Each year, over 604,000 women worldwide are diagnosed with cervical cancer and approximately 342,000 die from this preventable disease, caused by infection with high-risk human papillomavirus (HPV).

A recent study called the IMPACT trial demonstrated that Roche’s CINtec PLUS Cytology, when used as a triage test for high-risk HPV, showed  significantly higher sensitivity in detecting cervical pre-cancers in HPV-positive women compared to Pap cytology.

DocWire News spoke Dr. Carolyn Kay, an OB/GYN physician who serves on Roche’s medical affairs team, about the findings and clinical implications of this study.

DocWire News: Can you give us some background on yourself, and your role with Roche?

Dr. Carolyn Kay: Sure. So my name is Carolyn Kay. I’m an OB-GYN by background, and I’m currently the global medical affairs lead for Cervical Cancer Solutions. And what that means is that I’m part of a team at Roche that brings diagnostic technology to clinicians, labs, and patients.

So why this is important to me is that when I was seeing patients, I thought that we had mostly figured out cervical cancer screening. We have a Pap test and that’s done very, very well in driving down rates of cervical cancer. So it really didn’t seem to me like an area that was under any active breakthroughs because thanks to modern medicine, cervical cancer is just not as common as it used to be. But the truth really is that cervical cancer is largely preventable. And yeah, there are still women who are being taken from their families and communities by this. And it’s largely a disease of disparities. So there’s a lot of work to be done still.

Why are women with HPV so susceptible to cervical cancer?

HPV is actually pretty common. It’s something that can affect both men and women. And some studies say that there’s something like 80% of sexually active people can have HPV at one time in their life. In fact, sometimes people don’t even know that they have it. So again, very common and most as people with a healthy immune system can clear the virus without causing too much of a problem.

Unfortunately, there are certain types of HPV that are a little bit more aggressive than others. And then there are some people who just have immune systems that are not functioning to the best of their ability. And so that puts people at a disadvantage to clear the virus. But for reasons we haven’t really understood yet. For some, HPV remains in their system and over time can cause precancerous and cancerous changes to the cells. So if it’s not caught and treated early enough, this is what can lead to cervical cancer.

Talk to us about the IMPACT study – why and how it was conducted, and what were the findings?

So Roche is committed to women’s health worldwide. There’s too many women who are dying from this preventable disease, and we’re not satisfied to accept the status quo. So we can do better. And that’s where the impact trial comes in. The impact trial was a prospective observational cervical cancer screening study of over 35,000 women aged 25 to 65 years attending routine cancer screening across the US. The objective of the study was to compare the diagnostic performance of the biomarker technology to Pap cytology for the triage of high risk HPV positive results. So it formed the basis of the FDA approval of our dual biomarker cytology test, commercially known as CINtec PLUS.

The biomarker technology involves two mutually exclusive biomarkers that should not be simultaneously present in a normal cell. So if you think of it like a traffic light. So p16 is the biomarker that’s present in cells that are in cell cycle arrest like in a red light. And Ki-67 is for cell cycle proliferation like a green light. So you would know something was up if you saw both a red light and a green light at a traffic light. And so that’s why we call it dual state. And we’ve evolved cytology to be with biomarker technology rather than simply the morphology of a cell, which can actually be sometimes objective.

So we’re still running these tests on the same sample as you would from an HPV test or a Pap test. And this study had robust data to show that when dual screen psychology is used, it enhances a detection of cervical precancer and cancer when women are identified at risk. So this is called triage. It’s better at detection than just Pap cytology by itself. So not only that, when this dual biomarker test is negative and doesn’t detect any abnormal cells, it’s actually even more reassuring than a negative Pap cytology test that this individual does not have any cervical abnormalities.

What are the clinical implications of these findings as it relates to the fight against cervical cancer?

So clinicians can be more precise when they assess someone’s risk. So having dual stain provides additional information for a clinician to make recommendations to their patients and that minimizes undertreatment or overtreatment. And so when people get an HPV test result that’s high risk, it can be really alarming. We don’t have a treatment for the HPV infection itself. And so patients were often really unsettled when I told them that we would just have to wait a year and see if their system could clear the infection. So being able to tell folks about their dual stain result could allow them to know sooner if their cells are showing signs of oncogenic transformation and they can have more immediate follow up or reassurance, but it’s okay to give their body more time to clear the infection.

Any closing thoughts?

I think I wanted to tell your audience that cervical cancer is largely a disease of disparities. Where a woman lives shouldn’t determine whether she lives or dies from cervical cancer. But that’s all too true here in the US where I live where black women die from cervical cancer at two times the rate of white women. And that’s all too true around the world. But it’s not all doom and gloom. The good news is that the elimination of cervical cancer is possible within the lifetime of today’s youngest girls according to the World Health Organization. We have the know-how and we have the tools to see widespread elimination in 2030. And that’s exciting and that’s empowering. So let’s make it happen.