The p16 biomarker is over-expressed (produced) in response to HPV. It is therefore a surrogate marker for HPV disease.

Patients with HPV have a different survival or outcome so it is important to be able to distinguish this by documenting the p16 results. Testing is performed by immunohistochemistry (IHC) which is inexpensive and has near universal availability. It has an easily standardized interpretation. HPV testing is usually performed through DNA testing which is more expensive and less widely available. HPV testing also has technically more variability with the interpretation.

p16 is a tumor suppressor protein also known as cyclin-dependent kinase inhibitor 2A. The p16 biomarker is over-expressed (produced) in response to HPV. It is therefore a surrogate marker for HPV disease.

0	p16 Negative; Nonreactive
1	p16 Positive; Diffuse, Strong reactivity
8	Not applicable: Information not collected for this case (If this time is required by your standard setter, use of code 8 will result in an edit error).
9	Not tested for p16; Unknown
Blank	Diagnosis year prior to 2021

Note 1: This SSDI is effective for diagnosis years 2022+

• For cases diagnosed 2018-2021, leave this SSDI blank

Note 2: Code 0 for p16 expression of weak intensity or limited distribution.

Note 3: This data item must be based on testing results for p16 overexpression.

• A statement of a patient being HPV positive or negative is not enough to code this data item
• Testing for HPV by DNA, mRNA, antibody, or other methods should not be coded in this data item
• Do not confuse p16 with HPV 16, which is a specific strain of virus