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Precision care for vaginal health via metagenomic sequencing

Article-Precision care for vaginal health via metagenomic sequencing

© AdobeStock/StockPhotoPro Precision care for vaginal health via metagenomic sequencing
US startup Evvy uses metagenomics to sequence the vaginal microbiome via an at-home swab test, allowing women to personalise their health care plan. “We're interested in building a new understanding of the female body,” it says.

Evvy co-founders Priyanka Jain and Laine Bruzek spent 18 months developing and validating a vaginal microbiome test that they say is “pioneering precision care for vaginal health”. Users send a swab sample and receive results along with a customised plan of science-backed recommendations – such as taking a specific probiotic or antibiotic – and one-on-one coaching.

According to Evvy, which raised $5 million in a seed round in 2021, its comprehensive testing makes it stand out from the crowd. The startup screens for all the disruptive and protective microbes that scientific research have shown are related to common problems.

Leveraging ‘overlooked biomarkers’ in the female body

We are a vaginal microbiome company. But more broadly than that, we're really interested in building a new understanding of the female body,” said Amelia Marran-Baden, head of branding.

Just to give one statistic, in the United States, women weren't required to be included in clinical trials until 1993. There's this massive data gap in our understanding of how the female body functions and how it will react to different drugs and treatments. And so, Evvy is really on a mission to narrow that gap [...] by discovering and leveraging overlooked biomarkers in the female body, and give people the education and information [to] make informed decisions.

The bacteria that Evvy screens for include those associated with aerobic vaginitis, such as Escherichia coli and group B streptococci; bacterial vaginosis, such as Gardnerella vaginalis, Atopobium vaginae, and Prevotella bivia; cytolytic vaginosis, such as Lactobacillus crispatus; recurrent urinary tract infections, such as E. coli, Klebsiella, and group B streptococci; and yeast infections, such as Candida albicans, Candida glabrata.

It also screens for bacteria associated with good health, such as Lactobacillus gasseri and Lactobacillus jensenii. (It does not test for parasites, viruses, or sexually transmitted diseases.)

A high-fidelity picture of the microbiome

The use of metagenomics to sequence the vaginal microbiome gives a “high-fidelity picture of the bacteria and fungi” that are present as well as their relative amounts, said Marran-Baden, offering a level of detail that has been missing up until now.

Instead of just isolating one disruptive or protective microbe, like you might get on a PCR test, for example, it's really giving you a full picture of what's going on, and [that] allows you to understand what the best plan is for your specific body,” she said.

We're really trying to personalise this. A lot of people think, ‘I have vaginal symptoms, a probiotic is good for me’. But if you have a lot of protective bacteria and a lot of strains of lactobacilli, a probiotic might actually make symptoms worse before making it better.

© AdobeStock/Dr_Microbe3D illustration of Gardnerella vaginalis bacteria

3D illustration of Gardnerella vaginalis bacteria

The startup recently began an integrative clinical care plan for eligible tests, whereby it works with affiliated doctors who can issue a prescription if required. It also has several academic partnerships; a scientific advisory committee composed of board-certified gynaecologists and professors; and is building a longitudinal dataset to glean insights into how microbiomes change over time.

This dataset will improve understanding of the vaginal microbiome, enabling Evvy to predict treatment response for varying interventions on different patient profiles. Evvy customers have the choice to opt in or out of this research when signing up.

Two-month pilot study: 71% average reduction of disruptive bacteria

The New York-headquartered startup, which offers its services throughout the US, recently designed and conducted a small study, approved by an institutional review board (IRB), with 23 participants to evaluate the effectiveness of its treatment programmes.

After two months, there was a 71% average reduction of disruptive bacteria and 68% average increase of protective bacteria, while all participants said their symptoms improved.

There was also an improvement in perceived quality of care. While prior to starting Evvy treatment, only 4% of surveyed women said they felt understood and none felt like they had access to the right care and resources, this rose to 96% and 100% respectively.

‘We're not just another antibiotic’

The vaginal microbiome – just like the gut microbiome – is hugely sensitive to environmental factors.

Growing numbers of women are aware that taking a course of antibiotics can destroy the vaginal microbiota but there are other, less obvious changes that can also have an impact. Using a new shampoo that contains synthetic chemicals and fragrances, for instance, may trigger vaginal microbiome dysbiosis as the foam mixes with shower water and runs down the body.

Stress, fatigue, or illness can also cause changes in the vaginal microbiome. Due to this continually changing state, Evvy recommends that users take the test every three months or as symptoms evolve.

© AdobeStock/MikhaylovskiyHealthy uterus concept

As for next steps, the startup plans on investigating how food is linked to a healthy, balanced vaginal microbiome.

CEO Priyanka Jain told Vitafoods Insights: “We are focused on validating that having comprehensive vaginal microbiome data improves diagnoses and selection of the correct treatment pathways, and validating that our care pathways continue to improve vaginal health outcomes. We are also researching more detailed definitions of health and disease in a wide range of people, and the mechanisms by which people move between them.

As we [do this], we hope to gain a better understanding of the specific treatments and foods that are most likely to improve or maintain a specific person's vaginal microbiome.

According to Marran-Baden, the personalisation of care is “a huge step in the right direction” for women’s health.

We're not just another antibiotic; it's personalised and it takes into the account all of you, from your test results to your health history. And this empowers our affiliated [doctors] to provide women with exactly the right treatment programme,” she said.