Breast Cancer

Serum HER-2/neu, BR 27.29, and CA 15-3 Assays

Breast cancer is the most common cancer among women.1 Breast cancer survival rates have increased, and the number of deaths associated with this disease is steadily declining, largely due to factors such as earlier detection and a better understanding of the disease.2

BR 27.29 and CA 15-3 Assays

The Siemens Healthineers BR 27.29 and CA 15-3 assays are intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The BR 27.29 and CA 15-3 assays aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.3,4

Siemens Healthineers BR 27.29 and CA 15-3 Assay Benefits5,6

  • Achieve early detection of breast cancer to aid in monitoring disease recurrence.
  • Improve patient management by using an assay to detect circulating tumor markers, such as CA 27.29 and CA 15‑3, which can monitor response to therapy and can indicate disease status.
  • Gain lab efficiency by consolidating oncology testing onto one trusted system.

BR 27.29 system availability: Atellica® IM Analyzer and ADVIA Centaur® CP/ XP/XPT Immunoassay Systems.
CA 15-3 system availability: Atellica® IM Analyzer, ADVIA Centaur® CP/ XP/XPT Immunoassay Systems, Dimension Vista® Systems, and IMMULITE® 2000/2000 XPi Immunoassay System.


Serum HER-2/neu Assay

Studies have shown that up to 90% of metastatic breast cancer patients can have an elevated Serum HER-2/neu level. 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 (overexpression).

Siemens Healthineers offers the HER-2/neu assay for measurement of circulating levels of the HER-2/neu oncoprotein in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum HER-2/neu is greater than 15 ng/mL. 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.7-9

Siemens Healthineers Serum HER-2/neu Assay Benefits

  • Gain confidence in testing with a reliable and easily interpreted assay that has good precision and resistance to interference from HER-2/neu-based therapy.9
  • Enhance clinical reporting with a broad assay range of 0.5 - 350 ng/mL.
  • Improve long-term patient monitoring due to low reagent lot-to-lot variability.10 

Serum HER-2/neu Testing Algorithm for Metastatic Breast Cancer

The chart below shows how the Serum HER-2/neu test is typically used as a monitoring tool complementary to tissue testing.

System availability: Atellica® IM Analyzer and ADVIA Centaur® CP/ XP/XPT Immunoassay Systems.


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1http://www.who.int/cancer/detection/breastcancer/en/index1.html

2https://www.mayoclinic.org/diseases-conditions/breast-cancer/symptoms-causes/syc-20352470

310995282_EN Rev. 02, 2018-08

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5Abbate I, Correale M, Musci MD, Dragone D. Monoclonal antibody B27.29 against mucinous breast cancer associated antigen CA 27.29 in breast cancer. Breast Cancer Res Treatment. 1991;19(2):123.

6Dnistrain AM, Schwartz MK, Greenberg EJ, Smith CA, Schwartz DC, Maimonis P. Evaluation of a breast cancer antigen assayed on the Ciba Corning ACS:180 Automated Chemiluminescence System. J Tumor Marker Oncol. 1996;11(3):5–10.

7Schwartz MK, et al. International Journal of Biological Markers 2000;15(4):324.

8Lipton A, et al. Journal of Clinical Oncology 2002;20(6):1467.

9Esteva FJ, et al. Journal of Clinical Oncology 2002;20(7):1800.

10Ali 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.