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Test Code HERDM HER2, Breast, DCIS, Quantitative Immunohistochemistry, Manual with HER2 FISH Reflex


Advisory Information


This test is only for ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue. For gastroesophageal cancer, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual or HERGN / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex.



Shipping Instructions


Attach the green pathology address label included in the kit to the outside of the transport container.



Necessary Information


Include accompanying pathology report stating the final diagnosis.



Specimen Required


Supplies: Pathology Packaging Kit (T554)

Specimen Type:

Preferred: A paraffin-embedded tissue block containing breast cancer tissue that has been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours and shipped at ambient temperature

Acceptable: 5 unstained sections containing breast carcinoma on charged slides cut at 4 microns less than 1 month ago and shipped at ambient temperature. Tissue on the slides should have been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours.

Container/Tube: Pathology Packaging Kit (T554)

Collection Instructions:

1. Submit paraffin-embedded ductal carcinoma in situ or solid intracystic papillary carcinoma breast carcinoma tissue.

2. Paraffin blocks will be returned with final report.


Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

Pathology Test Request Form (T246) (http://www.mayomedicallaboratories.com/it-mmfiles/pathology-request-form.pdf)

Oncology Test Request Form (T729) (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

Useful For

Determining overexpression of HER2 protein on formalin-fixed, paraffin-embedded tissue sections in ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue with a reflex to FISH testing if the specimen is equivocal (2+)

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HER2F HER2, Breast Tumor, FISH, Ts Yes No

Testing Algorithm

Cases that are equivocal (2+) by immunohistochemical stain will reflex to HER2 amplification by FISH at an additional charge.

Method Name

Ventana Pathway Immunoperoxidase Stain with Manual Quantitative Immunohistochemistry

Reporting Name

HER BreastDCIS IHC Manual + Reflex

Specimen Type

Special

Specimen Minimum Volume

Entire specimen

Specimen Stability Information

Specimen Type Temperature Time
Special Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Reference Values

Reported as negative (0, 1+), equivocal (2+), and strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

2 days (HER2 IHC only); 8 days (if HER2F is added on)

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

88360

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HERDM HER BreastDCIS IHC Manual + Reflex In Process

 

Result ID Test Result Name Result LOINC Value
70980 Interpretation 50595-8
70981 Participated in the Interpretation No LOINC Needed
70982 Report electronically signed by 19139-5
70984 Material Received 81178-6
MA017 Tumor classification In Process
71623 Disclaimer 62364-5
71837 Case Number In Process