Molecular biomarkers are finding wider application in the medical sciences, particularly oncology. A number of clinically validated biomarkers are currently used in practice for diagnosis, prognosis, patient identification, and to predict or assess treatment response.

Such gains have only recently made their way to cervical cancer screening, which is largely rooted in practices and protocols that have begun to change to encompass more current technologies.

As a result, definitive, actionable information is not always available for clinicians during screening for precancerous cervical disease. This is particularly the case with inconclusive Pap cytology or co-testing results (normal Pap cytology/positive HPV DNA), which are not easily resolved using established screening modalities.1

What are equivocal cytology results?

What is clinical accuracy in cervical cancer screening?

Biomarker-based testing can fill some of the gaps left by cytology and other screening technologies. An approach is currently available that incorporates qualitatively testing for the co-expression of two important proteins: p16INK4a (also referred to as p16) and Ki-67. These proteins are expressed and have clinical value in both cytologic and histologic samples, and are backed by a growing body of clinical evidence.2,3

Explore the p16 cell cycle protein

Explore the concept of p16/Ki-67 co-expression in cervical cancer screening