Test Details
Methodology
Immunohistochemistry (IHC)
Result Turnaround Time
4 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
HER2 is known to be expressed in various solid tumor types. This test is used to determine eligibility for HER2-targeted therapy in patients with any solid tumor. There is no equivalent FISH assay or FISH reflex scenario for this pan-tumor indication. For tumor types with specific test devices (e.g., breast, gastric, CRC), use of those tests is recommended instead.
Special Instructions
Please direct any questions regarding this test to Oncology Customer Service at 800-345-4363.
Limitations
Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield reliable results.
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tumor
Volume
One paraffin block or five unstained, positively-charged tissue slides cut at 4-5 microns and dried for one hour at 60°C
Minimum Volume
Three unstained slides
Container
Paraffin block transport pouch or slide mailer
Collection Instructions
Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between six and 72 hours according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24 hours.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Absence of tumor; unacceptable specimen types; non-indicated tumor types
References
Meric-Bernstam F, Makker V, Oaknin A, et al. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-Pan Tumor02 Phase II Trial. J Clin Oncol. 2024 Jan 1;42(1):47-58. PubMed 37870536
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 484500 | HER2 by IHC, Pan-Tumor | 484494 | HER2 Pan Can Result | 19146-0 | ||
| 484500 | HER2 by IHC, Pan-Tumor | 484496 | Scoring Guide | 8251-1 | ||
| 484500 | HER2 by IHC, Pan-Tumor | 484497 | Comment | 8251-1 | ||
| 484500 | HER2 by IHC, Pan-Tumor | 484498 | Director Review: | 72486-4 | ||
| Order Code | 484500 | |||||
| Order Code Name | HER2 by IHC, Pan-Tumor | |||||
| Order Loinc | ||||||
| Result Code | 484494 | |||||
| Result Code Name | HER2 Pan Can Result | |||||
| UofM | ||||||
| Result LOINC | 19146-0 | |||||
| Order Code | 484500 | |||||
| Order Code Name | HER2 by IHC, Pan-Tumor | |||||
| Order Loinc | ||||||
| Result Code | 484496 | |||||
| Result Code Name | Scoring Guide | |||||
| UofM | ||||||
| Result LOINC | 8251-1 | |||||
| Order Code | 484500 | |||||
| Order Code Name | HER2 by IHC, Pan-Tumor | |||||
| Order Loinc | ||||||
| Result Code | 484497 | |||||
| Result Code Name | Comment | |||||
| UofM | ||||||
| Result LOINC | 8251-1 | |||||
| Order Code | 484500 | |||||
| Order Code Name | HER2 by IHC, Pan-Tumor | |||||
| Order Loinc | ||||||
| Result Code | 484498 | |||||
| Result Code Name | Director Review: | |||||
| UofM | ||||||
| Result LOINC | 72486-4 |