The other day I was flagged by multiple people regarding an article about Evvy, an at-home vaginal microbiome test. This new startup wants to harness the power of the vaginal microbiome to help people understand their vaginal health while making the world a better place.
(Ok, that last part is a nod to the show Silicon Valley).
The founders of Evvy want people to test their vaginal microbiome at home because there are many medical conditions related to disturbances in the vaginal microbiome.
Yes, there are many conditions related to disturbances in the vaginal microbiome, but where the company goes astray is the claim that testing your microbiome with Evvy can help you understand those issues and personalize your medical care. One of the founders even claims it may help some people “actually get pregnant." There is no basis to this claim.
I am an expert in vaginal health and yes I do wish we had better testing to help us understand the vaginal microbiome. There is so much about that we have yet to learn… and we will certainly not get that data from Evvy.
First of all, the vaginal microbiome is constantly in flux. It can even change from morning to evening. We also don’t understand many of the reasons why some people develop recurrent vaginal infections and others don’t. There are some findings definitely associated with problems with the vaginal ecosystem, such as sex with a penis and douching, but beyond those broad strokes we have very little insight. This isn’t, as Evvy suggests, for want of trying. There has actually been a fair bit of research into the vaginal microbiome ever since disturbances in the vaginal ecosystem were found to increase the risk of acquisition of HIV and gonorrhea if exposed.
I started my fellowship in infectious diseases in 1995 and we had plenty of discussions about the vaginal microbiome back then, although admittedly much of what we knew then has changed given the technological advances that have allowed us to have a much greater understanding. Anyone wanting to learn more about what we do know could read this review article or this one. While it is true there could be more research in the area of vaginitis, what we need are more studies, like this one from 2015 that enrolled almost 400 women with no symptoms and evaluated their microbiome. We also need more clinical studies, meaning not just what the microbiome looks like for otherwise healthy people, but what changes after taking yeast medication, or what the microbiome looks like for complex vaginitis and how it changes after therapy.
Here are some examples of the complexity of the vaginal microbiome. About 20% of women on any given day have yeast in their vagina by culture (I use the term women here as in this data set the people enrolled in these studies were identified as women), but most do not have symptoms. It’s not whether someone has yeast, it’s whether that yeast is causing symptoms and we don’t yet understand the reasons why some have yeast that can happily be part of their vaginal ecosystem and not cause any issues and for others this yeast can overgrow and wreak havoc. There are many hypotheses. For example, it may be the specific yeast, either being more virulent (able to cause disease) or forming biofilms (basically protective coating that helps it avoid capture by the immune system or be killed by medication). It’s also possible some people are more sensitive to yeast, in the same way some people have allergies to pollen and others don’t, so they could be having an abnormal reaction to a typical amount of yeast.
I could go on and on about all the variables and unknowns for yeast alone.
So let’s take a look at Evvy.
For starters, what are they testing for?
Apparently, everything that can be found in the vagina. This is not a “traditional health test,” but rather an “exploratory analysis,” which sounds like a euphemism for throwing darts at a wall. I’m trying to think how my patients would react if I said I was ordering an “exploratory analysis?”
This is what Evvy has to say:
We don’t recommend any of this testing for someone with no symptoms, so there’s that.
We don’t recommend testing group B step outside of pregnancy. During pregnancy about 25% of people have this bacteria in their vagina (and/or rectum), and we believe it only becomes problematic if a fetus is exposed during delivery. So what happens when people find out they have group B strep in their vagina from Evvy and didn’t need the testing, meaning they weren’t pregnant? Well, I can tell you because unfortunately sometimes a provider orders a group B strep culture when they shouldn’t and the person almost always receives antibiotics that they don’t need. You know what isn’t good for the vaginal ecosystem? Unnecessary antibiotics.
Many of the Evvy test results that are normal could be alarming to people without symptoms. If you have yeast, group B strep, or ureaplasma in your vagina and have no symptoms that is totally fine. And there are no guidelines that recommend any decision making based on having Garnerella in the vagina or on the types of lactobacilli (good bacteria) that may be found.
In medicine we don’t recommend testing for “everything.” which seems to be the translation of “exploratory analysis.” We recommend testing that will help us answer questions. If you have no symptoms, that means no testing. If you have symptoms, that means an exam and then appropriate testing. While some of the tests included in Evvy may be part of a work up of symptoms, most of them are not. What I worry most about with Evvy are a lot of people ending up with additional therapies to treat microorganisms identified on Evvy that likely have nothing to do with symptoms. And of course reams of likely useless probiotics.
Let’s review the Evvy website, shall we?
Why test your vaginal microbiome, according to Evvy.
To “understand your symptoms and risks for critical health challenges.” As I have just explained there is literally no data to tell you what to do with most of the results with Evvy’s microbiome test. So if you bring your test results to your OB/GYN, they won’t know what to do with most of it either. If you have low levels of lactobacillus crispatus (one of the “good” vaginal bacteria) is that important for you? Evvy can’t tell you that. And even if it is, we don’t have effective ways to replace it. Also, the microbiome is dynamic and may even change throughout the day. How can Evvy account for that? So many questions... so few answers.
The second reason is to get a personalized wellness plan.
What is that? I have no idea. Apparently something “actionable” and “holistic” and of course probiotics, except no quality study tells us how to recommend probiotics for vaginal health or even if they work. Diet doesn’t affect vaginal health and there are no supplements for vaginal health. So beyond covering every penis with a condom and quitting smoking there are really no “lifestyle changes” or “holistic” therapies for vaginal health. Vaginal estrogen will certainly help those who are menopausal.
Also, this personalized wellness plan sounds a lot like practicing medicine, so it will be interesting to see how Evvy navigates that space.
One more thought on the “personalized wellness plan.” I do hope it doesn’t involve recommendations from Laine Bruzek, one of the founders of Evvy. She told Insider, "I always say the best things in life cause vaginal infections," and goes on to name a few, "Sugar, bubble baths, sex, wearing tight clothing.” She got 3 out of 4 wrong. Sex with a penis is definitely associated with disturbances in the vaginal ecosystem, but the other three are not. Maybe the founder of a company that claims to offer expertise in vaginal health should actually know a little about vaginal health?
The third reason is to stop spending money on treatments that don’t work.
The irony is that this statement comes immediately after the claim that Evvy will make personalized recommendations based on who knows what data?
Since you will no longer be spending money on treatments that don’t work, instead, I guess you will be spending your money on Evvy. No really. They want you to test your microbiome over and over again. You can even get a deal if you subscribe to get 4 tests a year, $99 per test versus $129. So I guess the more you spend on Evvy, the more you save? Isn’t that the advertising slogans for stores in retail outlet malls? And then add that cost to their personalized health recommendations? Sounds very pricey.
This is a biggie. CLOSE THE GENDER HEALTH GAP.
This is where they admit they are building a data set. Make that push to subscribe more understandable, because that will help Evvy build a better data set to sell.
Many people with vaginal health concerns go undiagnosed and get inappropriate therapy, but for most of these people that isn’t the result of inadequate research, it’s the result of bad medical care or the lack of pharmaceuticals to treat resistant yeast. This is the gender health gap. Evvy is just gonna slide right into that gap and double dip as not only are they charging the consumer, but Evvy can literally make money collecting your data and selling it. It’s a great business model, but scientifically questionable for many reasons. For example, people who buy Evvy are more likely to have problems and use therapies. So if they do have a disturbance in the vaginal ecosystem, is that the original issue, or the result of the inappropriate therapies? Even if the data were clean, the idea that researchers looking to understand the microbiome will turn to Evvy seems doubtful as the way Evvy is collecting data is unlikely to get past an Institutional Review Board (IRB). Research studies are typically free for the participant and involve detailed informed consent, neither of which is happening here.
What makes this even more frustrating is we have been here before. In 2017, to be exact, with a company called uBiome that had a test called SmartJane. One of the cofounders told Forbes, “We’re trying to work with the establishment to help women’s health care be better and more convenient and more inclusive.” Sounds familiar. Like Evvy, there was also a hefty price with SmartJane and at the time when actual experts (including me) were interviewed the consensus was that we had no idea what to do with these results and there have been no studies to say otherwise in the intervening years. I had several patients do the SmartJane test and they were upset when I couldn’t use the results, so I know exactly what to expect with Evvy. It is always hard to tell people that they were led astray by a company.
So what happened to uBiome and Smart Jane? The co-founders were charged with defrauding health insurers and investors. No really. You can read what the Feds have to say about uBiome here.
Now obviously uBiome being charged with Federal Securities fraud has nothing to do with Evvy, but it does show there is a lot of potential in the direct-to-consumer testing space for abuse. However, as selling data that you the consumer paid to obtain to Pharma has already been road tested by 23andMe, I assume if Evvy follows that model they will be in the clear.
So here’s the deal. Every test needs an indication. This might be a research question or it might be a medical question for an individual. For example, testing for human papilloma virus tells us if we need to be concerned about cervical cancer and if we need to do more testing or not. A test for chlamydia tells us if you need antibiotics to prevent pelvic inflammatory disease. A yeast culture helps us diagnose vaginitis for someone with symptoms and a vaginal culture for group B strep helps us manage delivery for those people who test positive, but these tests are meaningless in the wrong scenarios. And some of the tests in Evvy have no indication at all.
Building a data set is a worthwhile goal, but that doesn’t start with random people paying to build it under the guise of improving their health. To build a useful data set researchers have to decide who they want to include (those with or without symptoms). If they want a snapshot (single point in time) or do they want to invest in a long-term study that follows people over months or years. Researchers also have to decide what variables to measure and why. They need to make sure the data is uniform, for example, collected on the same day of the menstrual cycle. And of course they need informed consent from participants.
There are a few situations where Evvy could be helpful, but I want to be clear these are situations that could also be handled by a competent medical provider with testing already available. For example, someone who has been told over and over again that they have a yeast infection, but their practitioner has only ever looked under the microscope for yeast or diagnosed the person over the phone and there has never been a yeast culture proving the existence of yeast when there were symptoms. If someone in this situation tested negative for yeast with Evvy when they had symptoms they would know their symptoms are not due to yeast and perhaps they could advocate for better care.
Many people struggle with vaginal infections. Misdiagnosis is common and in fact many people who think they have had yeast infections for years actually have vulvar conditions (such as atopic dermatitis or lichen simplex chronicus). Recurrent bacterial vaginosis can be challenging to treat. And recurrent yeast infections and resistant yeast often require care from an expert like me. In addition to doctors and nurse practitioners who may be undertrained or uncaring, there are predators selling useless vaginal products and even harmful ones. The answer to all of this does include more quality research (not Evvy-style), but so many issues could be solved right now with better medical training, access to health care, and fewer predators recommending vaginal garlic, yogurt, jade eggs, or Yoni detox pearls. I guess I’ll have to add subscription vaginal microbiome testing to the predator list.
If Evvy wants to help people, they should be funding studies where data is collected in an ethical way (meaning informed consent and participants aren’t charged) and there is a thought to study design and then publish these results. I can think of several studies they could do off the top of my head, however, none of them would turn into money makers, although they would help advance the care of those with vaginal infections. Also, Evvy should not be advertising that they can recommend a personal vaginal wellness plan based on their results. There is no data here, so that is a predatory claim. If there were “holistic” vaginal wellness plans that worked then they would be known to experts like me. Then again, Evvy is free to prove me wrong with published peer-reviewed data. I am always up for learning new things and I look forward to reading their papers.
As currently advertised, Evvy isn’t closing the gender gap, the company is simply exploiting it.