Item # 06489876

Serum HER-2 Controls

Item # 06489884

Intended Use
For In Vitro Diagnostic use

The HER-2/neu ELISA is an in vitro, diagnostic device intended for use in the quantitative determination of serum HER-2/neu in women with metastatic breast cancer who have an initial value of 15 ng/mL or greater. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the serum measurement of HER-2/neu as a prognostic indicator for early recurrence and in the management of patients on immunotherapy regimens has not been fully established.

Monitoring Serum HER-2/neu to Help Manage Metastatic Breast Cancer Patients

Metastatic breast cancer (MBC) patients who overexpress the HER-2/neu protein tend to have a worse prognosis and a more aggressive disease that can be resistant to certain types of chemotherapy [1]. HER-2/neu protein overexpression is determined by running a tissue test like immunohistochemistry. If a patient overexpresses the HER-2/neu protein, they are considered HER-2/neu-positive and a candidate for HER-2/neu-targeted therapy such as trastuzumab. HER-2/neu-targeted therapy is helping to improve survival rates for HER-2/neu-positive, MBC patients everywhere [2].

Serum HER-2/neu testing does not determine HER-2/neu overexpression but is complementary to tissue testing because it can be used to help monitor certain patients on HER-2/neu-targeted therapies once tissue testing already has established that the patient overexpresses HER-2/neu. The serum HER-2/neu ELISA measures a portion of the protein present on the outside surface of cells. This portion, often referred to as the extracellular domain (ECD), can cleave off into the blood of MBC patients. Serum HER-2/neu testing can measure the amount of HER-2/neu ECD shed into the blood.

The HER-2/neu ELISA is a simple, non-invasive serum test that can be used as a clinical tool for monitoring and managing certain patients with MBC when used in conjunction with clinical and other diagnostic procedures. When serum values are equal to or greater than 15 ng/mL, the test can be used to monitor a patient’s HER-2/neu status and has been shown to parallel the clinical course of disease regardless of a patient’s treatment regimen [3-8]. Increasing levels in serum can reflect disease progression while decreasing levels can reflect treatment response or stable disease [8-13]. Monitoring the changes of serum HER-2/neu levels can help manage these metastatic breast cancer patients. The clinical utility of serum measurement of HER-2/neu as a prognostic indicator for early detection of recurrence and in the management of patients on immunotherapy regimens has not been fully established.


Establish a Baseline Serum HER-2/neu

Upon a diagnosis of MBC, a baseline serum HER-2/neu level should be established. Patients with an initial serum HER-2/neu level equal to or greater than 15 ng/mL should have subsequent monitoring. Regardless of whether a HER-2/neu tissue test is negative or positive for overexpression of HER-2/neu, it is important to establish a serum HER-2/neu baseline. Some studies have noted a possible discordance between HER-2/neu expression in primary versus metastatic breast cancer tumors [14,15]. However, serum HER-2/neu levels can become elevated in patients whose initial serum HER-2/neu value was less than 15 ng/mL [16]. This may indicate a change in HER-2/neu status as a result of disease progression.

Use In Conjunction with Other Diagnostic Procedures such as Traditional Tumor Marker Tests

Unlike traditional tumor markers, the HER-2/neu oncoprotein, which is quantitatively measured by the serum HER-2/neu ELISA, is derived from a known oncogene which is biologically involved in converting normal cells to cancer cells. Serum HER-2/neu testing can offer a real-time assessment of a patient’s HER-2/neu status. A number of studies have investigated the clinical utility of monitoring serum HER-2/neu in conjunction with other diagnostic procedures such as tumor marker tests [8,17,18]. In particular, Dnistrian AM et al. found that measuring serum HER-2/neu levels in conjunction with certain tumor markers helped monitor patient response to targeted therapy [18].

Monitor the Course of Disease Regardless of Therapy

As previously mentioned, many studies of patients with MBC receiving hormone or chemotherapy have shown that longitudinal changes in serum HER-2/neu levels reflect the clinical course of a patient’s disease [9]. Other reports indicate that patients with MBC whose serum HER-2/neu level remained below 15 ng/mL when monitored over a period of time were responding to certain therapies [5,11,13]. Numerous studies have evaluated the clinical utility of monitoring serum HER-2/neu levels in MBC patients treated with several types of therapies, including trastuzumab plus various combinations of chemotherapy.

Days from First Draw Monitoring of a 74-year-old Stage Iv breast cancer patient with the serum HER-2/neu ELISA. Longitudinal changes inin serum HER-2/neu levels correlate with changes in disease status.

Days from First Draw
Monitoring of a 74-year-old Stage Iv breast cancer patient with the serum HER-2/neu ELISA. Longitudinal changes inin serum HER-2/neu levels correlate with changes in disease status.

Principle of the Assay

The Serum HER-2/neu ELISA test is a sandwich enzyme immunoassay that utilizes a mouse monoclonal antibody for capture and a different biotinylated mouse monoclonal antibody for the detection of human HER-2/neu protein. Both capture and detector reagents specifically bind to the extracellular domain of HER-2/neu protein. The Capture Antibody has been immobilized on the interior surface of microtiter plate wells. To perform the test, an appropriate volume of specimen is incubated in the coated well to allow binding of the antigen by the Capture Antibody. The immobilized antigen is then reacted with the detector antiserum. The amount of Detector Antibody bound to antigen is measured by binding it with a streptavidin/horseradish peroxidase conjugate, which then catalyzes the conversion of the chromogenic Substrate o-phenylenediamine (OPD) into a colored product. The colored reaction product is quantitated by spectrophotometry and is related to the amount of HER-2/neu protein in the sample. For instructions, see the Detailed Protocol and Evaluation of Results sections of the assay protocol. Results are available in one day for customers who require a standardized, reliable result for comparing values within the laboratory or between laboratories.


Purchase of this kit licenses its use under the following U.S. patents 5,401,638 and 6,861,511.

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serum her2 elisa kit

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Nuclea Diagnostics LLC is a fully owned subsidiary of Nuclea Biotechnologies


 *A study funded with Nuclea Biotechnologies Oncogene Science ELISA kits.

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  2. Brufky AM, Mayer M, Rugo HS, et al. Central nervous system metastases in patients with HER2-positive metasatic breast cancer: incidence, treatment, and survival in patients from registHER. Clin Cancer Res.2011 Jul 15;17(4):4834-43.
  3. *Koestler WJ, Schwab B, Singer CF, et al. Monitoring of serum HER-2/neu predicts response and progression-free survival to trastuzumab-based treatment in patients with metastatic breast cancer. Clin Cancer Res 2004;10(5): 1618-1624.
  4. Esteva FJ, Cheli CD, Fritsche H, et al. Clinical Utility of Serum HER-2/neu in Monitoring and Prediction of Progression-free Survival in Metastatic Breast Cancer Patients Treated with Trastuzamab-based Therapies. Breast Cancer Res, 2005. 7(4): R436-R443.
  5. *Schippinger W, Regitnig P, Bauernhofer T, et al. The course of serum HER-2/neu levels as an independent prognostic factor for survival in metastatic breast cancer. Oncol Rep 2004;11 (6): 1331-1336.
  6. *Schondorf T, Hoopmann M, Warm M, et al. Serologic concentrations of HER-2/neu in breast cancer patients with visceral metastases receiving trastuzumab therapy predict the clinical course. Clin Chem 2002; 48:1360-1362.
  7. Schwartz MK, Smith C, Schwartz DC, et al. Monitoring therapy by serum HER-2/neu. Int J Biol Markers 2000;15: 324-329.
  8. Fehm T, Gebauer G, Jager W. Clinical utility of serial serum c-erbB-2 determinations in the follow-up of breast cancer patients. Breast Cancer Res Treat 2002; 75: 97-106.
  9. Esteva FJ, Valero V, Booser D, et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2002;20 (7): 1800-1808.
  10. Colomer R, Montero S, Lluch A, et al. Circulating HER-2 extracellular domain and resistance to chemotherapy in advanced breast cancer. Clin Cancer Res 2000; 6:2356-2362.
  11. *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.
  12. Sørensen PD, Jakobsen EH, Langkjer ST, et al. Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting. Clin Chem Lab Med, 2009.47(9): 1117-23.
  13. *Lipton A, Leitzel K, Ali SM, et al. Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy. Cancer. 2011 Nov 1;117 (21): 5013-20.
  14. 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.
  15. 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.
  16. *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.
  17. Molina R, Jo J, Filella X, et al. C-erbB-2, CEA and CA 15.3 serum levels in the early diagnosis of recurrence in breast cancer patients. Anticancer Res 1999;19: 2551-2555.
  18. Dnistrian AM, Schwartz MK, Schwartz DC, et al. Significance of serum HER-2/neu oncoprotein, CA 15-3 and CEA in the clinical evaluation of metastatic breast cancer. J Clin Ligand Assay 2003; 25: 215-220.