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c-kit, CD117

Test ID: I CD117 CPT Code: 88342

Expected Turnaround Time
2 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
CD117 (c-kit) is a proto-oncogene activated in gastrointestinal stromal tumors (GISTs). This IHC stain highlights mast cells (normal and abnormal) in the assessment of mast cell neoplasms, and is used to confirm GIST. Staining is also observed in mast cells and myeloid stem cells.


Specimen Requirements


Specimen Requirements
  • Fresh Tissues: Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): FFPE Block, Formalin Fixed
  • Unstained slides: 2 slides (3-5 μM) per stain (min 1 slide per stain), Formalin Fixed

Specimen Stability
  • Fresh Tissue Tissues: ≤ 72 Hours
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): Indefinite
  • Unstained slides: Indefinite
  • Stained slides: Indefinite

Storage Requirements

15°C to 25°C


Shipping Conditions
Ambient

Shipping Recommendations
  • Fresh Tissues: AMBIENT
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks) and unstained slides: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
  • Specimens may be transferred to 70% alcohol for transportation purposes after fixation in 10% NBF or B plus.

Specimen Rejection Criteria

Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected. 


Test Details


Synonyms

KIT Proto-Oncogene, Receptor Tyrosine Kinase 2, SCFR 2, V-Kit Hardy-Zuckerman 4 Feline Sarcoma Viral Oncogene Homolog 2, Mast/Stem Cell Growth Factor Receptor Kit 2, PBT, Tyrosine-Protein Kinase Kit, Piebald Trait Protein, Proto-Oncogene C-Kit, P145 C-Kit


Test Method
Immunohistochemistry

Methodology Category
IHC

Regulatory Status
IVD, CE-marked

Special Considerations
  • Fresh Tissues: Specimens may be fixed in formalin for 24-72 hours by collection sites, then transferred to 70% ethanol and stored at 2-8°C for longer term storage if needed. Samples must be tested 3 months after placing in ethanol.
  • Unstained slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.