Solid Tumors

HER2 protein is detected by a primary monoclonal rabbit anti-human HER2 antibody (clone 4B5). HER2 expression level is determined by the staining pattern and percentage of invasive tumor cells, and is interpreted in accordance with CAP/ASCO Guidelines.

disease state indication(s)
Breast Cancer

clinical use
Predictive, Prognostic
HER2 status determines eligibility for targeted therapies (such as trastuzumab); HER2 positivity is prognostic for poor outcomes.

methodology/product platform
Immunohistochemistry (IHC)

specimen type and requirements
Preferred: One (1) formalin-fixed, paraffin-embedded (FFPE) block containing breast tumor with sufficient cells for analysis. Tissue specimens should be fixed in 10% neutral buffered formalin for 6 to 72 hours for ER/PR/HER2/Ki-67 testing.

Acceptable Alternative: At least 3 FFPE tissue sections per marker, cut at 4 μm thickness, plus accompanying H&E stained slide. Slides should be received at Genoptix within 5 weeks of sectioning; date of sectioning must be specified.

Specimens should be fixed in 10% neutral buffered formalin for at least 6 hours and up to 72 hours. The volume of formalin should be at least 10 times the volume of the specimen. Decalcification solutions with strong acids should not be used.

1. Specimens should be immersed in fixative within one hour of the biopsy or resection
2. If delivery of a resection specimen to the pathology department is delayed (e.g. specimens from remote sites), the tumor should be bisected prior to immersion in fixative. In such cases, it is important that the surgeon ensure that the identity of the resection margins is retained in the bisected specimen; alternatively, the margins may be separately submitted.
3. The time of removal of the tissue and the time of immersion of the tissue in fixative should be recorded and submitted to Genoptix.

Note: Store and ship at room temperature. May use refrigerated cold pack for transport during warmer months, but make sure cold pack is not in direct contact with specimen.

turnaround time
Tech-only (TC): 2 days
Global (TC & PC): 3 days

cpt code(s)
88360 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
FDA approved/cleared

ordering option
Global (TC & PC) or Tech-only (TC)