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Entrepreneur First -backed Juno Bio has launched a home test kit for women wanting to get a better understanding of their vaginal microbiome while also contributing data to further research into women’s health.

The vaginal microbiome refers to the community of microbes and bacteria that naturally live in the vagina. Variances in the vaginal microbiome are thought to have implications for women’s health conditions — such as recurrent bacterial-vaginosis or a higher risk of contracting an STI, and even preterm birth and infertility. But a historical lack of research into women’s health issues means there’s still a long way to go to fully understand what’s going on. (Or indeed how to intervene to correct an unhealthy imbalance.)

That’s where Juno Bio wants to come in.

Last year the 2018-founded U.K. startup ran a study in the U.S. that gathered samples from more than 1,000 women to build up a repository of data on the vaginal microbiome. That initial data set underpins the commercial Vaginal Microbiome Test kit it’s launching today — at a cost of $149 (which includes free shipping).

Women who pay to be screened will receive a test kit in the post. They then carry out a sample gathering procedure at home, passing a Q-tip-like swab across the walls of their vagina for around 20 seconds and sealing the sample in the tube provided (with stabilizing agents) to return it by post to Juno Bio for analysis.

Once the sample has been processed the user will be invited to log in online and view her results, with the option to book a one-on-one call with a Juno Bio “vaginal coach” to discuss the data.

It’s worth emphasizing that the startup is being careful to caveat what kind of service it’s offering.

A disclaimer on its website states the tests are “currently exclusively intended to be used for wellness purposes” — and it further adds: “The tests we offer are not intended to diagnose or treat disease, or to substitute for a physician’s consultation.”

Juno Bio confirms the test is purely a commercial offer for now — although it says it’s working on “a regulated version” so it will be able to inform clinical decision making in this area in the future, starting with the U.S., which is its initial market focus (though test kits are also available in the U.K.).

“For sure we’re not replacing a doctor here,” says CEO and co-founder Hana Janebdar, in a call with TechCrunch. “There’s really two buckets of women, if you like, that tend to join the Juno Study or pre-order a test. And the first woman is someone who wants to be very proactive about her general wellness and wants to know more about her body — and this is one of the best ways that you can learn about your microbes and what that means for your vaginal wellness and your pH etc.

“The other women are women who may have had recurrent bacterial vaginosis or recurrent infections and want to know more about what it is that’s causing it potentially — and so she wants a comprehensive picture of her vaginal microbiome. Because if you go and try and figure out, right now, what is causing your bacterial vaginosis using existing methods of diagnosis they’re not always the most helpful. So while that should always be the first port of call, and women should always go to their doctor when they think they have an issue, this is an incredibly important resource when it comes to wellness for a lot of women.”

“There are 10% of women in America, for instance, who have recurrent bacterial vaginosis — which is just one condition of the vaginal microbiome. And it’s one of the highest recurrent rates in medicine,” she adds. “And partly because the diagnostics are terrible in this space.”

Another of the startup’s investors is life sciences giant Illumina, which is providing the DNA sequencing technology it’s using to analyse the samples, per Janebdar.

“This is the first comprehensive vaginal microbiome test kit that’s available that’s next-generation sequencing-based,” she says of the test kit. “Obviously vaginal testing has existed for a while but no one has really used next-generation sequencing — which is the technology that enables a really comprehensive picture of what all the microbes that are in the vagina are. And that’s what’s needed to A) unravel the vaginal microbiome and its impact on women’s lives and fertility and health, and then B) to give women actually the full picture of what those microbes are.”

“The conditions that have been associated with the vaginal microbiome — like BV, or recurrent yeast infections or even the downstream conditions like pelvic inflammatory disease — they’ve historically been poorly characterized. So the diagnosis that have existed to date have been [poor at determining] when and what women have these conditions and therefore what the best treatments should be,” she adds.

Janebdar says the prevailing scientific understanding has been that a Lactobacillus dominant vaginal microbiome is healthy — but more recent studies suggest a more nuanced understanding is needed.

“What’s become clear in the literature is that maybe that’s not always the case. And also the type of Lactobacilli is important. And also there’s really important differences between the vaginal microbiomes and what healthy might look like for Caucasian women versus African American women, for instance,” she notes.

Her background includes a degree in biology and a masters in biochemical engineering — including specific work on microbiome science. It was via her experience of the research field that she says she realized there was a huge gap in women’s health research.

Juno Bio CEO and co-founder, Hana Janebdar (Photo credit: Juno Bio)

“What really shocked me was that while there was this explosion of research and work and commercialization of the gut microbiome and the soil microbiome and every microbiome under the earth that you could think of, the vaginal microbiome had been relatively ignored,” she says, going back to 2017-18 and her inspiration for the startup.

“It really shocked me because of all the microbiomes the vaginal microbiome was the most readily accessible, the most readily associated with the conditions that could improve women’s lives and there were so many women that have these conditions — it was really a sense of hang on, what is going on? And why is this just so incredibly ignored?” she adds. “This needs to be fixed.

“As an Afghan woman — women’s rights and the fact that women are ignored, and medical health research has been sidelined when it comes to women — it’s a very core part of my actual experience as well.”

Juno Bio’s ultimate goal is to gather enough data and understanding to be able to offer “microbial interventions” that can be used to correct problematic imbalances, per Janebdar.

“One of the saddest things… is the fact that microbial interventions could work but having it in this wishy-washy, probiotic, kombucha land has meant that people haven’t fully realized its real potential — and it’s really exciting that in the gut microbiome space, which is analogous to us, first the first time this year you’re seeing sort of phase three approved microbial interventions for the gut. So I see the vaginal space as analogous to that. And this is the kind of stuff that the Juno data-sets will unlock.”

Those shelling out to donate their vaginal microbiome data to Juno Bio’s repository are promised it will be “anonymized” — though clearly links will be retained to some individual data points, such as age and ethnicity.

The startup’s privacy policy can be found here — where it writes: “The information we use in Research is often summarised, aggregated, or combined across a group of subjects to minimize the chance of identification.”

“In the event we require use of individual-level Personally Identifiable Information in Research or for other purposes, we will reach out to you and obtain specific consents applicable to such other use,” it adds.

Juno Bio is being advised by Dr Gregory Buck, Ph.D., who was the principal investigator on the Vaginal Human Microbiome Project (VaHMP) and the Multi Omic Microbiome Study Pregnancy Initiative (MOMS PI) — two studies that were part of the U.S. National Institutes of Health Human Microbiome Project.

Commenting in a statement about the launch of the test kit, Buck said: “While previous studies have worked to characterize the vaginal microbiome, these studies have often been limited in population size, utilize limited gene sequences and lack metadata. As a result, present studies now lack data and a comprehensive strain bank of vaginally associated microbes. Having dedicated much of my career to researching microbiomes of the female reproductive tract, I am confident that the Vaginal Microbiome Test will create one of the richest research repositories of data for future research into vaginal health and related issues. Not only that, but it will help change the stigma around vaginal wellness for the better.”

Source: New feed

2020-09-30T13:00:13+00:00
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