TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

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

Method Description Describes how the test is performed and provides a method-specific reference

Testing is performed using FDA-approved Ventana Pathway HER2 (4B5) rabbit monoclonal primary antibody and a proprietary detection system.(Package insert: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody)

 

Scoring is performed according to ASCO/CAP guidelines as follows:

-Score of 3+ is defined as circumferential membrane staining that is complete, intense and in greater than 10% of invasive tumor cells

-Score of 2+ is defined as weak to moderate complete membrane staining observed and  in greater than 10% of the invasive tumor cells; or circumferential membrane staining that is complete, intense and in less than or equal to 10% of invasive tumor cells

-Score of 1+ is defined as incomplete membrane staining that is faint or barely perceptible and in greater than 10% of the invasive tumor cells; or weak to moderate complete membrane staining observed and less than 10% of the invasive tumor cells

-Score of 0 is defined as no staining observed or membrane staining that is incomplete and is faint or barely perceptible and in less than or equal to 10% of the invasive tumor cells.(Wolff AC, Hammond ME, Hicks DG, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. [published online ahead of print May 30, 2018]. J Clin Oncol. doi: 10.1200/JCO.2018.77.8738.)

PDF Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to14 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Until 1 week after results are reported. Materials made at Mayo Clinic may be retained at Mayo Clinic indefinitely.

Performing Laboratory Location Indicates the location of the laboratory that performs the test

Rochester