Another US femtech startup has joined the race to construct up data-sets to support research into and understanding of a vary of health points that may have an effect on ladies.
Evvy has at the moment launched an at-home test equipment for the vaginal microbiome. The consumer returns their swab to the startup for evaluation — and will get detailed information and evaluation of the microbes (fungi and micro organism) which might be current of their vagina and could also be related to a number of health issues.
Users of the test additionally get personalised options for issues they might strive (corresponding to food regimen and way of life adjustments) to enhance the stability of microbes — doubtlessly serving to with associated heath points they might be affected by, like yeast infections or BV.
Variances within the microbes current in a person’s vaginal microbiome are thought to have broad implications for women’s health — taking part in a position in comparatively minor infections (like thrush) however Evvy additionally flags research linking imbalances within the vaginal microbiome to extra critical points like infertility or pre-term beginning, and even linkages to the development of cervical most cancers.
Decoding the vaginal microbiome is thus seen as a chance to support a broad vary of women’s health objectives.
“We give users back a full understanding of everything that’s present. So here are all of the bacteria and fungi and importantly what is the relative amount of each of those bacteria,” explains CEO and co-founder Priyanka Jain, noting that customers additionally get their test information in a downloadable format to allow them to take the information to their healthcare supplier if they want.
“There are certain bacteria that play really important roles in the vagina, either positive or negative, and understanding if that’s 90% of your vagina vs 5% makes a big difference… For every single microbe that we show to a woman we also fully explain what that microbe is, what the scientific understanding of it is today, how it might contribute to symptoms, how it might be behaving with other microbes that exist in your vagina — as well as if research has shown that it’s related to any health outcomes that you might care about.”
“We also give every woman a full personalized plan — that includes ways to help reduce any type of disruptive bacteria, ways to promote their protective bacteria and ways to overall maintain their vaginal health based on their personal life experiences,” she provides.
As with many such femtech startups, Evvy is focusing on the women’s health information hole. This refers to how ladies can have a comparatively poor expertise of conventional healthcare, maybe particularly when looking for assist or support with situations associated to feminine biology, due to historic under-representation of ladies in medical research — which implies feminine health situations have a tendency to be much less nicely researched and understood vs situations affecting organic males.
Even comparatively widespread situations which might have an effect on the vagina — corresponding to a easy yeast an infection — may be frustratingly troublesome to join to particular person triggers. And whereas over-the-counter remedies do work, some ladies report recurrent infections — and will profit from a higher understanding of why the infections could also be occurring within the first place.
The drawback of much less research into women’s health points does additionally imply that femtech startups can have a lot of floor to cowl to reside up to engaging pitches of ‘demystifying’ the feminine physique, as Evvy couches it. In its case, a key problem is clearly analyzing the vaginal microbiome information it will get from customers and turning it into helpful suggestions for every individual — with out overpromising, given there could also be comparatively little research to again up doable hyperlinks to wider health situations.
Evvy says it tackles this problem by signposting the extent of research related to every of the personalised options it provides.
“I always say treat women like they’re smart,” says Jain. “What we really do on every of our suggestions is we fee them. So they’re both rated as ‘novel’, ’rising’ or ‘established’. And we present the ladies that is the research that exists on the sort of remedy [and how relevant it might be to them personally — based on] if it was performed on those who resemble you sufficient that you’re really involved in what the outcomes are.
“Our goal is to highlight everything that’s out there. Because women are… looking for answers everywhere — and you see this kind of amazing crowdsourcing of knowledge, of people trying to figure out what might work for them — and our goal is to say, from a scientific perspective, this is everything that has been studied and we are actually just transparent about how well researched each of those things are.”
Jain says wider research-related objectives embrace attempting to establish biomarkers with suspected hyperlinks to a swathe of significant feminine health points — corresponding to infertility, preterm beginning, STI acquisition and cervical most cancers development.
Although it’s essential to notice that Evvy’s industrial providing comes with a disclaimer that it’s not offering medical recommendation — and is simply promoting a “wellness” test for now. This is as a result of the service shouldn’t be a regulated medical system. Hence Evvy specifies it’s solely offering clients with “information” about their vaginal microbiome (though the co-founders informed us they might think about making use of for FDA clearance sooner or later).
The hole in data round feminine health points has led to a proliferation of ‘wellness’ claims and merchandise focused at ladies — a few of that are, sadly, peddling what quantities to ‘snake oil’; i.e. promoting merchandise that lack rigorous scientific research to underpin a fuzzy vary of ‘holistic benefits’ steered by the related advertising and marketing (crystal-healing yoni eggs, anybody?).
Being within the unregulated ‘wellness’ class subsequently has dangers for any femtech startup. But Evvy additionally sees a chance to reduce by means of a few of the noise and doubtful claims by arming ladies with strong information on what’s occurring of their our bodies and connecting them with real scientific experience that may assist them interpret it.
Education is a key aim for the startup, per CMO Laine Bruzek.
“How can we bring the scientific community, care providers and women together in the same place to get their questions answered quickly and with the best scientific information… Education is just such an important goal for us because there’s not a lot of great information that exists on the Internet,” she says.
“Not just about your vaginal microbiome — which is sort of a new and emerging space — but just vaginal health in general. There’s so much misinformation, there’s so much snake oil that people are selling. So we want to make sure that we have, not just a chance to bring the women together, but that we give them access to people who are pushing the bounds of vaginal health research so that they can get the best information when they need it.”
Evvy’s strategy — which incorporates bringing in OBGYNs and specialists in gynecology & reproductive health as advisors (though the founders themselves have information science and product design backgrounds) — has attracted some top-tier buyers: Today it’s saying a $5 million seed spherical led by General Catalyst which is able to see the fund’s Margo Georgiadis (previously the CEO of Ancestry.com) be part of the board.
Commenting in a assertion, Georgiadis mentioned: “Evvy is breaking boundaries to advance women’s health with more affordable and comprehensive testing starting with its vaginal microbiome metagenomics test. The team has bold plans to enable greater early detection, improved treatment, and enhanced therapeutics using new female-specific biomarkers.”
“There is a huge opportunity to build new datasets that will transform our understanding of these conditions in the female body, and I truly believe that Evvy’s unique platform combined with the development of new therapeutics will catalyze a new era in women’s health,” added Dr. Craig Cohen, professor of obstetrics, gynecology & reproductive sciences at UCSF and advisor to Evvy in one other supporting assertion.
Evvy shouldn’t be the primary startup to promote a residence testing equipment for the vaginal microbiome, focusing on ladies who could also be affected by situations associated to microbial imbalances, or — nicely — simply ladies who need to be taught extra about their very own our bodies.
Juno Bio, for instance, launched an at-home test equipment final 12 months.
But Evvy is utilizing a method — referred to as metagenomic sequencing — which the founders say is ready to seize extra information than different industrial exams, or the everyday exams a girl is ready to acquire through a physician’s workplace (the place scans might solely search for a few particular pathogens). So the pitch is the strategy supplies a increased constancy view of what’s occurring inside a girl’s vagina.
“A lot of the work that we’ve done is specifically incorporating what’s called metagenomic sequencing into the analysis of the vaginal microbiome,” explains Jain. “When you go to the physician’s workplace the kind of test that they will run is what’s referred to as a PCR test — basically they take a pattern they usually search for a particular pathogen inside that pattern. So oftentimes whenever you go to the physician you’ll get a PCR test that appears for one to three completely different people pathogens.
“Since then there have been a few iterations of enhancements on that performed by different corporations. Some aren’t utilizing what’s referred to as 16-S sequencing — which is a type of amplicon sequencing — which is unquestionably a massive step up from PCR however the draw back is it’s solely ready to take a look at sure variable areas of the genome. And you even have to pre-define what you’re on the lookout for. So it’s a lot more durable to do discovery and also you’re not ready to discover all micro organism and fungi which might be current. Because 16-S really can’t detect fungi in any respect so you might have to individually test for it — which implies you’ll be able to’t perceive their relative relationships.
“So our test is really the first time anyone is using metagenomics at scale to better understand the vaginal microbiome; both for individual woman and the healthcare system as a whole… In the same way that 16-S was an improvement on PCR, metagenomics is just an improvement on 16-S; it allows us to understand everything that’s possibly present across all bacteria and fungi.”
Per Jain, the service is the one commercially accessible vaginal microbiome test that’s ready to use metagenomics.
A key a part of Evvy’s work as a startup is then the evaluation of this increased dimension information it’s capturing — to map completely different microbes to potential health outcomes (primarily based on its evaluation of present research) — and perceive how to interpret particular person findings and supply related and actionable information to every consumer.
“A lot of our work has been on the data analysis part,” confirms Jain. “So whenever you do metagenomics sequencing you get a lot, a lot increased constancy information again — and we had to construct out every thing from, we co-developed a tremendous bioinformatics pipeline that’s ready to analyze that sort of information and perceive which micro organism and fungi they’re. And then really mapped out for every of these micro organism and fungi how are they associated to the vaginal microbiome? What sort of signs would possibly they trigger, and in addition what sort of health implications would possibly they be associated to.
“Lastly we’ve done a tonne of work with our science advisory board around putting together personalized recommendations that take into account — not only the microbial data that we get from the test — but also someone’s health history and their symptoms, and if what stage of menopause they’re in, or all of this other information so that we can actually make this information actionable for the women.”
Once information from paying customers begins to stream the concept can also be to support a vary of Evvy’s personal research initiatives and partnerships (on the latter, particular particulars are being stored underneath wraps for now) — all geared toward furthering data of women’s health and supporting what they hope will likely be extra merchandise in future.
“There’s been so much research done showing that the vaginal microbiome is for example related to pre-term birth,” says Jain. “When you look at women who deliver early or pre-term, they tend to have very different vaginal microbiomes than women who don’t. But a lot of the sequencing that’s been done in that space has been using things like 16-S — and our goal is to bring a much higher level of fidelity. And so, more specifically, we can look at the strain level of bacteria — whereas 16-S and other forms of sequencing can only get you to the species level. And when we’re looking at something as complex as pre-term birth, cervical cancer progression and STI acquisition it’s not just what’s there — but it’s getting to the very, very high fidelity information of specifically what strains are there. So that we can actually start to discover what are the biomarkers that might be leading to differences between people who deliver pre-term and people who don’t.”
“The other value of metagenomic sequencing is it gives us functional profiling,” she provides. “Which helps us not only understand who’s there but also what they might be doing — and all of that information together is more likely able to help us better understand these complex conditions that research has shown is related but no-one’s been able to figure out exactly how.”
While the overarching aim is that information from customers’ vaginal swab samples will support research into a vary of women’s health points, Evvy’s customers are additionally paying for a industrial service to get their particular person evaluation — so what can they anticipate?
The at-home swab test equipment is being priced at $129 for one test equipment — which delivers them with a personalised evaluation after two weeks.
Evvy can also be providing a membership fee for customers who need to give you the chance to perform a number of exams — to give you the chance to monitor adjustments to their vaginal microbiome — and for these customers exams will price $99 every (with the consumer ready to take a test each three months).
As they launch the service throughout the US’ 20 states, Evvy’s co-founders say they’re hoping “thousands” of ladies will enroll to quantify their vaginal microbiome and support the broader aim of backing research into feminine health.
“Why is it that looking at the bacteria in the vaginal microbiome is 94% accurate in predicting whether or not a cycle of IVF works?” asks Jain. “Why is it that girls who give beginning pre-term have a differing vaginal microbiome than individuals who don’t? Or the entire cervical most cancers development, STI acquisition, pelvic inflammatory illness.
“There’s so many situations that appear to be — both the vaginal microbiome is an attention-grabbing diagnostic alternative [or] there’s even some very early research displaying that girls who’ve PCOS [polycystic ovary syndrome] or endometriosis have various markers of their vaginal microbiome from ladies who don’t have these situations — so every thing from serving to to detect illness to serving to diagnose issues, to serving to predict danger for thus many of those situations that always we don’t catch for too lengthy.
“Also thinking about treatment as well — something like IVF success or pre-term birth — if we’re able to identify risk earlier can we actually come up with interventions that are personalized to that individual person so that we’re able to avoid that negative outcome in the long term?”