Test Details
Methodology
ER/PR: immunohistochemistry; HER-2/neu gene amplification status: fluorescence in situ hybridization (FISH)
Result Turnaround Time
5 - 6 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.
Test Includes
Estrogen/progesterone receptor (ER/PR) assay; HER-2/CEP17 FISH assay
Use
Provide prognostic information to aid the physician in determining risk of recurrence and potential benefits of therapy options for the breast cancer patient; HER-2/neu gene amplification status is a predictor of response to certain breast cancer treatments, including targeted immunotherapy.
Special Instructions
Please direct any questions regarding this test to oncology customer service at 800-345-4363.
Limitations
Use of fixatives other than 10% formalin may not yield equivalent or satisfactory results.
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tumor
Volume
One paraffin block
Container
Paraffin block transport pouch
Collection Instructions
Specimen should be fixed in 10% neutral-buffered formalin. Optimum fixation time is 12 to 24 hours, not to exceed 48 hours.
Storage Instructions
Maintain specimen at room temperature.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 480278 | Estrogen Receptor IHC | % | 14228-1 |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 480279 | Progesterone Rec. IHC | % | 14230-7 |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 480276 | Comment | 8251-1 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 480268 | Fixative | N/A | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 480299 | Fixation Time | N/A | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 480298 | Additional Information | 19147-8 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483249 | HER-2/neu FISH | 31150-6 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483299 | HER-2/CEP17 Ratio | 49683-6 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483328 | Avg Num Her-2 signals/nucleus: | 74860-8 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483329 | Avg Num CEP17 probes/nucleus: | 74861-6 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483332 | Number of Tumor Cells Counted: | 62361-1 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483334 | Number of Observers: | N/A | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483259 | Fixation Time | N/A | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483260 | Fixative | N/A | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483336 | Scoring Criteria | 19147-8 | |
| 495036 | Breast Ca Prog II, Paraffin | 74885-5 | 483002 | Director Review | N/A | |
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 480278 | |||||
| Result Code Name | Estrogen Receptor IHC | |||||
| UofM | % | |||||
| Result LOINC | 14228-1 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 480279 | |||||
| Result Code Name | Progesterone Rec. IHC | |||||
| UofM | % | |||||
| Result LOINC | 14230-7 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 480276 | |||||
| Result Code Name | Comment | |||||
| UofM | ||||||
| Result LOINC | 8251-1 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 480268 | |||||
| Result Code Name | Fixative | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 480299 | |||||
| Result Code Name | Fixation Time | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 480298 | |||||
| Result Code Name | Additional Information | |||||
| UofM | ||||||
| Result LOINC | 19147-8 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483249 | |||||
| Result Code Name | HER-2/neu FISH | |||||
| UofM | ||||||
| Result LOINC | 31150-6 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483299 | |||||
| Result Code Name | HER-2/CEP17 Ratio | |||||
| UofM | ||||||
| Result LOINC | 49683-6 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483328 | |||||
| Result Code Name | Avg Num Her-2 signals/nucleus: | |||||
| UofM | ||||||
| Result LOINC | 74860-8 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483329 | |||||
| Result Code Name | Avg Num CEP17 probes/nucleus: | |||||
| UofM | ||||||
| Result LOINC | 74861-6 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483332 | |||||
| Result Code Name | Number of Tumor Cells Counted: | |||||
| UofM | ||||||
| Result LOINC | 62361-1 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483334 | |||||
| Result Code Name | Number of Observers: | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483259 | |||||
| Result Code Name | Fixation Time | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483260 | |||||
| Result Code Name | Fixative | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483336 | |||||
| Result Code Name | Scoring Criteria | |||||
| UofM | ||||||
| Result LOINC | 19147-8 | |||||
| Order Code | 495036 | |||||
| Order Code Name | Breast Ca Prog II, Paraffin | |||||
| Order Loinc | 74885-5 | |||||
| Result Code | 483002 | |||||
| Result Code Name | Director Review | |||||
| UofM | ||||||
| Result LOINC | N/A |