HPV diagnostics is currently not very convenient, requiring patients to go to their doctor’s office for the test. Now, 10zyme founder Dr. Angela Pine wants to change that. She wants to improve access to HPV diagnostics by developing quicker, cheaper and more user-friendly tests. Angela joins Alyssa and Rachel in today’s episode as she shares the current state of HPV testing and 10zyme’s goal to create a reliable home diagnostic kit for HPV.

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10zyme: HPV Diagnostics Of The Future With Dr. Angela Pine

Gene Therapy Expert, Dr. Angela Pine, Wants To Reduce Cervical Cancer

We’re speaking to Dr. Angela Pine, who morphed from a research scientist and is focused on creating a business around at-home HPV testing. Talk a little bit about that. It is incredibly common. Most people likely don’t know they’ve ever had it. What should people know?

What people should know is HPV or Human Papillomavirus is ubiquitous. Most sexually active people will have been exposed to it at some point in their lifetimes. Right now, the standard protocol to check for cervical cancer is to do a pap smear with or without an HPV test every couple of years, depending on age and other risk factors. This is what we do in the office, but the protocols for testing have become quite onerous and confusing because there are multiple different tasks that can be taken. People have so many questions about their HPV status so something, where we can be testing people at home, might be super helpful.

For people who are trying to connect in some way their behavior to the likelihood of them getting HPV, it sounds like there shouldn’t be judgment involved everywhere. Does it have to do with any sexual behavior, choices, or using protection versus not? What should people know if they want to reduce their risk?

As I said, most people are going to be exposed at some point. It’s typically associated with sexual activity. However, there are people who have been exposed to HPV without being sexually active. Hopefully, they’re giving us the real story. In general, a healthy lifestyle, stress reduction, and avoidance of things that might alter the immune system like too much alcohol or smoking. Multiple sexual partners certainly increase the risks of exposure, but condom use is helpful to diminish this risk. However, it doesn’t obliterate it because, after all, HPV is a skin-to-skin transmission type of virus. Condom use will not fully protect since skin-to-skin contact will still be present.

 

 

We are delighted to welcome our guest, Dr. Angela Pine, who is a Research Scientist and a Founder of 10zyme and has spent a large part of her career if not all, focused on finding better solutions for women’s health. Welcome.

Thank you very much. It’s great to be here.

You had a more linear path than many of the people that we spoke to going from a career and research science into creating a company focused on women’s health. Tell us a little bit about your background, how you got interested, and how you decided to take that experience, and parlay it into creating a company.

Even though my path has been a little bit more traditional in terms of I’m a research scientist, I started off working in prostate cancer research. I went from the male side and now switched to women’s health. I always worked in the background of women’s health. I started after my undergraduate degree researching new treatments for prostate cancer and that was end-stage prostate cancer as well.

Was there a moment where you said the work that you were doing in prostate cancer related or was there a personal experience? What caused the pivot?

When I was working on prostate cancer, I work on developing gene therapy and I specialize in use in certain molecules that can be used as gene therapy. Alongside prostate cancer, I was also working on targeting the oncogene of HPV16, which was driving cervical cancer. That’s how I got into the women’s health side of things.

As a woman, things had happened in my life that made me think, “I could use what I’m doing to help more people that have been in my situation or that are going to be in other situations that they don’t know where to go or what to do.” That’s how it all came around. I started working with cervical cancer in developing therapeutics, but then COVID happened. I pivot from therapeutics to diagnostics. I started developing COVID diagnostics, but also, in the background still working on cervical cancer. That’s how it all panned out.

I get asked about HPV in my practice all the time. For our readers, HPV is a virus. It’s essentially ubiquitous. You would agree with that. We’re learning so much more about it as time goes along, but it’s related to female cancers like cervical cancer, vaginal cancers, which are much rarer, oropharyngeal cancers, particularly in men, and penile cancers. We have vaccinations to help to address this, but maybe you can speak to exactly what your focus is. Is it in testing for this? Is it therapeutic for HPV? I’m sure people would be interested.

As I said, my focus is now mostly on diagnostics. I’m developing a brand-new technology to detect high-risk types of HPV. As you said, there are many different types of HPVs. There are over 200 now and of those types, some are classed as high-risk because they are known to be positive agents that lead to cancers. There are about fifteen different high-risk HPV types. I want to be able to detect any of those high-risk types in women, predominantly, in terms of cervical cancer screening in the UK. I’m sure you’re aware, we have a cervical cancer screening program, which is fantastic. It now uses primary HPV screening to screen women for those high-risk infections.

What I want to do is develop a diagnostic that could be used in women’s homes. Taking the need to attend a doctor of surgery or practice completely out of the equation unless they test positive for high-risk HPV. That’s with the intention of getting more women through the door of even being screened for this virus that we know causes 99.8% of whole cervical cancers.

With an at-home HPV diagnostic kit, you don’t need to go to a doctor unless you test positive for high-risk HPV. Click To Tweet

I’m wondering if, in the UK, the screening for cervical cancer is as confusing as it’s become here in the US where there are multiple protocols that are acceptable for screening right now. What does that mean? Standard in the past was always women come in at a particular age with maybe particular risk factors and have a pap smear, which is a swab of the cells of the cervix. They’re looked at under a microscope and if there are changes that might be consistent with HPV, further testing is potentially indicated.

Now, with newer guidelines over the past couple of years, we are either screening women with a pap smear alone, a pap smear with an HPV test, or that viral screening for the high-risk types only, or just an HPV test, which has been slowly adopted here in the US. What’s going on in the UK that makes this different? Is it easier? Are people just doing an HPV test? The reason I bring this up is because your in-home testing is a fascinating thought since right now a pap smear has to be done by a practitioner, which is uncomfortable and it’s not cost-efficient.

In the UK, we’ve got things a little bit more clearly aligned. We have a cervical screening program, so anyone between the age of 24 and a half to 64 is called for screening. They go along to their practitioner and have the smear test as we’ve all been calling it for many years, which is the same examination, as you say, the scraping of the cells in the cervix, and then that’s sent away.

In terms of the women going for the testing, as far as we’re concerned, when we go there, we don’t know that too much has changed. What’s happening is when your sample gets sent away, what they do first is test that sample for high-risk HPV infection. Only if that sample tests positive, do they return to the same samples, so you don’t have to go back and get screened again. They look at the same sample and look at the cells. They perform what you call cytology and the pap smear. From that, they can determine if the HPV infection has persisted. It might have caused cell changes that can then lead to cervical cancer, and then provide any treatment that’s necessary.

We do have a slightly more systematic approach. It’s a little bit clearer, but still, I talk to women now, and even though they’ve gone for their screening, and still don’t know what HPV is. They don’t understand what’s going on. This is in the UK where we have a very clear system. The education isn’t there. It’s terrible to be quite frank. Kids in schools are getting vaccinated for a virus that they have absolutely no idea what it is. Boys in the UK are being vaccinated for cervical cancer and wondering why when they don’t have a cervix. I could talk for hours about the lack of education around this, but we do have a slightly better process for screening.

If we could provide an at-home test for HPV, that would help bring all countries in line with something that’s a lot more straightforward. You can screen yourself for HPV at any point and know your status, which is fundamentally what any scientist that works in cervical cancer or HPV research wants women and men to know.

If there can be an at-home test for HPV, you can screen yourself for HPV at any point and know your status. Click To Tweet

I want to confirm HPV stands for Human Papillomavirus. This is an extremely common virus. As you said, there are more than 200 strains. Some of which are low-risk and probably will never cause any issue and others which are high-risk and have oncogenic potential or they may cause some potential pre-cancerous or cancerous changes.

 

 

To build on that, describe to people who don’t know how you might get it. You said everybody’s at high risk and there are so many different kinds. What behavior or activities increases your chances or reduces your chances of contracting HPV?

The truth of the matter is everybody who has ever had sex ever in their lifetime will likely be exposed to HPV. This is a fact. It’s on the CDC website here in the US. That’s the usual. There are other ways to contract HPV. HPV can cause genital warts or other types of warts and it’s from the low-risk strains. We know there are studies where nuns have had HPV, so either those nuns are not telling us their whole story or there are other ways of contracting this. It’s mostly considered to be a sexually transmitted infection.

 

 

The question that I get in my office all the time is, “When did I contract this? Who gave it to me?” The answer is I don’t know because, again, this could be contracted at any time from the sexual debut. It’s often difficult to ascertain exactly when or from whom it was transmitted. Here’s our Hot Flash. Per the CDC, HPV, or Human Papillomavirus is so common that nearly all sexually active men and women get this virus at some point in their lives.

Again, for people who are learning about this for the first time which is lots of people around the world, are there symptoms? There are many things that women experience where they’re silent until it’s serious. You had mentioned warts which I’m sure anyone who’s had HPV is familiar with, but what are the signs and symptoms someone should be aware of? Hopefully, when we get this test in the market, they would get the results and then seek medical care.

Most people are asymptomatic until they have much more notable symptoms. Most people would not know that they’ve had HPV or that they currently have HPV other than when they come in for testing. There might be visible signs of warts or growth, but most of the time it’s microscopic changes that are occurring that we have right now either depicted on a pap smear when we look at those cervical cells under the microscope or by having an HPV test, which is very commonly done right here.

The issue that I would like to discuss with you is what we do when we get a positive at-home test. This could panic a lot of people since a watch, wait, retest, and surveillance type of recommendation is usually what’s made. What type of education will be provided after an at-home test is positive so that we don’t have mass panic?

This is why education is such a key point and something that I feel so passionately about because if we test people for something that they don’t fully understand and give them a positive result, as you say, it can create a lot of panic and worry. What we want to do is also provide an app for these people that are using this test. It’s going to have a lot of information. It’s going to link to clinicians in the UK. It will link to their NHS app and go straight to their GP surgery.

What would happen is you would then be prompted to go and attend your smear test if you do test positive. It’s been noted that only 9% of people that are screened for HPV test positive. That’s quite a small number of the people that are being tested, but if you do test positive, you would then go for your smear test where they would examine your cells.

As you said, you can have this infection without knowing that you have it. That’s what makes it quite dangerous because it can start over time to cause these changes to the cells then will lead onto becoming cervical cancer. It’s important to then go and get your cells looked at and that’s what we would prompt people to do as the next stage. In terms of our business, what we’re hoping is to increase the number of people that are knowledgeable about their HPV status and then push fewer people through the doors for actual primary HPV screening, but then more people through the doors that do need to have their cells looked at.

 

 

That’s great. Will your test be something that’s covered by insurance or in the UK by the NHS system, or is it something that is self-paid?

In the UK, we have a cervical screening program, as I said. We hope that we will get our test adopted into the program in some way, shape, or form. NHS can be a bit of a difficult beast to get that into. We have a lot of interest from different people and stakeholders. We’re hoping that it will be part of the screening program. At the moment, you can get a letter, text message, or both from the screening service telling you that you need to make your appointment.

Our vein of thinking is what you’ll have is a text message with a link saying, “Click here to order your pack,” and it’ll drop through your letter box a few days later, which takes a lot of the pain out of having to attend your smear test. We also want to explore more partnerships with healthcare diagnostic brands, and things like that. I’m sure you’re aware that decentralizing healthcare is very in vogue and it’s something that a lot of us believe needs to happen. We’ll explore those partnerships as well.

One of the things we often see in women’s health is there are challenges with diagnosing and if there is a delay in diagnosis, it can result in other more serious problems. Alyssa and Angela, could you help people understand if you have HPV and you diagnose it quickly versus you don’t diagnose it quickly, what are some of the impacts? The reason I ask that question is because we have so many people reading this who are learning about PCOS and how delayed diagnosis could have an impact on fertility. It’s the same with the length of time it takes to diagnose endometriosis. Is there a parallel here with how much more serious the symptoms can get with later diagnosis?

It’s very important to realize that most people with a healthy immune system are going to clear this infection without any repercussions, so that should be heard first and foremost. Keeping your immune status in a good place by getting enough sleep, avoiding things like tobacco, and trying to keep your stress levels low is going to help your general immune function. Therefore, help your natural processes of clearing infection to take hold. People who are immunosuppressed, who smoke, who have multiple sexual partners, and unprotected might have more risk of exposure and would be considered to be in a slightly higher risk category. Those things are things to keep in mind.

The other thing is that there are some people who have persistent HPV infection, and these are people who need heightened surveillance and further testing. I would assume these people are going to be picked up by your testing and fostered into the actual provider’s office to get further testing, but because you have an HPV-positive test doesn’t mean you’re destined for cervical cancer. It means that you may need heightened surveillance.

Another thing to keep in mind that is something reassuring to think about is that the progression of cervical cancer is very slow. Going from a positive HPV test to cancer is a very long timeline. There are loads of time to intervene where preemptive measures can be taken. That’s very important. With that said, we surely don’t want to ignore it.

Angela, as you are developing this, is there a line of sight as to when it would be available in the UK and then maybe more broadly? Our readers are global, but this is not a problem that’s unique to the British health system.

We’re at very early stages at the moment. We’re hoping that we would be able to get something out to market in the next couple of years, so that’s for the at-home test. We have some interim things that we want to do in the meantime like replacing the way that labs test for HPV and reducing the cost of that. It’s getting some cost-benefit into the healthcare system already, but I estimate maybe in a couple of years.

We’re doing HPV testing all the time in our office. What’s the difference between what you’re trying to bring to market and what we’re already doing? Is it just that it’s an at-home thing? Is it getting the app up and running with the follow-up or a little of everything?

It’s all of that. At the moment, you’re probably using one of the kits along the lines of RT-PCR, and things like that. There are a few different methods that are available. Those require specialist equipment and trained personnel. They were quite expensive as well. At least in the UK, they are. I’m sure they are everywhere else. Our test aims to get it to a point where anyone can use it at home.

 

 

It’s similar to the way we were all forming COVID tests with lateral flow. Although it isn’t lateral flow technology. I have to stress that. It’s a new technology and it’s quite important to also consider. The reason why this hasn’t happened up until now is because pre-COVID, the only things we tested for at home were pregnancy. That’s because there wasn’t much faith in at-home testing.

Governments have now seen that it has its place and it has its benefits. Still, when you are looking for a virus or something that’s a precursor to cancer, there are a lot of tapes to get through because you don’t want to give people false positives at home, especially when you’re looking for things like cancers. That’s why the new technology is required at this point because lateral flow for all its benefits during COVID just isn’t sensitive and specific enough to look for something like HPV that has a connection to cancer. That’s why we’ve developed a completely new technology that hopefully we can put into people’s homes and give them the reassurances that they need.

You don't want to give people false positives for at-home tests, especially when you're looking for things like cancers. Click To Tweet

As given your background from a researcher to now an entrepreneur, are there any tips you have for people who might be thinking about that same journey? Obviously, some of the skills are transferrable. Based on our experience, there is a whole lot that is new and required, and many surprises. Any words of wisdom to people who are thinking about making this leap?

I speak to scientists that are starting their careers or research careers quite a lot about startups or spinouts, and things like that. It’s a steep learning curve. I’ve learned so much and I’ve only been doing it for several months now. You can never get enough information. I attended a lot of things like venture builder incubators and accelerators, and they are worth their weight in gold. It’s a completely different way of thinking from being a scientist. Get as much help as you can.

One of the things that we find so affirming about this space is how many more companies are being created, entrepreneurs are being born, and investors starting to get interested in this space. Again, we always refer to the theme, “A rising tide raises all boats.” We are thrilled with the work that you’re doing. It’s exciting. It would give people another option. We always talk about this, given Alyssa’s background on all the things that she sees, how we want to make sure that these options are meant to enhance the amount of information that people have and the choices that they have, not necessarily supplant the role of the healthcare practitioner. We’ll be watching and looking forward to this product, making more progress, and coming to market so that consumers have more options.

It’s exciting times.

At-home testing is all the rage right now, so what better test to have at home than HPV? Thank you so much for your hard work. We look forward to watching your progress.

Thank you very much.

 

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