Test Details
Methodology
Fluorescence in situ hybridization (FISH)
Result Turnaround Time
3 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
Qualitative determination of HER-2/neu gene amplification; prognostic information regarding risk of recurrence and disease-related death; predict response to therapies, including targeted immunotherapy
Special Instructions
Direct any questions regarding this test to oncology customer service at 800-345-4363.
Limitations
Use of fixatives other than 10% formalin, fixation times less than six hours or greater than 48 hours may not yield reliable results.
Results of the HER-2/neu FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, nodal status, patient's age, hormone receptor status, and other known risk factors.
Specimen Requirements
Specimen
Tumor (formalin-fixed, paraffin-embedded)
Volume
One paraffin block or four unstained, positively charged tissue slides cut at 4 to 5 microns and dried overnight at 56°C.
Container
Paraffin block transport pouch or slide mailer.
Collection Instructions
FFPE tissue, preserved in 10% neutral buffered formalin, fixed for 18 to 24 hours. Extended fixation time might increase the incubation time required for pepsin digestion. ASCO/CAP 2013 guidelines recommend fixation time between 6 and 72 hours for breast tissue; however, special ASCO/CAP guidelines have not been established for gastric cancer samples.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Fixative other than neutral buffered formalin; quantity not sufficient for analysis; tumor other than gastric tumor
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 483340 | HER-2/CEP17 FISH, Gastric | 483341 | HER-2/neu FISH, Gastric | 31150-6 | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483326 | HER-2/CEP17 Ratio | 49683-6 | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483349 | Avg Num Her-2 signals/nucleus: | 74860-8 | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483359 | Avg Num CEP17 probes/nucleus: | 74861-6 | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483308 | Fixation Time | N/A | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483309 | Fixative | N/A | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483361 | Methodology: | 49549-9 | ||
| 483340 | HER-2/CEP17 FISH, Gastric | 483004 | Director Review | N/A | ||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483341 | |||||
| Result Code Name | HER-2/neu FISH, Gastric | |||||
| UofM | ||||||
| Result LOINC | 31150-6 | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483326 | |||||
| Result Code Name | HER-2/CEP17 Ratio | |||||
| UofM | ||||||
| Result LOINC | 49683-6 | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483349 | |||||
| Result Code Name | Avg Num Her-2 signals/nucleus: | |||||
| UofM | ||||||
| Result LOINC | 74860-8 | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483359 | |||||
| Result Code Name | Avg Num CEP17 probes/nucleus: | |||||
| UofM | ||||||
| Result LOINC | 74861-6 | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483308 | |||||
| Result Code Name | Fixation Time | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483309 | |||||
| Result Code Name | Fixative | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483361 | |||||
| Result Code Name | Methodology: | |||||
| UofM | ||||||
| Result LOINC | 49549-9 | |||||
| Order Code | 483340 | |||||
| Order Code Name | HER-2/CEP17 FISH, Gastric | |||||
| Order Loinc | ||||||
| Result Code | 483004 | |||||
| Result Code Name | Director Review | |||||
| UofM | ||||||
| Result LOINC | N/A |