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Breast Cancer

HER2 Test - Breast Cancer Biomarker

This HER2 test determines whether a tumor overexpresses the HER2 protein or has HER2 gene amplification to identify eligibility for HER2‑targeted therapies. Early, accurate HER2 detection helps avoid ineffective treatments and can reduce the risk of cancer progression and recurrence.

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Key Insights

  • Understand how this test reveals your tumor’s biology—whether HER2 is driving cancer cell growth through extra receptors or gene amplification.
  • Identify receptor status (HER2-positive, HER2-negative, or HER2-low) that can explain fast-growing tumors, clarify prognosis, and shape treatment pathways.
  • Learn how tumor genetics, sampling site, prior therapy, and lab method (immunohistochemistry vs in situ hybridization) influence results and their meaning.
  • Use insights to guide targeted therapy discussions, surgical and chemotherapy planning, and clinical trial eligibility in partnership with your oncology team.
  • Track how results change over time to monitor disease evolution or re-test a recurrence or metastasis when biology may have shifted.
  • When appropriate, integrate this test with hormone receptor status (ER/PR), proliferation markers, or genomic profiling to build a complete picture of breast cancer behavior.

What Is a HER2 Test?

A HER2 test measures whether breast cancer cells make too much of the HER2 protein (a cell-surface growth receptor) or carry extra copies of the ERBB2 gene that codes for it. Most often, the sample is tumor tissue from a core needle biopsy or surgery. Pathologists assess HER2 protein by immunohistochemistry (IHC) and, when needed, confirm gene status with in situ hybridization (ISH), such as fluorescence in situ hybridization (FISH). Results are reported as categories (IHC 0, 1+, 2+, or 3+; ISH amplified or not amplified) against established guidelines to determine HER2-positive, HER2-negative, or HER2-low status. Some centers also use next-generation sequencing or, in select metastatic settings, blood-based assays, but tissue HER2 testing remains the standard for clinical decision-making.

Why this matters: HER2 status reflects how aggressively a tumor is signaling for growth and how likely it is to respond to HER2-targeted therapies. It connects to core systems like cell proliferation, survival signaling, and metastatic potential. Testing provides objective data at diagnosis and at progression to uncover drivers of disease, refine prognosis, and map a precise treatment strategy—often before symptoms or imaging tell the full story.

Why Is It Important to Test Your HER2?

HER2 is like a growth “antenna” on a breast cancer cell. When there are too many antennas (protein overexpression) or too many instruction manuals for making them (ERBB2 gene amplification), the cell hears louder signals to divide, invade, and resist normal checks and balances. A her2 test reveals whether this pathway is in the driver’s seat. That single insight ties to practical realities: tumors with high HER2 activity can grow and spread faster, but they are also uniquely targetable with HER2-directed therapies. In other words, knowing HER2 turns a blurry picture into a map you can act on with your care team.

Testing is especially relevant at the time of diagnosis; whenever biopsy shows invasive breast cancer; when cancer recurs or metastasizes (biology can change); and when pathology is borderline on routine staining. It is also important in less common scenarios—such as male breast cancer—because HER2 can still be the key growth signal. Pathology reports translate this biology into clear categories. IHC 3+ is typically HER2-positive; IHC 2+ prompts confirmatory ISH testing; amplified ISH results also indicate HER2-positive disease. IHC 0–1+ is considered HER2-negative, and a subset within this range is now described as HER2-low (IHC 1+ or 2+ with negative ISH), a classification that has emerging treatment implications though ongoing research continues to refine best practices.

Zooming out, HER2 testing is central to prevention-minded oncology: it helps catch high-risk biology early, guides whether HER2-targeted agents are likely to help, and provides a baseline for tracking how a tumor adapts under treatment. Repeating the test on a new site of disease can reveal a shift in receptor status—something we see in real-world cohorts—which can open or close specific therapeutic options. The goal is not to “pass” or “fail,” but to surface the right information at the right time so your plan fits the tumor you have today. Clinical guidelines from expert groups have standardized interpretation to reduce guesswork, though nuanced cases still benefit from subspecialty pathology review.

What Insights Will I Get From a HER2 Test?

Your report shows how strongly the tumor expresses the HER2 protein (IHC score 0, 1+, 2+, or 3+) and, when indicated, whether the ERBB2 gene is amplified by ISH (often reported as a ratio of HER2 signals to a reference such as CEP17). “Normal” here means levels typical of non–HER2-driven tumors, while “positive” indicates biologically meaningful overexpression or amplification that often responds to HER2-targeted therapy. Context matters: an IHC 2+ result is indeterminate on its own and gains meaning only with the ISH result.

Balanced or negative values suggest the tumor is not primarily relying on the HER2 pathway. That can point your team toward other drivers—like hormone receptors or specific genomic alterations—when planning therapy. Variation is expected across patients and even within the same tumor; factors like sample handling, prior therapy, and tumor heterogeneity can influence results.

Higher values (IHC 3+ and/or ISH-amplified) indicate HER2-driven biology that may be more aggressive but also more targetable. Lower values (IHC 0–1+) indicate HER2-negative disease; HER2-low (IHC 1+ or 2+ with negative ISH) reflects minimal protein expression without gene amplification. Abnormal does not equal “worst” or “best” on its own—these categories guide further evaluation and, with your clinician, inform a tailored plan.

The real power is in pattern recognition over time. Interpreted alongside estrogen and progesterone receptor status, tumor grade, stage, imaging, and—when appropriate—genomic profiling, HER2 results help reveal trends such as stable biology versus evolution under treatment. That perspective supports early detection of change, smarter sequencing of therapies, and personalized decisions that align with your goals and life.

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Frequently Asked Questions About

What do HER2 tests measure?

HER2 tests measure the level of HER2 (ERBB2) in tumor cells—either overexpression of the HER2 protein on the cell membrane or amplification (increased copy number) of the HER2/ERBB2 gene; tumors with elevated HER2 are often driven by HER2 signaling and can behave more aggressively.

Common methods are immunohistochemistry (IHC) to assess protein expression (scored 0–3+) and in situ hybridization (FISH/CISH/SISH) to detect gene amplification; IHC 3+ or evidence of gene amplification on ISH is considered HER2-positive and guides prognosis and eligibility for HER2‑targeted therapies, while equivocal IHC (2+) typically requires reflex ISH testing.

How is your HER2 sample collected?

HER2 status is most commonly determined from a tumor tissue sample obtained during a biopsy or surgical removal of the tumor (for example, a core needle biopsy, fine‑needle aspiration, or excisional/surgical specimen). The tissue is preserved (formalin‑fixed, paraffin‑embedded) and sent to a pathology lab where tests such as immunohistochemistry (IHC) and/or in situ hybridization (e.g., FISH) measure HER2 protein expression and/or HER2 gene amplification.

In some settings a blood draw can be used to measure circulating HER2 extracellular domain levels (serum HER2), which is a different type of test typically used for monitoring rather than primary diagnosis. Both tissue and blood samples are collected by trained healthcare professionals following standard clinical procedures.

What can my HER2 test results tell me about my cancer risk?

A HER2 test measures the amount of HER2 protein or the number of copies of the HER2 gene in your tumor cells. Results are reported as HER2-positive (overexpression/amplification), HER2-negative (no overexpression/amplification), or equivocal (uncertain). A positive result means your tumor shows higher HER2 levels, which is associated with more aggressive tumor growth and a higher chance of recurrence or spread compared with HER2-negative tumors; a negative result means your tumor is unlikely to be driven by HER2. An equivocal result often requires additional testing to clarify your HER2 status.

HER2 test results describe the biological behavior of the tissue tested and your personal HER2 level only; they do not by themselves measure inherited cancer risk or predict that cancer will definitely develop. Pathologists interpret these results in context, and sometimes confirmatory testing (different assay or repeat sampling) is used to ensure accuracy of the HER2 classification.

How accurate or reliable are HER2 tests?

HER2 status is determined mainly by two validated methods: immunohistochemistry (IHC), which measures HER2 protein expression and is reported as 0, 1+, 2+ (equivocal) or 3+ (positive); and in situ hybridization (ISH, e.g., FISH or CISH), which measures HER2 gene amplification and is used to confirm equivocal or unexpected IHC results. When performed according to established guidelines in an experienced, accredited laboratory—using proper tissue handling, fixation, and quality controls—the combined IHC→ISH approach is highly reliable for guiding therapy decisions.

How often should I test my HER2 levels?

HER2 should be tested at the time of initial cancer diagnosis (commonly breast or gastric cancers) to guide treatment decisions. You generally do not need routine, repeated HER2 testing if the cancer is stable and initial testing was conclusive; however, retesting is recommended if the cancer recurs, progresses, or metastasizes because HER2 status can change over time and treatment choices may differ for metastatic disease.

When retesting is needed, testing the recurrent or metastatic tissue is preferred; if tissue biopsy isn’t feasible, a validated liquid biopsy (circulating tumor DNA) may be considered. Clinical monitoring and imaging guide most follow-up; ask your oncologist for a plan tailored to your diagnosis, treatment, and any new symptoms.

Are HER2 test results diagnostic?

No — HER2 test results highlight patterns of imbalance or resilience—not medical diagnoses. They indicate whether HER2 protein expression or gene amplification is present, which reflects tumor biology but does not by itself establish a clinical diagnosis.

HER2 results must be interpreted alongside symptoms, medical history, imaging, pathology and other laboratory or biomarker data by a qualified clinician to reach a diagnosis and guide treatment decisions.

How can I improve my HER2 levels after testing?

HER2 is a characteristic of the tumor — you cannot reliably “improve” or change a tumor’s HER2 status with diet or lifestyle; instead HER2 results guide treatment. If your tumor is HER2‑positive, highly effective HER2‑targeted therapies exist (for example trastuzumab, pertuzumab, antibody–drug conjugates and HER2 tyrosine‑kinase inhibitors) and are used to control disease and improve outcomes; if your tumor is HER2‑negative those drugs are generally not indicated. If the result was equivocal or there’s a discrepancy between tests, reasonable next steps include repeat testing on the same or a different tumor sample, reflex FISH or molecular testing, or a second pathology opinion to clarify status.

Talk with your oncologist about treatment options (including approved HER2‑targeted agents and clinical trials), the meaning of your specific HER2 test result, and appropriate next diagnostic steps; lifestyle measures or supplements do not change HER2 expression and should not replace evidence‑based cancer treatment.

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