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p16

Test ID: I P16 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
p16 is a tumor suppressor protein encoded by CDKN2A gene. Positive staining (overexpression) correlates with oncogenic HPV infection and HPV-independent mechanisms found in head and neck cancer and anogenital lesions.
Requisition Forms
Immunohistochemistry Requisition

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
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

Cyclin-dependent kinase 4 inhibitor A, Cyclin Dependent Kinase Inhibitor 2A, CDKN2A, P16-INK4A, p16-INK4a, P16INK4A, CDK4I, Multiple tumor suppressor 1, MTS-1, Tumor suppressor ARF, Alternative reading frame, ARF

Test Method
Immunohistochemistry
Methodology Category
IHC
Regulatory Status
IVD
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.