER-2/neu baseline values and Serum HER-2/neu level changes over the course of the disease. Monitoring Serum HER-2/neu levels yields important information about response to therapy, and may help physicians make more informed decisions when developing and modifying patient treatment regimens.
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