• HER-2/neu is an oncoprotein, a class of proteins that are linked to tumor growth
• 20 to 30 percent of all breast cancers are HER-2/neu (c-erbB-2) positive ²
• 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

• Traditional HER-2/neu status assessment has been generally limited to testing tissue from primary breast cancer
• Serum HER-2/neu testing provides current or real-time assessment of a patient’s Serum 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

The Serum HER-2/neu test is for patients with metastatic breast cancer whose initial Serum HER-2/neu is greater than 15 ng/mL regardless of HER-2 positivity determined by tissue.

The Serum HER-2/neu test is used to monitor a patient’s HER-2/neu status once a diagnosis of metastatic breast cancer has been established. The chart above shows how the Serum HER-2/neu test is typically used as a monitoring tool complementary to tissue testing.

The Serum HER-2/neu test from Siemens Healthcare Diagnostics measures circulating levels of the HER-2/neu oncoprotein. It is a simple blood test, with reliable and easily interpreted results. This assay can be performed on the automated ADVIA Centaur® System or run manually using an ELISA method.

• Sandwich immunoassay
• Direct chemiluminescence technology
• Normal cutoff value of 15 ng/mL
• Two monoclonal antibodies that are specific for unique epitopes on the extracellular domain of the HER-2/neu oncoprotein

• Confidence in test results due to excellent precision and resistance to interference from HER-2/neu-based therapy ⁶
• Improved long-term patient monitoring due to low reagent lot-to-lot variability ⁷
• Broad assay range of 0.5 to 350 ng/mL
• Excellent reproducibility with a Total % CV Range of 3.2% – 5.7%
• 95% of normal patients have serum HER-2/neu levels below 15.2 ng/mL
• Serial changes in HER-2/neu were correlated with changes in clinical status for all patients whose pre-treatment HER-2/neu values exceeded 15 ng/mL. For each pair of serial measurements, an increase of equal or greater than 15% was considered to indicate progression (predictive value of 67%). For each pair of serial measurements, a decrease of less than 15% was considered to indicate a lack of progression (predictive value of 71%)

• Sandwich immunoassay
• Enzyme-linked immunoassay format
• Normal cutoff value of 15 ng/mL
• Two monoclonal antibodies that are specific for unique epitopes on the extracellular domain of the HER-2/neu oncoprotein

For more information about the assay performance and clinical reliability of Siemens Serum HER-2/neu ELISA test, please visit www.oncogene.com

<sup>Footnotes:

1. Valero V, Roche H, Pienkowski T, et al. BCIRG 007: Serum HER-2/neu levels in women with metastatic HER-2/neu-amplified breast cancer. J Clin Oncol. ASCO Annual Meeting Proceedings 2007, Abstract No: 1020
2. Slamon DJ, et al. Science 1987;235:177
3. http://www.mayoclinic.com/health/Herceptin/BR00012
4. Schwartz MK, et al. International Journal of Biological Markers 2000;15(4):324.
5. Lipton A, et al. Journal of Clinical Oncology 2002;20(6):1467.
6. Esteva FJ, et al. Journal of Clinical Oncology 2002;20(7):1800.
7. Ali SM, Carney WP, Esteva FJ, et al. Serum HER-2/neu and relative resistance to trastuzumab-based therapy in patients with metastatic breast cancer. Cancer. 2008 Sep 15;113(6):1294-301.
8. Lipton A, Leitzel K, Chaudri-Ross HA, et al. Decrease in serum extracellular domain of HER2 at 4 and 8 weeks is associated with prolonged progression-free survival on lapatinib monotherapy. Proceedings of the 31st Annual CTRC-AACR San Antonio Breast Cancer Symposium, 2008. December: Abstract No. 3140
9. Zidan J, Dashkovsky I, Stayerman C, et al. Comparison of HER-2 overexpression in primary breast cancer and metastatic sites and its effect on biological targeting therapy of metastatic disease. Br J Cancer. 2005 Sep 5;93(5):552-6.
10. Lower EE, Glass E, Blau R, Harman S. HER-2/neu expression in primary and metastatic breast cancer. 1: Breast Cancer Res Treat. 2009 Jan;113(2):301-6. Epub 2008 Feb 14.
11. Carney WP, Brown-Shimer S, Hamer PJ. Serum HER-2/neu testing can identify HER-2/neu positive patients previously classified as negative by tissue testing. American Association for Clinical Chemistry Annual Meeting Proceedings, 2008. Clin Chem Vol 54(56) Suppl, pg A130: Abstract No. C-96</sup>

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