GeneticsOncology

Her2/neu By FISH

Normal Range
< 2.0 (Negative)
Sample Type
Paraffin-embedded Tissue
Fasting
No
Unit
Ratio

Function

HER2 (Human Epidermal Growth Factor Receptor 2) by Fluorescence In Situ Hybridization (FISH) is a molecular test used to determine the amplification of the HER2 gene. In certain cancers, particularly breast and gastric cancers, the HER2 gene is over-replicated, leading to an overabundance of the HER2 protein on the cell surface. This protein signals the cells to grow and divide uncontrollably. While Immunohistochemistry (IHC) measures the protein, FISH measures the actual number of gene copies, making it the 'gold standard' for precision.

Why it is Ordered

This test is critical for oncology treatment planning. It is ordered for:

  • All newly diagnosed invasive breast cancers.
  • Recurrent or metastatic breast cancer cases.
  • Advanced or metastatic gastric or gastroesophageal junction adenocarcinomas.
  • Clarifying 'equivocal' (IHC 2+) results from immunohistochemistry tests.

Associated Conditions

The primary focus is HER2-positive Breast Cancer and HER2-positive Gastric Cancer. HER2-positive tumors tend to be more aggressive and grow faster than HER2-negative tumors. However, the identification of HER2 amplification is a significant clinical opportunity because these cancers respond exceptionally well to targeted therapies such as Trastuzumab (Herceptin), Pertuzumab, and T-DM1. Determining HER2 status is a prerequisite for prescribing these life-saving HER2-targeted agents, which have drastically improved the prognosis for patients who would otherwise have a poor outlook.

Why Context Matters

HER2 FISH results can be complex to interpret, especially in cases of 'polysomy' (where the entire chromosome 17 is duplicated) or 'genetic heterogeneity' (where only some cells in the tumor show amplification). A second opinion by a specialized breast or molecular pathologist is valuable if the ratio is near the cutoff (e.g., 2.0) or if the IHC and FISH results are discordant, as this can determine whether a patient is eligible for high-cost, high-impact targeted therapy.

Lab ranges are statistical averages, not biological laws. "Normal" for a 20-year-old male isn't normal for a 60-year-old female.

Clinical References

Source-of-truth databases and clinical guidelines for Her2/neu By FISH:

Related Indicators

DR

Medically Reviewed by Dr. Binoy Babu, MBBS

Board Certified Doctor • 10+ Years Clinical Experience

Dr. Babu is a practicing physician dedicated to empowering patients with clear, actionable medical information. He founded 2opi to bridge the gap between complex lab reports and patient understanding, ensuring everyone has access to a reliable second opinion.

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