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Breast Cancer

The serum HER-2/neu Test and Metastatic Breast Cancer

Serum HER-2

serum HER-2/neu: Helping Women with Metastatic Breast Cancer

The serum HER-2/neu test is a simple blood test for over 150,000 women living with metastatic breast cancer.1 For the thousands of women diagnosed with metastatic breast cancer each year, the Siemens serum HER-2/neu test is the automated serum HER-2/neu test available for sale in the U.S. for monitoring their Serum HER-2/neu status during therapy. The serum HER-2/neu test is indicated for follow-up and monitoring patients with metastatic breast cancer and initial serum level >15 ng/mL.
 

serum HER-2/neu Status: Providing Critical Information for Metastatic Disease Assessment

Less than 15% increase is considered to indicate a lack of progression. Increase of equal or greater than 15% was considered to indicate progression.*

Monitoring serum HER-2/neu levels yields important information about response to therapy and cancer progression, and may help physicians make more informed decisions when developing and modifying patient treatment regimen. 2-4  

Understanding the serum HER-2/neu test

How to use a blood-based HER-2/neu immunoassay for active surveillance during treatment.**

serum HER-2/neu Progression Chart

Clinical course and serum HER-2/neu level


For the actual performance of the assay and claims to each, please to refer to the assay IFU (Atellica SMN# 10308994 and Centaur SMN # 10995591) .


Product availability may vary by country and is subject to regulatory requirements.

* For the ADVIA Centaur® system a point-to-point increase or decrease of 15% reflects response or progression.

**The clinical utility of the measurement of HER-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established 

2

Eppenberger-Castori, S., Klingbiel, D., Ruhstaller, T. et al. Plasma HER2ECD a promising test for patient prognosis and prediction of response in HER2 positive breast cancer: results of a randomized study - SAKK 22/99. BMC Cancer, 2020. 20:114.

3

Perrier et al. The extracellular domain of Her2 in serum as a biomarker of breast cancer. Laboratory Investigation, 2018. 98:696-707.

4

Mokuyasu, S and Suzuki, Y. Clinical Utility of Serum Human Epidermal Growth Factor Receptor Type 2 Testing as a Marker of Therapeutic Response in Tissue HER2-Positive Breast Cancer Patients. Int J Cancer, 2017. 4:089.

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