: HER2 Gene Amplification by Specimen Qualitative Immunostain
: This test checks a tissue or specimen sample for extra copies (amplification) of the HER2 gene using an immunostain-based qualitative method. It helps determine whether a cancer may respond to HER2-targeted therapy.
[": A positive result means the HER2 gene appears amplified and may guide treatment decisions."]
Key facts at a glance
- LOINC
- 85319-2
- Short code
- Her2 Ag Br ca spec Ql ImStn
- Synonyms
- Her2 Ag Br ca spec Ql ImStn
- Category
- chemistry
- Sample
- serum
- Container
- Red-top tube (SST)
- Units
- N/A
- Fasting
- false
- Population
- adult
- Sex
- all
- Age range
- 18–65 years
- Method
- immune-stain
- Specimen volume
- 5 mL
- Stability
- Room temperature: 4h, Refrigerated: 24h, Frozen: 7d
- Hemolysis max
- 500
- Lipemia max
- 1000
- Icterus max
- 500
- TAT
- 4–24 hours
- Order
- routine
: What This Test Measures
: The test looks at the HER2 gene, which provides instructions for a protein that helps control cell growth. When the gene is amplified, cells can make too much HER2 protein, which may drive certain cancers to grow more aggressively.
: How the Test Is Performed
: A small sample of tissue or other specimen is collected, usually during a biopsy or surgery. In the laboratory, a qualitative immunostain method is used to assess whether HER2 gene amplification is present in the sample.
: What the Results Mean
: A positive or amplified result suggests the tumor may respond to drugs that target HER2. A negative or non-amplified result suggests HER2-targeted therapy may be less likely to help. Results are interpreted alongside other pathology findings.
: Why Your Doctor Ordered It
: Doctors order HER2 testing to help classify certain cancers and to decide whether HER2-targeted treatments are appropriate. It is commonly used in breast and gastric cancer evaluations but may be used in other settings.
Clinical interpretation
How abnormal results are interpreted and what conditions they suggest.
: HER2 amplification status is an important biomarker that guides treatment selection for HER2-targeted therapies. Accurate interpretation depends on proper specimen handling and may require confirmatory testing in some cases.
Short name
: HER2 Amplification (Specimen)
Frequently asked questions
: Does a positive HER2 result mean I have cancer?
: Will I need another test to confirm the result?
: Can treatment change based on this result?
Sources
- 1
- 2Lab Tests OnlineSource
- 3
Click any link to access the full source. PubMed Central (PMC) links provide free full-text access.
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
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Medically reviewed by WellAlly Editorial Team Last reviewed August 16, 2026. · Read our editorial policy