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)
Predictive Estrogen receptor status determines eligibility for hormonal therapies (such as tamoxifen)
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.
Tech-only (TC): 2 days
Global (TC & PC): 3 days
medicare moldx cpt code
Global (TC & PC) or Tech-only (TC)