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HER-2 Blood Test (HER2)

The Oncogene Science® HER-2 Blood Test (HER-2 ELISA) is a simple, non-invasive serum test that can be used as a clinical tool for monitoring and managing patients with metastatic breast cancer when used in conjunction with clinical and other diagnostic procedures. The serum HER-2 Blood Test measures the portion of the HER-2 protein present on the outside surface of cells, referred to the extracellular domain, which is shed into the blood stream of both normal individuals and MBC patients. When serum values are equal to or greater than 15 ng/mL, the test can be used to help monitor a patient’s HER-2 levels for changes in clinical status such as response to therapy or progression of disease.

HER-2 refers to the Human Epidermal Growth Factor Receptor 2. It is a gene found in the body that makes proteins, which help control how a body’s cells grow, however overexpression of the protein is associated with aggressive breast cancer. Currently, tumors from breast cancer patients are tested semi-qualitatively for HER-2 positivity using a combination of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) methods and patients are separated into having either HER-2 positive or HER-2 negative breast tumor. Determination of the correct HER-2 tumor status is critically important for guiding the therapy of patients with HER-2 positive breast cancer since HER-2 targeted therapies are now used in the neoadjuvant, adjuvant and metastatic breast cancer settings. HER-2 proteins can also be found in the body’s blood stream and can be measured in the serum component of blood with a test referred to as the HER-2 Blood Test (HER-2 ELISA). The serum HER-2 test is complementary to IHC and FISH tests and in contrast to these tests that are generally only performed once on the tumor tissue, the serum HER-2 Blood Test can be used to monitor metastatic breast cancer (MBC) patients receiving a variety of therapies.

Nuclea Diagnostic/Oncogene Science Laboratories can be contacted at (617) 492-3900 x501 or by clicking here.