Laboratory Services

Updated Test Information:

Test Description
P16
Specimen Type

Formalin-fixed, paraffin-embedded tissue blocks (FFPE). If tissue blocks are not available, unstained slides are acceptable (please submit 1-2 slides per antibody to be tested, cuts must be 4 microns thick).

Specimen Collection / Processing Instructions

Tissue removed during a surgical procedure and placed in 10% NBF soon after removal from the patient. Appropriate tissue for requested staining.

Required Information

Complete the Incyte Diagnostics requisition with the patient's demographics and relevant clinical history.

Stability

Ambient: Indefinite

Unacceptable Specimen Conditions

Slides or paraffin blocks with no tissue remaining. Samples fixed in fixatives other than 10% neutral buffered formalin. Paraffin blocks that have been overheated or frozen.

Department (code)

Histology

Methodology

IHC, Ventana Ultra Stainer

Estimated TAT

12 business days from receipt

Testing Schedule

Monday–Saturday

Retention

Blocks: 10 years
Slides: 10 years

CPT Code(s)

88341
88342

Additional Information

Incyte Diagnostics uses the Roche CINtec Histology assay to assess p16INK4a protein expression by light microscopy in formalin fixed paraffin-embedded tissues.  This test performed on the Ventana BenchMark Ultra immunohistochemistry instrument utilizes the mouse monoclonal antibody clone E6H4.  When used as an adjunct to H&E examination the CINtec Histology test aids in the diagnosis of cervical intraepithelial neoplasia (CIN).  Due to its important role in cell cycle regulation and cellular differentiation, overexpression of p16INK4a protein is indicative of certain high-risk human papilloma virus (HPV) infections in cervical, vaginal, and anal mucosa.  In the case of head and neck squamous cell carcinoma, the overexpression can be used as prognostic indicator.

Clone

E6H4 (Spokane, Bellevue, Richland)