Solid Tumors

Ki67 is a nuclear protein expressed in proliferating cells, which is detected by a primary monoclonal rabbit anti-human Ki67 antibody (clone 30-9). Ki67 expression level is determined by the percentage of appropriately stained tumor cells.

disease state indication(s)
Breast Cancer

clinical use
Ki-67 (also called MIB-1) is a nuclear protein expressed in proliferating cells. The Ki-67 proliferation index is prognostic, with higher values correlating with more aggressive disease and poorer 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.
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)