Vaginal Microbiome with Evvy | Longevity Optimization Podcast

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Today I'm speaking with Pita Navarro from EVVY on the Longevity Optimization Podcast. In this conversation, we delve into the complexities of the vaginal microbiome and its crucial role in women’s health. Pita discusses the prevalence of vaginitis, the impact of the vaginal microbiome on fertility, and the importance of understanding and optimizing vaginal health through advanced testing and treatment. We also explore lifestyle factors that influence vaginal health and highlight the urgent need for more research and education in this field. The episode looks ahead to the future of vaginal microbiome testing and how it can empower women to take control of their reproductive wellness.

EVVY is a pioneering company dedicated to advancing women’s health through innovative vaginal microbiome testing and personalized treatment solutions. By combining cutting-edge technology with scientific research, EVVY aims to provide women with accurate insights into their vaginal health, enabling early detection and effective management of conditions like vaginitis. The company focuses on empowering women with knowledge and tools to optimize their reproductive wellness and improve overall quality of life.

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Timestamps

00:00 Introduction to Vaginal Microbiome

03:09 Understanding Vaginitis and Its Impact

05:56 The Role of the Vaginal Microbiome in Women's Health

08:53 Testing and Treatment Innovations

12:05 The Importance of Data in Women's Health

15:03 Challenges in Current Medical Practices

17:49 Future Directions in Vaginal Microbiome Research

21:02 Lifestyle Factors Affecting Vaginal Health

23:59 Community Engagement and Research Contributions

27:09 Conclusion

Transcript

KAYLA BARNES-LENTZ (00:00.096)

P, I'm so excited to have you here today. We're going to be talking about all things vaginal microbiome, which I think is probably one of the most interesting topics to cover. So yeah, I would love to hear a little bit about your background and how you got involved with Evy. I can't wait to dive into all things vaginal microbiome testing.

today. Yeah, well, first of all, thank you so much for having me. I have been a listener of your podcast and think the work you're doing is incredibly important, especially making all the information, which is what we try to do at EVI accessible and understandable to women after all of the testing that you do. So thank you. Yeah, I'm happy to have been so I am a molecular biologist by background. So I stayed in academic research world until there was really interesting papers coming out around 2011 2012.

in computer vision. And so I was really interested in how can we leverage this technology for diagnostics for blood testing? Like what can we image in the blood that we can create at home diagnostics? And that was my first view into the startup world, into the biotech startup world. And I was absolutely fascinated by bringing really novel technology into everyday care or patients' homes. And so I was at that startup for about four years.

And we crewed the company a lot and I was more interested in building more scientific into tools rather than software that would connect patients to doctors. I wanted to add more different types of blood tests. And that's when I left and I started researching. really, my North Star has always been to empower women through health and health education. And so I started digging into, how can I leverage these skills that I have built from taking something so novel into the patient homes for women and started talking to a lot of

patients, a lot of women on, what is your biggest frustration? Talking to a lot of doctors on like, where do you feel like you don't you lack, you know, information or diagnostics or tools. And vaginitis kept coming up. And I was so surprised at the rate from a patient perspective, you know, they were so frustrated by the recurrence. So they would go to the doctor, they would get treated. And three months later, it would come back or and from a doctor's perspective, they were also extremely frustrated by these patients because

PITA NAVARRO (02:13.912)

there wasn't any novel treatments invented since 1980s we've been treating women with the same broad spectrum antibiotics. And so to me, it seemed like a really interesting problem to approach from a prevalence and also how bad the standard of care was knowing that we were at the level of sequencing, know, tumors and cancer to create really precise treatments. Why was vaginitis so poorly diagnosed and, and treated? And not only was it very prevalent condition that women were experiencing every day.

But I also started reading about all of the amazing papers coming out, pointing to the vaginal microbiome's role in these broader health outcomes like cervical cancer progression, STI acquisition. And so that kind of really got me extremely interested in the vaginal microbiome as a really powerful tool in female biomarker discovery. And so that's when we set out to build this data set. And I met my co-founders. We all immediately quit our...

jobs when we found out that women weren't required in clinical research until 1993. And we started thinking, you know, this is a massive opportunity for us to start understanding what are all of those signals that the female body is constantly giving off that we have completely ignored in our definitions of health and disease. And the vaginal microbiome seemed like the perfect place to start. It was also interesting to us because we wanted to gather a data set across the lifespan of women. I think a lot of data sets focus on fertility or menopause.

And leveraging the vaginal microbiome to start would also allow us to understand women from 18 all the way to, think, our oldest customer is 96. And so we started by helping women with vaginitis. And now we're starting to do really interesting research on the conditions where the vaginal microbiome plays a role.

I absolutely love that and have so many questions. Okay, so first of all, what is vaginitis for anyone that is listening that might not know?

PITA NAVARRO (04:06.742)

Yeah, vaginitis is what we experience as bacterial vaginosis or vaginal symptoms, yeast infections. So it's a dysbiosis of the bacteria in your vagina. A lot of us are used to hearing the word dysbiosis in the gut. And so you also experience that in the vagina. And it's usually manifest in the symptoms where we go to the doctor and we'll get an antibiotic or an antifungal. And you see a decrease in the protective bacteria. So we have a bacteria called lactobacilli.

And as long as you're dominated by this bacteria, you're less likely to experience these symptoms. These bacteria produce lactic acid. They're truly protecting the vaginal epithelial cell wall. And they're also protecting pathogens from going upstream and causing havoc. And so the minute you start having a decrease in that lactobacilli and an increase in pathogenic bacteria, you experience that dysbiosis, which leads to vaginitis.

I mean, it's wild. do so much testing, right? And I do gut testing and really diving deep. And even I have not done, you know, vaginal microbiome testing. We have to get me one because I feel like I would love to test one. Oh, great. All right, great. I can't wait to get it. I really feel like this needs to be included, just like we're looking at our cardiovascular biomarkers and looking at nutrient status and looking at GI and, you know, trying to optimize all of these different markers.

tests all the time.

KAYLA BARNES-LENTZ (05:28.512)

we should definitely be as women optimizing vaginal microbiome health. So I'm so excited you guys are doing this. It's, you know, I've been very blessed. I don't know if it's because it's related to my level of health status. I don't know if it's genetic, but I don't really suffer from any yeast infections or even UTIs, anything of that nature. So, but I've heard that they're very common, right? Can you give us some information on some of the stats?

Yeah, definitely. So the prevalence of BV alone, not even yeast infections, is 30%. So at any given time, 30 % of women are experiencing vaginitis, BV, and that's symptomatic. The interesting thing there is 80 % of dysbiosis is actually asymptomatic. And the reason why that matters is that dysbiosis, regardless of it being symptomatic or asymptomatic, is linked to what we see as long-term health outcomes like preterm birth,

HPV persistence. So once you have dysbiosis, it essentially ripples down to causing inflammation. Your immune barrier in the vagina is essentially disrupted. And so although you, the importance of testing is because although you might be asymptomatic, if there is a dysbiosis and you're going through your fertility journey or you're going through any other transitions in your life, it's incredibly important to understand what are these.

bacteria that you find in the vaginal microbiome contributing to. But I remember the first paper that we read that got us totally hooked on the vaginal microbiome was a paper, and it wasn't a random control trial, but it said that using the just looking at the bacteria present in the vaginal microbiome, the study predicted whether IVF was going to work or not with 94 % accuracy. And so that is just, you know, some signal of the bacteria are clearly playing a role in

all of these other outcomes that we're not necessarily paying attention to. And your vagina is so accessible, right? It's even easier than gut microbiome testing. We should definitely be loved as a marker for our health and disease.

KAYLA BARNES-LENTZ (07:32.948)

Absolutely. And how many bacterias are there in the vaginal microbiome? We know that there's like countless, right? think trillions in the gut microbiome. So essentially you're never going to see a perfect gut test. You can see really good gut tests. I've gotten incredibly good gut tests, but because of the sheer amount of bacteria in the gut, there will always be some interplay of those bacteria. What is the vaginal microbiome look like?

like? Yeah, great question. So I think the vaginal microbiome is a lot more clinically translational. Like you said, in the gut, the more diverse bacteria you have, the better off you are theoretically, because you have more function protecting you from all these different types of bacteria. But in the vaginal microbiome is actually the opposite. A healthy vaginal microbiome is dominated by one species by lactobacilli. so you essentially can reach

an optimal vaginal microbiome, as long as you're dominated by one bacteria. That makes it also easier to start drawing correlations between the microbiome and outcomes to where in the gut you have so many different types of bacteria, it's hard to say which one is specifically linked to a reduction in any sort of condition. And so it's a lot easier to understand the differences between a healthy one and a suboptimal one.

Yeah, definitely. So what are we seeing is decreasing the amount of healthy bacteria in the vagina? Are there a few things? mean, does like lifestyle factors like poor sleep and exercise and nutrition, or is it really only related to like intercourse and things of that nature?

Yeah, no, the vaginal microbiome is really related to a lot of things in health. think it's very sensitive to hormonal changes. And so we a lot, for example, it's our data set is very predictive of someone being in menopause or not, because the healthy bacteria use glycogen as an energy source and estrogen produces glycogen. so fluctuations in your hormonal system can cause dysbiosis if you have

PITA NAVARRO (09:38.604)

long periods, we see, we hear women with copper IUDs that experience prolonged bleeding. They tend to have dysbiosis because the pH of menstrual blood is a lot higher than what you're supposed to have in your vagina. And so that pH basically makes it easy for pathogens to thrive. But there's hormones, definitely sex. I always like to tell women, know, there's not

There's not a paper that points to like diet specifically affects the vaginal microbiome, but it's systemic immunity. If you have inflammation in a lot of parts of your body, you're very likely to have inflammation in your vaginal microbiome.

Yeah, that makes a lot of sense. it's just, you know, I'm really like on this investigative kind of journey here, figuring out, just trying to figure out or get more answers about the issues with fertility. We know that the microplastics and the, you know, all the environmental toxins are a contributor to that. You know, it sounds like this potentially dysregulated vaginal microbiome could be, you know, contributing to that as well. So it just, it's such a pressing issue of our time and specifically, you know, for women.

because we really bear the brunt of that, even though it's a 50-50 contribution, women are really bearing the emotional stress related to infertility. So just trying to overturn every stone here.

Yes, definitely. mean, we are doing a lot of research into fertility and the vaginal microbiome's link. There is already papers across all different types of populations and geographies pointing to a dysbiosis in the vaginal microbiome has been linked to preterm birth, it has been linked to IVF failure, it has even been linked to like lower rates of natural conception. So across the getting pregnant,

PITA NAVARRO (11:23.598)

and then into like a healthy pregnancy and postpartum, the vaginal microbiome has an established link. And so what we're trying to understand is how can we go from saying dysbiosis leads to these outcomes to like very specific markers of like, what are we seeing that we can then actually target these markers and reduce the risk that we're seeing. But even for it even affects like sperm motility, right? Like if you have the microbiome becomes less hospitable to

to sperm, then you probably won't get pregnant. from, you know, assisted reproductive technologies all the way to natural conception, we know that an optimized vaginal microbiome could be linked to better outcomes.

And what are some of the, so kind of walk me through the process. You get the test, you, how is it taken? Is it a swab, vaginal swab?

Yeah, so you order the test from our website. On the back end, we have a doctor approve your order, send it to our lab, and you receive the test kit. It's a very easy 20 second swab. It's like a Q-tip for your vagina. And you send it back to our lab, and we do whole genome sequencing on the samples.

amazing. And then you get your results back in like a couple days, couple of weeks.

PITA NAVARRO (12:34.038)

Yeah, you fill out a health history. So we ask you about your period or if you're at menopause, your hormone data, any information that could help us better understand the microbiome in the context of what you're going through or what you want to learn. And then if you do have a vaginal microbiome that is in a state of dysbiosis, we also offer a precision treatment. And so we have doctors that are able to look at your results, look at your health history and say, we recommend using this treatment.

Okay, you must have really put these doctors through a lot of additional education though, right? Because I don't think they were initially taught about what treatments are for. And we'll talk about like, what is the standard of care right now? Because definitely I think people having issues, you know, with their vaginal microbiome or persistent yeast infections or things like BV, to my knowledge in the Western medicine system, they're not giving you a vaginal microbiome test. So did you do like additional training or how did you find all these doctors that are, you know,

educated on treating it in that way.

Yeah, so we didn't initially launch with care. We really wanted to understand how can we leverage our data to start improving our understanding because there is a reason why the standard of care is so important. No one has really studied it. So we didn't go out and say, we can test and treat you. In the first two years, we were gathering all of this data and we were trying to understand all of these women would go to the doctor and they would be diagnosed with something so oversimplified as BV.

And then they would, the doctor would give a broad spectrum antibiotic and there's a 50 % chance that that person gets the infection again in three months. And so we said, what can we learn from the microbiome and a health history that would allow us to stratify these patients into much more specific groups based on what bacteria is there? What could they potentially be producing? Is there a biofilm that we need to think about when treating? Is this person, is there any hormonal aspects where we can potentially address in order to actually optimize the vaginal microbiome?

PITA NAVARRO (14:33.838)

And so we took all of those different stratifications and we did a pilot study with a clinic here in New York and we said, can we actually get better outcomes by leveraging the microbiome as a starting point, comparison to the standard of care, which is essentially like looking under the microscope and seeing what bacteria could potentially be there. And we were able to see really excitingly, we were able to shift 80 % of people's microbiomes from a state of dysbiosis into a lactobacilli dominant state. And so that was kind of like the foundation of our treatment programs.

And we started off treating very specific people, and then we got more information on what was working for who and how well, and we started expanding our treatments based off of what we were seeing in the data.

And what are some of the treatments that people are doing? it like targeted vaginal probiotics of the lactobacilli or what is part of that treatment program? Obviously it'll be unique for every individual, but what are a few things?

Great question. So we will essentially a typical care program for like someone in dysbiosis with recurrent vaginal symptoms would potentially look like boric acid to address potential biofilm for seven weeks, seven days, which is a very common thing doctors prescribe. And then a targeted antibiotic. So one of two different antibiotics. If the person is prone to yeast infections, we'll do a compounded antifungal with an antibiotic to prevent a yeast infection.

and then there'll be a vaginal probiotic that we offer in order to rebuild the healthy bacteria. So the standard of care is essentially like, you know, throwing a grenade at your vagina and expecting everything to regrow and we're kind of hand holding it and thinking about the entire community in terms of prevention.

KAYLA BARNES-LENTZ (16:11.392)

Yeah. And that's, that's definitely one, one issue is just so broad, right? It's just, here's a broad spectrum antibiotic. Then the other issue is that taking all these antibiotics really also wreck havoc on your gut over time. If you don't, and especially if you're not having a plan to get those beneficial bacteria back. So really excited. feel like this is just incredibly underserved, but it's so sad that women like go to the doctors because of these problems.

that are apparently so prevalent as you've just educated me on today. You said, think 30 % of women have like some sort of BV at any time. That's really a large number. So I'm excited that you guys are doing this and this more targeted care is also so exciting.

One of the other things that we're doing that is just, you know, takes a little bit longer is actually understanding how can we leverage our data set to create better treatments and better therapeutics, you know, really understanding for the non-responders in our data, you know, what are potential targets that we're not thinking about right now. And working with amazing companies, like there's a company called Darya Biosciences and their expertise is in pharma for women's health. And so really establishing partnerships to actually get to a point where we're not treating with something that was, you know, invented in 1980.

Yeah, absolutely. Okay, we know what the good bacteria is in the vagina. So are you starting to like index and profile? Like how many like bad invaders are being found in the vaginal microbiome? And then do we have any idea is like one link to, you know, yeast infections or something of that nature?

Yeah, are several known bacteria that cause specifically bacterial vaginosis versus aerobic versus yeast infections. But what we're actually trying to understand is which ones, like the cause versus correlation, like we see bacteria there, are they actually causing the infection? Are they actually linked to these broader health outcomes? Like what is the activity in the transcriptome of these bacteria that we see rather than just saying, you know,

PITA NAVARRO (18:16.6)

Prevotella is always present in these women or what combination of bacteria is present in women who experience infertility or cervical cancer progression? Like what are much more precise predictors of these broader health outcomes? We have a pretty good idea and we have characterized most microbial signatures of vaginitis, but now we're kind of going a step further and understanding novel microbial signatures of the broader health impacts.

That's so exciting. What do you think the timeline might look like for having just more publicly available data on them?

Yeah, so we're currently running a study with an IVF clinic to understand markers that could be predictive of IVF. And so hopefully we'll have that study wrapped up this year. And then we'll likely also look into, we have a pretty big gynecological cancer cohort within our group. We're really interested in also understanding the link between like the gut vagina access of like, we see a lot of women with chronic vaginitis who have sepo.

or IBS. And so I would say there's a big focus within EVI and the fertility population. We really think that, you know, if we can even help the 30 % of women diagnosed with unexplained infertility to say, actually, 5 % or 10 % is potentially microbial, and that's a very relatively easy fix. And so really understanding for these patients that are struggling to conceive, even through assisted reproductive technology, how can we leverage something that is so accessible and,

we're able to modulate the microbiome. And so it's also something we can try and help with.

KAYLA BARNES-LENTZ (19:55.712)

Yeah, absolutely. When you say IVF, are you referring to like the actual collection of eggs or actually implanting the eggs and then developing into a birth or both?

Great question. So I'm referring to implantation success. Implantation success and then successful pregnancy as well. And so if you think about it, a lot of people are focused on embryo genetics and making sure that the embryo is as perfect as possible. But even in euploid embryos where they have tested for a lot of potential malignancies, the success rate is around 65%. So we have

a lot of reason to believe that you're implanting the embryo into an environment where the microbiome is really playing a role and could potentially aid in the rejection of the embryo or the failure.

Yeah, absolutely, that makes a lot of sense. I wonder if there is any correlation at all in relation to how many eggs you get and the quality of eggs with the vaginal microbiome as well.

Yeah, most of the research has been done on implantation and pregnancy success, but I definitely do think that these bacteria are causing a lot of inflammation and they are very related to the tissue. And so there's definitely potentially something there, but we really haven't studied it.

KAYLA BARNES-LENTZ (21:23.694)

Yeah. Do you see difference with aging and the bacterial makeup in the vaginal microbiome at this point? Like, does the makeup when you're 30 look different from when you were 20 or when you're 50?

Yes, we see a big change when someone starts going through perimenopause and into menopause. And so we really see a decrease in lactobacilli because he starts experiencing the decrease in estrogen. And so we can literally tell, we have a longitudinal cohort of women that are perimenopause, intimenopause and postmenopause. And we can literally see the decline of the lactobacilli. And in some women,

They don't necessarily experience vaginitis, but other women, that's when they start, you know, they've never had a vaginal infection before, and because they don't have that protective barrier, now they start experiencing recurrent UTIs or vaginal symptoms.

Hmm. What had been like some of the most exciting, you know, learnings that you guys have found or made on this whole journey?

Yeah, that's a great question. think honestly, being able to bring sequencing technology to an area that we're not applying it in any form, like we are now predicting everything there is to predict and sequencing everything and other areas of medicine. so bringing in technology into women's health and actually understanding the data and then providing the care programs already for vaginal symptoms makes me really excited that when we start

PITA NAVARRO (22:54.744)

predicting risks of gynecological cancers or fertility outcomes, that we now have the data to understand what is likely to help reverse that risk. And we have the care programs that will be able to do it. So really building a data set that we can mine and then making sure that we can take the insights and give them to patients or license them to a diagnostic company to make them accessible. So building that playbook of making better diagnostics and mining for better markers for women.

I love that and where are you getting all the data from? it just from people that are purchasing Evvy kits or are you partnering with other?

So when someone activates their test kit, you have the opportunity to consent to be part of the research that we're doing, or you can opt out of the research. But we have a 97 % opt-in rate into research. And so honestly, it's been amazing. Women have really approached Evy as like a citizen science. People are always telling us, can I send you all of my other lab tests so you can start correlating with the research that you're doing?

And so we're really excited to potentially expand even the type of testing that we offer so that we can advance the research that we're doing.

Yeah, you know, cause it might be interesting to relate it up not only to the gut microbiome, but also the oral microbiome, because we know that's kind of like the entry point, right? so that could also be really interesting.

PITA NAVARRO (24:21.006)

Definitely. There's a couple companies that we've, we're starting to establish partnerships with. Biome has really interesting, obviously they do, metatranscriptomics on the gut and the oral microbiome. And so there are conditions where we think that the gut might be a better marker. For example, endometriosis, we're taking a look at how can we build a diagnostic using the microbiome? Is it going to be a gut microbiome marker? Is it going to be a vaginal one? Is it going to be a combination?

And so really establishing those partnerships and expanding the depth and the breadth of our data is going to help us get there faster.

That's actually a great topic. and Demetriosis, have you guys seen anything or have any data on that just yet?

Yeah, we have a large cohort that we're currently running a lot of different models on to figure out if we can find signal and predicting endo. think we'll likely, we have found specific markers, but we want to then go out and validate them in a much more precise way because right now we have real world data. And so we can say, you know, of these patients, we know we're diagnosed, but when you start comparing them to people, we don't know if that person, you know, just hasn't been diagnosed or definitely doesn't have the disease.

And so we're doing a lot of validation for the markers that we're finding for endometriosis.

KAYLA BARNES-LENTZ (25:33.87)

Yeah, that's so interesting. What about the link to ovarian longevity potentially? So this is something I'm very interested in. I'm sure you know this, but it seems as if we know very little about why the ovaries age at double the speed of all other organs. It's 2025 and we're like at ground zero. As you mentioned, know, women weren't required to be included in research until the early 1990s, which is wild. But

What do you think, I mean, and even if you don't have the data, just maybe like hypothesizing here, how might being able to maintain like a more optimal vaginal microbiome potentially impact like ovarian longevity? Do you think there's anything there?

I think, you know, the links haven't been established. So I don't want to say like this is for sure, but from we've seen an early data and I do find that there could be some women that experience premature ovarian aging due to chronic inflammation and metabolic dysfunction linked to the vaginal microbiome. We do know for sure that

dysbiosis is linked to higher levels of inflammation. And so I think those levels of inflammation can then impact and accelerate ovarian aging in a way. It just hasn't really been quantified. But having ongoing chronic low grade inflammation from dysbiosis, I think is definitely potentially linked to poor quality or reduced ovarian function. We haven't studied that. This is my hunch from a scientific perspective.

But I do think obviously you know inflammation is the biggest driver of cellular aging. So if you experience the chronic inflammation, there must be a link.

KAYLA BARNES-LENTZ (27:17.302)

Yeah, absolutely. It's on the roadmap at all to look at like potentially like ovarian insufficiency or premature ovarian failure and be vaginal microbiome.

Yeah, there's exciting partnerships that were hopefully at Cantis-Wales right now, but definitely will allow us to not just leverage the vaginal microbiome, but also potentially look at ovarian imaging, longitudinal reports of ovarian imaging, and how can we link that into what we're seeing in the vaginal microbiome.

Nice, that is so exciting. Hi guys, I'm going to interrupt this episode for a brief announcement. As you may or may not know, I started a community for females, by females, and it's a female longevity optimization community. This is a place that you can connect with like-minded women. We are all here to support each other, and there's a variety of different benefits to being a member. You get a monthly Ask Me Anything, so submit your questions and I'll answer them directly.

We also have an entire library of courses on all of the important components of longevity such as labs, nutrition, exercise, sleep optimization, longevity optimization protocols that I'm doing along with real time updates to my personal protocols. There are so many benefits of being a member of the community. We'll also be doing in-person live events here in California and virtual events for anyone that can't attend.

But if you're interested in joining the community, I would absolutely love to see you there. And I will include a link in the show notes. So I want to talk a little bit about, guess, would typically happen when women are going to the doctors for some sort of, we know what the treatment is, but what about the difference in the testing that you're doing and what you're looking at versus what would you normally receive at your standard doctor visit? Let's say you go in with, you know, a yeast infection, what would they be looking for versus like what you guys are looking for?

PITA NAVARRO (29:06.476)

Yeah, most doctors, they'll do a culture or the standard guideline for diagnosing BV is essentially the AMSOIL criteria, which is one, checking for what type of discharge someone has, looking under the microscope and examining the discharge and smelling. So it is almost offensive, honestly, how doctors, even the tools that we have, and they'll sometimes culture. Based off of that, then they are also very limited when they diagnose, but

The doctors are more likely to misdiagnose someone than correctly diagnose them. And even when they're correctly diagnosed, they're more likely to recur than not. And so clearly, the limited way of diagnosing is not serving women. And so the difference, there are some doctors that are now leveraging PCR tests. So they'll do a swab and they'll run a PCR test. they'll check, is the DNA of this one or four bacteria there?

The limitation with that is that we now know that there are hundreds of bacteria that could potentially cause this. And so when a swab comes back that checks for four bacteria that's negative, the doctor's gonna say, you don't have an infection, I'm not gonna treat you. Or you have symptoms, even though this came back negative, I'm still gonna give you this antibiotic. And so the difference is what we're doing is we're doing whole genome sequencing. So you can think about it as PCR, you check for one or two bacteria, maybe three.

there's another level of sequencing called 16S, which you essentially take one variable region and you amplify that, assuming that the rest of the sample looks like that, which is a lot more accessible than metagenomics, what we're doing, but you're still missing key species in the vaginal microbiome that could be playing a role. And so we're looking at all of the bacteria and fungi present and then letting you know the relative abundance. So what percent of your microbiome is each bacteria?

Yeah, that's super helpful. And about how much does the test cost?

PITA NAVARRO (31:05.39)

Yeah, so the test, there's two different tests. We got a lot of feedback that patients also wanted to test for STIs, while, because we can't test for STIs with metagenomics. So if you want the STI, it's going to be 218. And if you don't want the STI, it's 159.

Nice and yeah, that's pretty reasonable, think. Which is great for really advanced tasks. Question for you, have you seen this floating around the internet lately? That BV is now classified as an S-

Yes, huge debate going on in our fields right now. I think for years and years, were telling women, women were going to the doctor and saying, every time I have sex, I get BB. And we hadn't established the link between it can be sexually transmitted. And so finally, this study has said, we actually did find a reduction in recurrence by also treating the male partner.

So I think there's going to be a lot of debate around what makes something an STI. I think it definitely helps doctors treat it and screen for it differently. But there are other things that can cause BV. I would say it can be sexually transmitted. But there are also things like fluctuations in your hormonal cycle or your period that can potentially cause it. So I think it'll be interesting to see what it comes out of. I hope that now.

you know, women who do experience it through sex will have better treatment options though.

KAYLA BARNES-LENTZ (32:38.936)

Hmm. Yeah, that's so interesting. So is there anything like a signature in the vaginal microbiome that you're familiar with as of now that is linked to something like a STI?

Yeah, so we, we have now done like a lot of studies on our patients who are positive for STIs and understanding what does the microbiome look like when this patient has an STI? I would say by declaring BV as an STI, there's a lot of nuances that come with it in terms of prevention and recurrence. I do think though now we'll have to

leverage a test like EVI in order to understand how to treat it if it is considered an STI rather than, you know, having a simple PCR test because BV molecularly hasn't really been defined. And I, and I'm very excited because I think that's where EVI is going to be able to play a big role.

Absolutely. And part of your guys's mission is really just contributing to women's research,

Yes, exactly.

KAYLA BARNES-LENTZ (33:46.006)

And where do you think, how did we get in this position, first of all, to be so deficient in female health medical research? And do you feel good about the future outside of even what you guys are doing is amazing, but how do you feel like the entire field is going as a whole?

Yeah, so before 1993, most pharma companies didn't include women in clinical research because they viewed hormones as a variable they couldn't control for. So they were scared that hormones were going to ruin their efficacy or change something. And it was something they couldn't necessarily control for in their analysis. And so they instead say, let's assume women are small men and let's decrease our doses. Or when we build screenings, they never really

understood if the screening procedure would prevent heart disease in women or or just in men. And so I think there is even though there's a lot of awareness around it, we are still decades behind, honestly. And it is very discouraging to see everything happening with the funding around biomedical research. I do think that we are taking a step back, honestly, I would say I felt slightly encouraged.

until all the freeze happened because our universities, so much of the research being done is in universities, right, through NIH grants. And so I do fear that that is definitely going to, it's gonna slow down the catching up that we had to do. Because if you think about it, it's not just female specific conditions, but it's accelerating the research in conditions that affect women disproportionately, autoimmune conditions, or differently, like diabetes or other metabolic conditions.

And so we were kind of advancing and establishing better research around female specific conditions, but sex as a biological variable, I don't think is going to be encouraged. What's studying other conditions like Alzheimer's or autoimmune conditions for now?

KAYLA BARNES-LENTZ (35:51.306)

Interesting. Yeah, I'm not like super up to speed on what's going on with the funding. Can you give us like just a really

Yeah, so there's a lot of freezes on NIH grants that have, they came out with a list of like forbidden words, and female and women are in the list of forbidden words and men and male aren't. And so it's going to be interesting to understand, you know, when you're applying for grants to get funding for female specific conditions or to understand

the differences and implications of the disease in females, then I do think we're going to see a lack of funding. And even though, even before this lack of funding, it was only 2 % of research funding going into women's health.

Yeah, it's really a problem Wow, well does not good and yeah I need to be a little bit more educated on that whole topic because I is obviously very important, you know

Now there's things changing every day. I'm hoping that it gets reversed, but there is things changing every day. I think at the same time that, that opens up a massive opportunity for companies like Evy, because we're so close to the patient. We can now, we have an amazing research platform and we have amazing investors who believe in our mission. And so I now just feel a tremendous, you know, responsibility to, to expand our offerings and expand the type of research we're doing from a private perspective. Yeah.

KAYLA BARNES-LENTZ (37:20.12)

It would be so interesting to know too, like how the bacteria change based on where on your cycle.

Yes, yes, yes, yes. There's definitely a lot of research that has tracked women throughout their cycle. And we do see, we see a variance that is very predictive. Like if you test at the same time in your cycle, it's going to be similar to that time previously, but there is a fluctuation because we do see the vaginal microbiome is highly estrogen responsive. And so as levels fluctuate, we do see the bacteria change.

Interesting. And what about pregnancy? Have you guys kind of like parsed out that cohort?

Yes, we have actually, we have 157 women who have tested before getting pregnant and then during pregnancy. And so that's a really interesting study that we're running. But there are studies that link to the microbiome being predictive of microbially driven preterm birth. And so if you test in the first trimester, it's a lot more predictive than later on. But there are amazing academic researchers looking into.

pregnancy and preterm birth and the vaginal microbiome's role.

KAYLA BARNES-LENTZ (38:31.736)

That's so exciting. Based on everything that you've learned, what would you say are like your top three to five recommendations for women if they can't get the test? Obviously we'll include links and all of that to the test. And I can't wait to get mine and I'll share my data as to what's going on. And then I'll do some end of one stuff to optimize it. If it's not doing well, hopefully it is. But what would be like top three to five recommendations for women?

in terms of maybe lifestyle potentially that you would make.

Yeah, I think most of the things that are helpful for gut and systemic immunity will be helpful for vaginal health, right? Like we know nicotine reduces lactobacilli levels, increasing the risk for BV. We know that alcohol has an effect and can alter the gut microbiome, which is linked to vaginal microbiome shifts. So overall, relative lifestyle factors, definitely decrease smoking, decrease alcohol intake.

Any cycle irregularities are definitely linked to chronic vaginitis. And so I would say if you can't get the test, at least try and work with a provider who will help you understand how to regulate your cycle better. And definitely when it comes to fertility, I would say advocate for yourself and try and seek better answers. We have a lot of education on our website linking, making the research more accessible and

making it helpful in terms of like what can I actually do.

KAYLA BARNES-LENTZ (40:05.492)

Interesting. When you say that irregular cycles are linked with more dysbiosis essentially, so you want to try to get your cycle a little bit more regular, why do we think that is? Is it because again the fluctuations in estrogen?

Yeah, all of the hormonal fluctuations or like prolonged periods lead to an increased pH, which also leads to an increased likelihood that the bacteria are likely to thrive. And so I think really understanding like from a hormonal perspective, even for example, if you are, if you have low estrogen levels that could potentially be linked to, know, that could contribute to recurrent vaginal symptoms because the healthy bacteria need.

like a glycogen produced by estrogen to survive. And so I would just be very mindful and listen to your body in terms of what you're feeling that could be linked hormonally. And yeah, and I would say just advocate for yourself when you're experienced vaginal symptoms at the doctor's office and find providers that are willing to listen to you.

Yeah, I mean, I absolutely agree. And it's just so great that we have access now to something a lot more in depth than it sounds like we have had really access to in the past. So is there anything else that you want people to know about Evy?

I mean, we are here, any questions that people have, our team, even though you don't purchase a test, we are happy to answer any questions you have about your vaginal health. And we are trying to add as much information as possible from a scientific perspective, but also from a consumer perspective. So yeah, we're very excited to hear from people and what they're interested in or what problems they've been having.

KAYLA BARNES-LENTZ (41:48.546)

Yeah, absolutely. Well, I'll drop, you know, I have a longevity community that is members only. people are a little bit more comfortable to share in there. So I'll also ask for some feedback in that community podcast episode. So

Yes, any feedback. are a female, you know, started female led company, always wanting feedback and, and really all we wanted to do is make science more accessible and, you know, improve outcomes. And I'm happy to share a code with you for your points.

would love that. Can we make it, can we decide right now? Can it be Kayla?

You want me now? Of course.

Okay, great. So perfect. Well, we're going to do a code for everybody listening. It's going to be code Kayla. What will the discount be?

PITA NAVARRO (42:28.782)

I will have to double check that I'm sure we can at least do 15%. Okay.

I'll include in the show notes what the final discount is, but that was so generous of you. Thank you.

Of course, it was amazing to talk to you and I'm such a big fan of what you're doing. So I'm looking forward to potentially collaborating more in the future.

Absolutely. mean, right back at you, I think we have a very similar mission. We just want to make women thrive and have more access to, you know, science-based and backed protocols to feel better. And I think that's really the same goal here. Well, thank you so much for being on.

Yes, exactly. Thank you, Kayla.

KAYLA BARNES-LENTZ (43:10.882)

This podcast, including Kayla Barnes, does not accept responsibility for any possible adverse effects from the use of the information contained herein. Opinions of their guests are their own, and this podcast does not endorse or accept responsibility for statements made by guests. This podcast does not make any representations or warranties about guest qualifications or credibility. Individuals on this podcast may have a direct or indirect financial interest in products or services referred to herein.

If you think you have a medical issue, consult a licensed physician.

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