HER2 Amplification Associated with Breast Cancer, FISH, Tissue
Method Description Describes how the test is performed and provides a method-specific reference
The test is performed using the PathVysion HER2 DNA probe set (Abbott Molecular) with a HER2 probe and a chromosome 17 centromere probe (D17Z1). Paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin (H and E)-stained slide are performed by a pathologist. Using the H and E slide as a reference, target areas are etched with a diamond-tipped etcher on the back of the unstained slide to be assayed. The probe is hybridized to the appropriate target areas and 2 technologists each analyze 30 interphase nuclei (60 total) with the results expressed as the average ratio of human epidermal growth factor receptor 2 (HER2) signals as compared to D17Z1 signals. The results are interpreted based on the 2013 guidelines established by the American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP), available at http://www.cap.org/apps/docs/committees/immunohistochemistry/validated_dual_probe_ish_assay.pdf. Reflex testing using the HER2/D17S122 probe will be performed when the HER2/D17Z1 result is equivocal (based on 2013 ASCO/CAP guidelines).(Unpublished Mayo method)
PDF Report Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Samples processed Monday through Sunday. Results reported Monday through Friday, 8 a.m.-5 p.m. CST.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Slides and H&E used for analysis are retained by the laboratory. Client provided paraffin blocks and extra unstained slides (if provided) will be returned after testing is complete.
Performing Laboratory Location The location of the laboratory that performs the test