Solid Tumors

ER protein is detected by a primary monoclonal rabbit anti-human ER antibody (clone SP1). ER status is determined determined by the intensity and percentage of appropriately stained tumor cells, and is interpreted in accordance with CAP/ASCO Guidelines.

disease state indication(s)
Breast Cancer

clinical use
Predictive Estrogen receptor status determines eligibility for hormonal therapies (such as tamoxifen)

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.
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.
DO NOT FREEZE.

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)