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Transcript

ReachMD Announcer:
Welcome to ReachMD. This medical industry feature, titled, The Role of Dual Stain Technology in Examining HPV-Positive Screening Results, is sponsored by Roche.

Voiceover:
The goal of cervical cancer screening is to identify disease early and with certainty—before cervical pre-cancerous disease develops into actual cancer. 

Successful cervical cancer screening programs are based on two fundamental principles:

The first is risk stratification, which means identifying who is at risk and what their risk is.

And the second principle is disease stratification, which means identifying who would actually benefit from intervention

Now HPV testing plays an important role in cervical cancer screening because it’s significantly more sensitive than Pap cytology at detecting high-grade cervical dysplasia.

However, not every patient who’s HPV positive will develop cervical cancer.

So the challenge is to determine the best triage option to identify which HPV-positive women are truly at risk for developing cervical cancer and would benefit most from colposcopy.

One of the options available to us is biomarker dual staining or CINtec PLUS Cytology. This is an immunohistochemistry test that simultaneously detects p16 and Ki67 biomarker proteins, which are both involved in the control and regulation of the cell cycle progression.

So p16, which appears as a brown stain, is part of the Retinoblastoma protein mediated control of the G₁ to S phase transition.

It triggers cell cycle arrest in the course of cellular differentiation processes and provides anti-proliferative effect during cell cycle progression.

Ki67, on the other hand, appears as a red stain and is a marker of cell proliferation and cell division. It’s only expressed in actively dividing cells.

Now if p16 and Ki67 are expressed in the same cell at the same time, it indicates cell cycle deregulation, which is the hallmark of transforming HPV infection.

A positive dual stain test result is associated with a greater risk for developing high-grade cervical dysplasia, so these patients should be immediately referred to colposcopy.

A negative dual stain result, on the other hand, is associated with a low risk for developing high-grade cervical dysplasia. So, in this case, patients can safely return for follow-up screening without an increased risk for developing cervical cancer.

So CINtec PLUS Cytology or dual stain is a triage solution that provides better risk stratification for HPV-positive screening results, which allows for the appropriate management of patients at every level of risk.

ReachMD Announcer:
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