Expanding Access: Self-Collected HPV Testing

Podcast Transcript

Dale Shepard, MD, PhD: Cancer Advances, a Cleveland Clinic podcast for medical professionals exploring the latest innovative research and clinical advances in the field of oncology.

Thank you for joining us for another episode of Cancer Advances. I'm your host, Dr. Dale Shepard, a Medical Oncologist, Director of International Programs for the Cancer Institute and Co-Director of the Sarcoma Program at Cleveland Clinic.

Today, I'm happy to be joined by Dr. Sudha Amarnath, a Radiation Oncologist and Co-Director of the Gynecologic Cancer Program. She was previously guest on this podcast to discuss improving the quality of care for patients with cervical cancer, and that episode is still available for you to listen to. Today, she's here to talk about self-collected HPV tests that could revolutionize cervical cancer screening. So welcome back.

Sudha Amarnath, MD: Thank you. Thanks for having me.

Dale Shepard, MD, PhD: Absolutely. So give us an idea again, what you do here at Cleveland Clinic.

Sudha Amarnath, MD: Yeah, so my kind of official role is as a radiation oncologist and I primarily treat gynecologic cancers, which very much includes women with cervical cancers, vaginal cancers, and vulvar cancers, which is of course why I'm here today because those are all cancers that are primarily HPV-driven. I also treat a lot of anal cancers, wearing another hat as a colorectal radiation oncologist, and those are also HPV-driven tumors. So HPV, or human papillomavirus, is a big part of what I think about on a daily basis.

So, as a radiation oncologist, I tend to take care of patients who have more advanced disease and require more advanced treatments to get rid of their cancer. And so anything that we can do to detect cancers earlier or prevent cancers from happening is something that I always like to see. And that's what we're here to talk about today.

Dale Shepard, MD, PhD: That's what we're going to talk about. When we talk about HPV and cancer risk, and we talk about cervical cancer, a lot of different people might be listening in and people kind of know a little bit about it, but remind us why HPV is important, and how it's been traditionally tested for.

Sudha Amarnath, MD: Yeah, so HPV, or human papillomavirus, is just a really common virus that is in our general population. One of my gynecologic oncology colleagues, Dr. Buffa, actually calls it the common cold for the vagina, because literally anyone who has been sexually active in their lifetime is going to be exposed to HPV. And for some reason, most people clear the virus with just their normal immune system, but in some patients it just kind of lingers, and it doesn't clear, and then that virus can basically cause changes in the DNA, which lead to cancer over time.

So a lot of the patients that we see with HPV-related tumors, it wasn't something that they were exposed to a year before, a couple of years before. Oftentimes it was even 10, 15 years prior to their diagnosis, because it can take time for the HPV to cause those cancer changes.

Dale Shepard, MD, PhD: Traditionally, how do we look for HPV?

Sudha Amarnath, MD: Yeah, so traditionally patients would go to their gynecologist, sometimes their primary care doctor. Everyone kind of dreads the visit, where you have to get undressed, get into a gown, put your legs in stirrups, and then the doctor would put in the dreaded speculum, and ultimately do a swab on the cervix to test for just abnormal cancer cells. And that was called a pap smear. And so that's kind of been around for a very long time. And then in more recent years, HPV testing became available, which is still tested for similarly, where they swab the cervix for those cells and then send it off to a lab and basically the lab can test for the human papillomavirus being present.

So that's what we've done for many years, and it's a very good test, but sometimes women don't have access to that kind of testing, and that's why some of what we're talking about today is going to make a huge difference.

Dale Shepard, MD, PhD: Yeah. And so I guess what we're talking about is self-collected HPV tests. So give us a little bit of background about what that's all about.

Sudha Amarnath, MD: Yeah, so self-collected HPV tests are basically kind of what it sounds like. I kind of like to analogize it to a Cologuard test. So instead of a colonoscopy, where they're putting a scope up into the anorectal and colon area to look around, you leave a stool sample, they send it off to a lab, and then they can test for changes that might show if you're at risk for having cancer or might have a cancer.

So same thing here. Instead of going to have a full speculum exam or pelvic exam with a provider, you use a swab yourself to actually get inserted into the vagina, and it takes a little bit of a sample of those same cells that your doctor would test for, and sends it off to a lab, and it looks for the same changes that your doctor would be looking for when they do an exam.

Dale Shepard, MD, PhD: Now this has been used here for a while, but it's been more common in places like Canada and Europe?

Sudha Amarnath, MD: Yeah, so it's been approved in many other countries now for a number of years. So a lot of Northern Europe, Canada, Australia use this much more routinely. It just became FDA approved in the US this past year. I believe it was May or June of 2024. Initial approval was just in the healthcare setting. So basically you would go to see your doctor, it doesn't have to be a gynecologist, it could be a primary care doctor or just another physician visit, and they would be able to give you the kit. You go into a private space like a bathroom. They give you instructions as to how to use the kit, and then you could take your own sample privately, and then you give it back to the healthcare provider to send off to the lab.

So that's what was FDA approved. Up until most recently, there was approval for an at-home test. So just like Cologuard, where you can do it in the privacy of your own home, the at-home testing allows women to actually do this test at home and send it off without even having to see a healthcare provider in the office.

Dale Shepard, MD, PhD: Yeah, that's fantastic. Why do you think there was a delay in getting that here in the US compared to other countries?

Sudha Amarnath, MD: That's a good question. I think in general, the US has had very rigorous kind of guidelines on what they approve through the FDA. So typically it requires a lot of testing, clinical trials that are comparing the test to our gold standard of care. And so it just has taken more time to get that data accumulated, but now we're here.

Dale Shepard, MD, PhD: There we go. It seems like this is something that patients would be enthusiastic about, they'd be much more willing to do. Do you think it was more of a pushback from providers who were skeptical that not the way it's always been done?

Sudha Amarnath, MD: I think that's always a challenge in healthcare. It's hard to convince people when we've been doing things the same way for a very long period of time, but I think the reality is, is that almost 30% of women don't get screened as they should. And especially in places where there is not a lot of access to healthcare, kind of so-called healthcare deserts, or for women who have history of past trauma, or just have other medical issues that might get in the way of wanting to go in and get routine screening, this makes a really big difference to be able to get those women the care that they need.

Dale Shepard, MD, PhD: Yeah. Do you think this is going to end up being something like... your colorectal hat. Oftentimes a colonoscopy is fantastic. You can actually see things, you can make assessments, and the Cologuard is great for people who don't want to do, or won't do a colonoscopy, and any screening is better than no screening at all. Do you think we'll still have a lot of people that might still do the traditional screening, and then will catch that group that doesn't want to do the traditional screening? Or do you think ultimately this is going to be something where virtually everyone does self-testing?

Sudha Amarnath, MD: Yes, that's a really good question. I think that ultimately you're going to have a lot of women who didn't have good access, who are going to be able to collect on their own. And I think just to go back to that Cologuard analogy, if a Cologuard test comes back positive, those patients go on to get a colonoscopy.

Dale Shepard, MD, PhD: Correct.

Sudha Amarnath, MD: That's very important. And so same with the self-collection. If the HPV test comes back positive on a self-collection kit, those patients do need to see a healthcare provider for further testing and for further evaluation. So I think mostly it's giving people who didn't previously have access, more access to a test that they need.

I can say from my own perspective as a female, that if someone gave me the option to do a self-collection test, and I didn't have to miss work to get to a gynecology appointment and whatnot it's-

Dale Shepard, MD, PhD: Yeah, tempting.

Sudha Amarnath, MD: It's very tempting, yeah. And I think that there are things on the exam that clinicians, they can feel for abnormal lumps and bumps, and there are other things that we learn from the history and actually talking to patients. So nothing really replaces seeing a clinician, but again, if we can, especially, get to patients who have not seen a healthcare provider in a long time, especially a gynecologist, and we can get them tested, that's a big deal.

A lot of the patients that I see who have cervical cancer are patients who were just putting other people in their life ahead of them, and so they were not getting as much of the routine kind of healthcare that they would need to have. So many of the patients I have seen have not had screenings for 5, 10, 15, 20 years, and if this makes that possible, and we prevent even one more woman from getting cancer, that's a good thing.

Dale Shepard, MD, PhD: Yeah. And we know that HPV detection is important because with the vaccine, we've been able to reduce the numbers significantly.

Sudha Amarnath, MD: Absolutely. And I think the other part of this is that it just brings more visibility to HPV, and hopefully that will also get more people, especially young people, to get vaccinated because they'll better understand the connection between HPV and cancer. I don't know that we've always done the best job of educating people about that connection and the importance of the vaccine at a young age, because really, these cancers, as I mentioned, you have cervical cancer, vaginal cancers, vulvar cancer, anal cancers, as well as head and neck cancers. All of these are preventable with the vaccine.

Dale Shepard, MD, PhD: Yeah. If we think about, I guess, when people don't do screenings, you talked about people being busy and having other obligations, the others, of course, financial, in places where this is available, are there ways to get patients that have financial barriers access to these tests?

Sudha Amarnath, MD: It's a great question. And again, I don't know what the insurance piece is going to look like or what the out-of-pocket cost is going to look like. I tried to look this up before we had this episode and because-

Dale Shepard, MD, PhD: Hot off the press information.

Sudha Amarnath, MD: But I think the hope with this self-testing and these companies that are creating these products is ultimately to make it more accessible. So I would hope that even if it was out-of-pocket for people who are uninsured or underinsured, it's going to be at a price point that is accessible for those people.

Dale Shepard, MD, PhD: Well, certainly, like you said, this is a preventable cancer in many cases, and so doing the testing, trying to minimize risk is really, really important.

Sudha Amarnath, MD: Yeah, absolutely.

Dale Shepard, MD, PhD: I appreciate all your insights today.

Sudha Amarnath, MD: Thanks for having me. I'm excited for all the women that hopefully we can help with this new testing.

Dale Shepard, MD, PhD: To make a direct online referral to our Cancer Institute, complete our online cancer patient referral form by visiting clevelandclinic.org/cancerpatientreferrals. You will receive confirmation once the appointment is scheduled.

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