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26079 HER2 Amp, Breast Cancer, FISH, Tissue (H2BR)

 HER2 Amp, Breast Cancer, FISH, Tissue (H2BR)
Test Code: HER2FSO
Useful For

​A prognostic indicator for patients with both node-positive or node-negative primary and metastatic breast cancer.

Guiding therapy, as patients with HER2 amplification may be candidates for therapies that target the human epidermal growth factor receptor 2 (HER2) protein (eg, trastuzumab [Herceptin], pertuzumab, lapatinib).

Confirming the presence of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2 overexpression by immunohistochemistry.

Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
​No ​Tissue ​Tissue Block ​ ​ ​ ​
​No ​Slides ​ ​ ​4un, 1 H&E ​2un, 1 H&E ​
Collection Processing Instructions

​Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

OR

Four consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

Specimen Stability Information
Specimen Type Temperature
​Tissue ​Ambient/Refrigerated
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories ​Monday through Sunday ​6 days ​Fluorescence In Situ Hybridization (FISH)
Reference Lab
Mayo Clinic Laboratories
Test Information
​Mayo tests HERBN - HER Breast IHC Automated NO Reflex and/or HERBM HER Breast Semi Quant IHC Manual may be reflexed from initial testing at added cost.  HERBN test will be added automatically when appropriate.
Reference Range Information
See Report
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88271 ​ ​2 ​DNA probe, each (first probe set) ​
​88291 ​ ​1 ​Interpretation and Report ​
​88271 ​ ​2 ​DNA probe, each; each additional probe ​if appropriate
​88271 ​ ​1 ​DNA probe, each; coverage for sets containing 3 probes ​if appropriate
​88271 ​ ​2 ​DNA probe, each; coverage for sets containing 4 probes ​if appropriate
​88271 ​ ​3 ​DNA probe, each; coverage for sets containing 5 probes ​if apporpriate
​88274 ​52 ​1 ​Interphase in situ hybridization, <25 cells, each probe set ​if appropriate
​88274 ​ ​1 ​Interphase in situ hybridization, 25 to 99 cells, each probe set ​if appropriate
​88275 ​ ​1 ​Interphase in situ hybridization, 100 to 300 cells, each probe set ​if appropriate
​88361 ​ ​1 ​​HER Breast IHC Automated No Reflex ​if appropriate
​88360 ​ ​1 ​HER Breast Semi Quant IHC Manual ​if appropriate
Ordering Applications
Ordering Application Description
​Centricity ​HER2 Amp, Breast Cancer, FISH, Tissue (HER2F)
​Cerner ​HER2 Amp, Breast Cancer, FISH, Tissue (HER2F)
​COM ​HER2 Amp, Breast Cancer, FISH, Tissue (HER2F)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
​No ​Tissue ​Tissue Block ​ ​ ​ ​
​No ​Slides ​ ​ ​4un, 1 H&E ​2un, 1 H&E ​
Collection Processing

​Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

OR

Four consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

Specimen Stability Information
Specimen Type Temperature
​Tissue ​Ambient/Refrigerated
Useful For

​A prognostic indicator for patients with both node-positive or node-negative primary and metastatic breast cancer.

Guiding therapy, as patients with HER2 amplification may be candidates for therapies that target the human epidermal growth factor receptor 2 (HER2) protein (eg, trastuzumab [Herceptin], pertuzumab, lapatinib).

Confirming the presence of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2 overexpression by immunohistochemistry.

Reference Range Information
See Report
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories ​Monday through Sunday ​6 days ​Fluorescence In Situ Hybridization (FISH)
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88271 ​ ​2 ​DNA probe, each (first probe set) ​
​88291 ​ ​1 ​Interpretation and Report ​
​88271 ​ ​2 ​DNA probe, each; each additional probe ​if appropriate
​88271 ​ ​1 ​DNA probe, each; coverage for sets containing 3 probes ​if appropriate
​88271 ​ ​2 ​DNA probe, each; coverage for sets containing 4 probes ​if appropriate
​88271 ​ ​3 ​DNA probe, each; coverage for sets containing 5 probes ​if apporpriate
​88274 ​52 ​1 ​Interphase in situ hybridization, <25 cells, each probe set ​if appropriate
​88274 ​ ​1 ​Interphase in situ hybridization, 25 to 99 cells, each probe set ​if appropriate
​88275 ​ ​1 ​Interphase in situ hybridization, 100 to 300 cells, each probe set ​if appropriate
​88361 ​ ​1 ​​HER Breast IHC Automated No Reflex ​if appropriate
​88360 ​ ​1 ​HER Breast Semi Quant IHC Manual ​if appropriate
For most current information refer to the Marshfield Laboratory online reference manual.