HPV Self-Collection for Cervical Cancer: Dr. Kay’s Insights

In this episode of OncoDaily, Dr. Carolyn Kay, MD, an obstetrician-gynecologist and Global Medical Affairs Lead at Roche Diagnostics, joins host Emma Ter-Azaryan to discuss the FDA-approved HPV self-collection solution. Dr. Kay explores how this groundbreaking approach enhances access to cervical cancer screening, particularly for underserved communities. She highlights its accuracy, reliability, and potential to overcome barriers such as geographic limitations, cultural concerns, and personal experiences.

Carolyn Kay, MD, is an obstetrician-gynecologist with a focus on cervical pre-cancer and cancer, racial disparities in cervical cancer screening, reproductive health, and the use of digital technology to address unmet needs in women’s health. As the global medical affairs lead supporting oncology assays at Roche Diagnostics, she is a contributor to the global movement to eliminate cervical cancer while working to move the needle on physician education and health literacy in historically excluded communities.

Dr. Kay earned her medical degree at the SUNY Upstate Medical University and completed residency training at Hofstra-Northwell Health in New York.

00:00 Introduction
02:32 HPV Self-Collection Explained
05:22 HPV Self-Collection & Accessibility
07:15 HPV Self-Collection Process & Accuracy
08:55 HPV Self-Collection: Clinical Data & Effectiveness
11:00 Addressing Doubts in HPV Screening
12:17 HPV Self-Collection vs. Traditional Tests
13:50 Cancer Screenings for Underserved Communities
15:10 Encouraging HPV Self-Collection Screening

Emma Ter-Azaryan: Hi everyone, welcome to OncoDaily. I’m your host for today. My name is Emma Ter-Azaryan, and today we will be talking about HPV self-collection solution, and I’m very excited to introduce our guest for today, Dr. Caroline Kay. Thank you so much for being with us today.

Caroline Kay: Thank you for having me. It’s nice to be with you.

So before we start, I would like to briefly introduce Dr. Caroline Kay. Dr. Caroline Kay is an obstetrician gynecologist with a focus on cervical pre-cancer and cancer, as well as use of digital technology to address unmet needs of women’s health and cervical cancer screening and reproductive health. As the medical affairs lead, who’s supporting oncology assays at Roche Diagnostics, Dr. Kay is a contributor to the global movement to eliminate cervical cancer, as well as helping physicians to move the needle on physician education and health literacy in historically excluded communities.

Dr. Kay received her medical degree at SUNY Upstate Medical University and completed her residency at Hofstra Northwell Health at New York. Thank you so much for being here.

Caroline Kay: Thank you, glad to be here with you.

Emma Ter-Azaryan: The first question that I would like to ask, as we know recently, HPV self-collection solution was approved by the FDA. To begin with, I would like to ask, could you please explain what the HPV self-collection solution is, how it works, and what makes it a significant advancement in cervical cancer screening?

Caroline Kay: So this is a really exciting development in the world of cervical cancer screening. Traditionally, women and individuals with a cervix will go to their doctor to get cervical screening where they get a PAP test. And this usually involves putting their feet in stirrups and getting a pelvic exam so that their doctor can obtain cervical cells.

Those cells are then taken to the lab and they’re looked at in the microscope to see if there’s any abnormalities. In addition, there’s another test that can be performed also at the same time. And that’s a test that looks to detect whether there are certain high-risk types of HPV present, because this is the main risk driver for cervical cancer.

And then after that, there’s also another test if women test positive for the high-risk HPV to get dual-stain cytology. And then in some cases, if they’re very high-risk, they would go directly to something called colposcopy where the cervix is examined under a high-powered scope. So with HPV self-collection, what is really a new development is that women and people with a cervix can collect their own vaginal samples privately and under their control in a healthcare setting.

There are some different devices that are in use. So one looks like a very long Q-tip. And then there’s another one that has a long, flexible bristles.

And so then they would, under their own control, maybe like in the bathroom of their clinic, insert the device about three inches into the vagina, and then follow the packaging directions or the instructions from someone who’s trained in collection. And then that person would take that sample, put it in a preservative solution, and then bring it to the lab under controlled conditions for testing. And then after that, it would follow the same way.

It would be tested as if a clinician had collected it.

Emma Ter-Azaryan: Thank you so much. So it seems like the HPV self-collection solution is offering a great alternative for traditional ways to detect HPV. So I would like to ask for those people who face different barriers, such as geographical or maybe cultural challenges, as well as they maybe experience some traumatic experiences.

For those type of people, I would like to generally ask who can take the test and how it helps increase the access for underserved populations.

Caroline Kay: Yeah, so as you can imagine, we live in a world that’s not perfect. And our healthcare system is not perfect. And sometimes it’s very hard for people to access our healthcare system.

And so this HPV self-collection offers an alternative to women and people with a cervix when these traditional screening options don’t really work for them. And this allows people to collect the samples privately in the healthcare setting, potentially without a speculum if they have aversions to this kind of exam. We know that more than half of all cervical cancer patients are underscreened.

And new cervical cancer cases come from people who are underscreened or unscreened. And so it’s really important to help decrease that barrier to getting screening in the first place. And so we believe that HPV self-collection is one of the first steps that we can make cervical cancer screening more accessible to these populations.

And so, you know, folks who are interested and desire self-collection can request that from their clinician and have that opportunity to take it from various healthcare settings, such as an urgent care clinic or a retail care clinic or in their doctor’s office. And so this brings the test closer to the patient.

Emma Ter-Azaryan: So you kind of a little bit talked about it in the first question as well. But still, I would like to ask you to walk us through how the process goes on, like from the very first moment from start to finish. How does the experience look like?

And how does it ensure the reliability and accuracy?

Caroline Kay: So this is a very patient-centric solution, and it’s giving control back to the patient. So what we would imagine in most cases is that a person would request the test or the test would be offered. And once someone would agree to have the self-collection test, they would be given either paper instructions, so there’s actual pictures of how to perform it.

And then they can also get verbal instructions from a healthcare worker in their clinician’s office. And then they would go to a private area designated to take the self-collection. Oftentimes this would be like a clinic bathroom.

And depending on the particular device that is used, as I said, there’s two that can be used. It’s a long, what looks like a long cotton swab. And then the other one is like a little brush with some bristles.

You would take that out of the packaging and then put that, you would insert that about three to four inches into the vagina and follow the manufacturer’s instructions to take the sample. And then once the sample taking is completed, you’d put it back into the tube and then hand that off to the clinician or the healthcare worker.

Emma Ter-Azaryan: So I would like to ask, are there any clinical data or any studies about HPV collection solution, about its effectiveness in detecting the high-risk HPV strains?

Caroline Kay: Yeah. So most of the studies looked at comparing self-collection with clinician collection, right? They wanted to see, does self-collection kind of get very close to how clinicians are collecting?

Does the accuracy get very close and perform as well as if it had been taken by a clinician? And there’ve been many studies on this from all over the world in different populations. And those studies consistently show that self-collection comes very, very close to clinician collected.

We say that it’s pretty much comparable to clinician collected samples. And so I think it’s good to know that you can trust those results that we’ve seen consistently. In addition, one of the questions that we get a lot is, how can we trust these results?

And as I said, there’s been many studies to show that this is very comparable to clinician collected, but also that these tests have what’s called an internal cellular control. So this is an indicator on the test that is built into the test that shows whether we’ve collected sufficient cells. And once we know that we have sufficient cells, that we can trust that result to be accurate.

And so there’s some safety features in mind that are built in that help us trust the reliability of this test.

Emma Ter-Azaryan: So as we know, a lot of times people may think that it will be hard to do or how can you ensure difficulties that they face in that type of field? Like let’s say maybe they will have doubts and how can Roche address it and how can you support ensuring that they take the sample that they need, which will help you detect this, do your screening?

Caroline Kay: Well, I think it’s important to know that women and people with cervix can be confident in their ability to take their own sample safely and correctly, and they can trust that result. There have been several studies that show that people are able to take the sample correctly. As I said before, we have, there’s a built-in internal cellular control.

And this test is also done in the healthcare setting. So there are healthcare workers available on hand to help with directions or with troubleshooting, and they can assist with making sure that a quality sample is taken. And in the test packaging as well, there are how-to instructions and steps to show how you can collect the sample for either collection device.

Emma Ter-Azaryan: Thank you so much. And also, while talking about HPV self-collection solution, if we compare it to traditional screening tests like pap smear or other HPV tests, do you see the HPV self-collection solution test having the ability to replace or complementing other tests?

Caroline Kay: I think that’s a really great question. And the self-collection solution, as it currently stands, is intended in a healthcare setting for people who cannot get a pelvic exam, or are not able to get a pelvic exam for whatever the reason might be.

And there are many reasons, right?

I think we can appreciate sometimes how uncomfortable and sometimes painful for some people, definitely embarrassing a speculum exam can be. But it’s not intended to replace a pelvic exam. So people who still would like to have a traditional examination from a physician or have symptoms that warrant a pelvic exam absolutely should continue to get that care, that specialized examination from their clinician.

But for those who really are in the screening population, they don’t have any symptoms, they’re really adverse to getting a pelvic exam, this could be another alternative that is available to them and to discuss with their clinician.

Emma Ter-Azaryan: Thank you so much. So moving ahead, I would like to ask you, besides the HPV self-collection solution, what other tests there are that you see, like other diagnostic innovations that could further transform cancer screenings? And I’m talking about particularly in cancers affecting more underserved communities.

Caroline Kay: I think the key is that we want to bring the test closer and closer to patients so that they can overcome many of these barriers that people face. And so I think where we might see future innovations, I think certainly to make a test that is not required to be in a healthcare setting, perhaps we could make it closer to patients like at home or, you know, locations of their choosing at their time, we may see that.

And maybe we’ll be also seeing tests that can tell us more than just an HPV result.

Perhaps there’s more information that we could get from that swab. And we know that the National Cancer Institute is currently examining the efficacy of at-home screening in the US. And so we’ll see that more and more in the future coming down the pipe.

Emma Ter-Azaryan: Thank you. And lastly, I would like to ask you that for people who are hesitant about this new accessible option for screening, what would be your message to encourage them to take care of their health, to do the screening?

Caroline Kay: So we know in this in 2025, that the elimination of cervical cancer is possible if we can get people screened and vaccinated. That’s not always easy, but we do have the tools. And so it’s important for us to make sure to continue to provide those tools as an industry, as a company, but also to educate the public to make sure that, you know, cervical cancer is highly preventable with screening and vaccination and that there’s no need to, there’s no need for women to die from it anymore.

Also, that HPV is very common, that about 80% of people can have the virus, but they clear it and that there’s really no shame in having HPV. And so get tested, get it detected and talk to your clinician to see if self-collection is an option for you.

Emma Ter-Azaryan: Thank you so much. It was really inspiring to hear about this new way to do the screening and really looking forward to do other interviews and to share more innovations that Roche Diagnostics does. And thank you so much and take care.