Nurse Maureen‘s Health Show

HPV Testing at Home: A Game Changer for Women

Maureen McGrath

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Unlock the future of women's healthcare with the groundbreaking HPV self-screening test, BD OnClarity HPV test promising a revolution in cervical cancer prevention. Joining me on is Dr. Casey Gardner, Senior Manager of Medical Affairs at BD Canada. Together, we unravel the complexities of HPV and its direct link to cervical cancer, while spotlighting the transformative power of this new at-home test. With traditional Pap smears often plagued by discomfort and limited accessibility, especially in remote communities, the introduction of self-screening offers a game-changing alternative that brings healthcare closer to home. The Health Canada-approved BD OnClarity HPV test, stands out for its accuracy.  This advancement could significantly increase screening participation and reduce cervical cancer incidence. Embrace the shift in women's health as we explore the substantial impact of accessible, efficient, and reliable screening options on the future of cervical cancer prevention.

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Speaker 1:

Good evening and welcome to my podcast, Nurse Maureen's Health Show podcast. It's always an honour and a pleasure to serve you with education about important healthcare issues. I'm a registered nurse, nurse, continence advisor and a sexual health educator. I work largely in women's health, but I also do bladder health and sexual health as well. I'm very excited about the topic tonight because this is an issue that I've seen in my practice and my clinical practice over the years and this is such a major advancement in women's health care. I'm so excited about it.

Speaker 1:

You've probably heard about a pap smear, a test that looks at cervical cancer through changes in the cells of the cervix. It's usually done in the doctor's office. Women aren't very excited about going into their doctor's office for a pap smear because it can be embarrassing, uncomfortable and it can be difficult to access this test because you might be working, may not have time and, yes, it's also painful, especially for women at menopause and beyond, which is one of the downsides, as I mentioned. Access is another plus. A false negative result may occur and it can be costly for further testing after an abnormal test.

Speaker 1:

In Canada, an estimated 6.3 million women age 15 and older are at risk of developing cervical cancer, with HPV human papillomavirus causing 70% of the cases. The rates of cervical cancer are also three times higher in remote and underserved communities, where pap smears are more difficult to obtain. Well, here's the good news Health Canada has approved a self-screen test for the virus that causes cervical cancer and that has the potential to eradicate cervical cancer altogether. It's a simple, reliable, at-home self-screening test, and joining me on the line to discuss this is Dr Casey Gardner, Senior Manager of Medical Affairs at BD Canada. Good evening, Dr Gardner. How are you? I'm great. Thank you very much, Maureen, for having me on. Thank you so much for joining the podcast. Let's get right to it. What is HPV or human papillomavirus, and why should we all be concerned?

Speaker 2:

Yeah. So human papillomavirus, or HPV, is a common virus that affects many different parts of your body. There are 40 types of HPV that specifically affect your genital area and they can easily spread through sexual contact. Some HPV genotypes are relatively harmless, you know, causing things like genital warts, and many of these infections will go away on their own without causing significant problems. However, there are 14 clinically relevant high genotypes and they range in their risk profile. Some are higher than others and those will ultimately have the higher potential of leading to cervical cancer. So genotype 16, 18 account for 70 percent of the invasive cervical cancer worldwide, but their prevalence is actually declining due to vaccination rates, which is kind of exciting.

Speaker 2:

So in Canada, 2006, gardasil was Health Canada approved, which is a four-valent HPV vaccine, and then in 2015, we now have access to a nine-valent HPV vaccine. So it's targeting nine different genotypes of HPV viruses. So as vaccination in our community increases, the prevalence of those higher risk genotypes will fluctuate and change over time, which is kind of interesting. So, and it's, I think, in general, really important to know that many people will have an HPV HPV infection in at some point in their life, but usually the immune system will remove it and it's not significant. It usually is removed in about two years. System will remove it and it's not significant. It usually is removed in about two years. But if they are infected with an HPV, a high risk strain, that doesn't go away, it can cause cervical cancer and changes to the cervical cells and those changes can ultimately lead to cervical cancer.

Speaker 1:

I opened with a little blurb about the PAP testing which is, you know, looking like it's going to be in the past as we move forward with HPV screening. What is the difference between a pap test and HPV screening?

Speaker 2:

Yeah, you kind of alluded to the how fun it is to get a traditional pap test and I'm sure many females in your audience are aware of how pleasant it is. But a pap test is again done in a physician's office your physician or your primary health care provider collecting cervical cancer sorry, cervical cells to check for changes in them which are ultimately caused by HPV and have the risk of developing into cervical cancer if they're left untreated. So a pap test is looking at precancerous or cancerous cells. Conversely, an HPV test is looking is testing for cells infected by the HPV virus and that's usually prior to cellular changes. So if you think about it, you're kind of picking up the potential of cervical cancer earlier on in that disease progression. So it's an earlier detection method compared to a pap test which can also ultimately lead to earlier intervention and better outcomes.

Speaker 1:

And basically catching it early, before it develops into precancerous cells or cancer of the cervix Exactly Now. Can you also walk us through how the self-screening BD on clarity HPV test works and what makes it unique compared to other HPV screening methods?

Speaker 2:

Sure, Okay, so I'll start with how it works. So if you think to self-collect at home, you would be mailed a self-collection swab which is basically a tube with a swab stick in it. Essentially, you would break the seal of that self-collection swab, pull out the attached swab of the two, insert it into your vaginal opening, rotate around for 10 to 30 seconds in your vagina and then place the swab back in the tube and so, again, this is different from a pap test where you're testing for the or your, your healthcare provider would be testing for the cervical cells. You're just you're just getting vaginal cells on the swab. So you put the swab back in the tube and then you would insert sort of the tube in the prep-packaged instructions. That would then be shipped to a lab to be analyzed and then you would be given your results either by your primary healthcare provider or directly from the lab thereafter.

Speaker 2:

So why BD on Clarity specifically, is unique in the Canadian market for two reasons it is an extended HPV test and it also allows for that section sorry, that self-collection which I just talked about at home. So I'll go into a little bit more about what extended HPV testing is. There are a couple of different kinds of HPV tests. There's a partial and extended HPV testing, so all HPV tests will cover 14 high-risk genotypes. But extended genotyping will report out more individual types and pool less of them together. So extended HPV testing, like BD on clarity, not only tells you if HPV is present but it also tells you with what specific genome type you're positive with.

Speaker 2:

And that's really important for two reasons. As I mentioned before, some genotypes have a higher probability of turning into cervical cancer. So 16, 18, 31 are much higher risk genotypes. But it's also important for something else called persistence. So if you are positive with the same genotype over time after multiple tests, even if it's not one of the higher risk strains, you have a higher probability of that turning into cervical cancer.

Speaker 2:

So I think I always think this is easiest to understand. An example so if I do a self test and I screen positive for 31 and I then test again a year later and I'm still positive for 31, my chances are a lot higher that that will develop into cervical cancer, are a lot higher that that will develop into cervical cancer versus if I screen initially and I'm positive for 31 and then say a year later I screen again and I'm now positive for 52. Even though I'm positive both times, if I didn't know the exact genotype I was positive with, I wouldn't know that now it's a different strain and it's also a lower risk strain. So it's not only important to know what you are positive with, but also that persistence of that genotype over time, and that is not only important to you as an individual but also to your physician and our public policy developers who are right now kind of generating these guidelines on HPV testing, and this will allow them to provide sort of a risk stratification approach to manage patient triaging for additional testing, diagnostic testing and subsequent teacher sorry subsequent treatment.

Speaker 2:

I've got time to buy, yeah go ahead.

Speaker 1:

That's okay. So it sounds like it's more specific, more sensitive and ultimately more accurate than other HPV screening methods. Would that be a fair statement?

Speaker 2:

Yep, that's exactly right screening methods. Would that be a fair statement? Yep.

Speaker 1:

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Speaker 1:

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Speaker 2:

did you identify? Yeah, so BD on clarity was developed a number of years ago as the science was demonstrating the link between HPV and the development of cervical cancer. It is actually, or was actually, approved in May 2021 in Europe and any countries that accept the CE mark, which is Europe's regulatory sort of stamp of approval. So it's been around in other countries for a while.

Speaker 2:

Unfortunately, north America was a little bit behind this, but sort of the idea around the self-collection at home piece was specifically prioritized at BDants of health. So hence the ability to self-collect in the privacy of your own home would allow women to be screened for cervical cancer who may otherwise not want to participate or wouldn't participate in cervical cancer screening. So maybe a woman doesn't have access to a family doctor, or they don't feel comfortable doing it at a family physician, or they don't understand the importance of screening. They could live in rural or remote areas, which is logistically and economically sometimes really challenging to get to a doctor's office to get screened. So HPV testing using self-collected vaginal samples has been shown to improve women's participation in cervical cancer screening programs, and particularly in regions with really limited access to healthcare. So, like those rural and remote areas shown to improve women's participation in cervical cancer screening programs, and particularly in regions with really limited access to health care, so like those rural and remote areas.

Speaker 1:

All of the above and I see that in my clinical practice where, you know, women put off having their pap smear because of the discomfort, especially around menopause, where estrogen stores decrease and there's dryness which can lead to significant pain. Or, you know, women are busy, busy working inside and outside of the home, it's difficult to get into the doctor's office and park and all of that. And then also, as you mentioned, the women in rural and remote areas. This is such a tremendous advancement where women can, you know, take care of their health at home a very important aspect of health. So how accurate is the self-screening test compared to traditional screening methods like the pap smear?

Speaker 2:

So HPV primary screening is more sensitive than a pap alone. And again, that's really because you're testing for the presence of HPV infection prior to those precancerous cellular changes. So again, you're catching it earlier on. Studies have reported that HPV primary screening provides 60 to 70 percent greater protection against invasive cancers when compared to sort of a conventional pap test that are used as a primary screening method. So Health Canada just approved BDs on Clarity HPV test because they looked at our clinical data and saw that it was equally comparable if myself collected the sample or any other individual in Canada versus if our primary healthcare provider collected the sample or any other individual in Canada versus if our primary health care provider collected the sample. And there's also meta-analyses that have looked at 56 test accuracy studies. But it also included 25 randomized trials that concluded that HPV assays were sensitive and specific enough when patients or individual women collected the samples themselves, compared to if your physician collected them.

Speaker 1:

And it also frees up some time in the doctor's office so that other patients can be seen, so people don't have to make an appointment for a pap test for those women who have been able to access doctors in this country. But it is also capable of detecting other high-risk HPV strains and low-risk and those throughout the years as well. So how often do women if they have a normal, if they've had a normal pap in the past and had normal HPV screens, how often must they do the HPV screening?

Speaker 2:

Yeah, that's a really important question and really good for all women to know. Currently, most provinces and territories recommend cervical screening, beginning at age 21 to about 25 and continue to age 65 to 70, occurring every two to three years. Really depends on the province for the specifics of that. Many provinces have committed or plans to implement HPV testing as their primary screening programs, but they haven't been rolled out yet, with the exception of PEI and BC, who have already implemented HPV as their primary screening methods. So a lot of these sort of screening programs and frequency between screenings or HPV tests are still being developed in terms of what is the appropriate time to be screened.

Speaker 2:

So if you think about, like the sort of diagnostic and screening programs, what happens if you have a positive test, hpv test? What is your subsequent diagnostic test? Is that a PAP? What happens if your test is negative? And then how do patients triage patients and sort of stratify based on risk? So, most likely, the recommendations for HPV tests will be similar to a pap in terms of 25 to 70 years of age and, depending on your sexual activity, but also, depending on you know, have regional differences. One potential difference that we probably will see is that and we've seen this in other countries who've adopted HPV as their primary screening method, is that the frequency of screening does decrease and generally you see about from two to three years to five years with HPV and that's again because you're testing for HPV infection which is earlier on in the sort of disease progression. So yeah, it's sort of a little bit to be determined as each province is rolled. Each province rolls out their their HPV primary screening program.

Speaker 1:

But generally for women who have had normal PAPs and normal HPV tests. It's about every five years. Yeah, Is this a reliable option for those with previously abnormal PAP results?

Speaker 2:

Yeah, definitely, and I think you know, depending on your how, how long ago you had a positive pap. Even if it was very recent, it can still be really informative to know what HPV infection or genotype you have. And again, because some of the genotypes have a higher risk of developing into cervical cancer. But then if that was sort of a past positive PAP and you've been cleared it was a false negative or there was a lower risk, that you're sort of being monitored. Hpv testing is definitely a testing modality that you can use to test thereon after.

Speaker 1:

And for those women who do their self-screening test, if their result indicates an HPV infection, what are their next steps and are there any follow-up, resources or support provided?

Speaker 2:

Yeah, so most of it will depend on your provincial guidelines. Most commonly you would probably go for a pap test at your physician's office or a colposcopy. So it will depend a little bit again what HPV you're positive with, if that's a persistence. So you've been positive with the same HPV genotype after multiple tests and probably some other personal risk. You know history of cervical cancer in your family or things like that. So it'll it depends a little bit on the specifics and your, your province that you live in.

Speaker 1:

And and finally, what impact do you hope that the BD on clarity HPV self-screening test will have on the rates of cervical cancer screening and HPV vaccination?

Speaker 2:

Yeah, as I mentioned before other countries who have sort of demonstrated an increase or have demonstrated an increase in participation in cervical cancer screening with at-home self-collection. So we really anticipate and hope that Canada's screening participation will increase with this. Cervical cancer is one of those few cancers that is completely preventable through systematic screening programs, early detection with HPV tests and vaccination programs, early detection with HPV tests and vaccination and unfortunately, cervical cancer diagnosis I think you said this in your intro in Canada has increased 3.7% since 2005, aftera 30-year decline kind of beginning in the mid-1980s, and recent estimates show that 25 to 40% of eligible Canadians, canadian women, are not routinely screened. So there's ample evidence to show that underscreened women or never screened women have a higher incidence of cervical cancer and are diagnosed with more advanced disease, and that's true for breast cancer as well. So it's anticipated that participation in cervical cancer screening programs will increase with self-collection at home, which is awesome and it's so great for women.

Speaker 1:

I love to see any advancements in women's health because, you know, oftentimes women feel that they're dismissed or underserved. The research doesn't equal the research that has been done for men, and so this is just a tremendous accomplishment for BD Canada. Thank you so much for joining the podcast this evening, dr Gardner. Thank you very much for having me. It was a pleasure. So much for joining the podcast this evening, dr Gardner. Thank you very much for having me. It was a pleasure.

Speaker 1:

And if you're listening right now and you have not had a pap smear, or if you have not been able to have access to one or you just have delayed it, know that there now are HPV at-home tests that'll be coming to this country very soon, that you can do this in the comfort of your own home and do it yourself. It's much less painful, far more accessible and much more sensitive, specific and accurate. If you know anybody that would benefit from tuning into this episode, please share this episode with them. And that was Dr Casey Gardner, and she is Senior Manager of Medical Affairs at BD Canada and we were talking about the BD on clarity tests for the HPV virus. I'm Maureen McGrath. Thank you so much for tuning in to this episode of my podcast. Thanks so much for tuning in. I'm Maureen McGrath and you have been listening to the Sunday Night Health Show podcast. If you want to hear this podcast or any other segment again, feel free to go to iTunes, spotify or Google Play or wherever you listen to your favorite podcasts. You can always email me nursetalk at hotmailcom or text the show 604-765-9287. That's 604-765-9287. Or head on over to my website for more information. Maureenmcgrathcom, it's been my pleasure to spend this time with you.

Speaker 1:

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