Evvy teams up with MicroGenDX to relaunch metagenomics-based vaginal health test

The female-founded startup Evvy has announced a partnership with the MicroGenDX laboratory to relaunch vaginal health test.

Evvy and MicroGenDX have partnered to relaunch the Evvy vaginal health test as the world’s first and only CLIA-validated mNGS vaginal microbiome test.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing

The Evvy vaginal health test, developed and validated at MicroGenDX, uses mNGS to screen for every microbe isolated from the vaginal and urinary tract.

The company aims to help consumers understand their own vaginal health and enable them to get a better picture of their vaginal microbiome.

The results for the test are delivered through Evvy’s platform, alongside personalised education and actionable insights.

Vaginal discomfort is one of the leading reasons women seek healthcare advice with over 90 per cent of these cases being attributed to imbalances in the vaginal microbiome.

Despite the high prevalence of vaginitis and the rapid adoption of DNA testing into many other branches of medicine, vaginitis testing remains limited.

Most clinicians diagnose based on the Amsel score criteria, which is oftentimes unreliable and subjective.

Without a comprehensive, objective picture of the vaginal microbiome, Evvy says, it is unsurprising that both physicians and patients often misdiagnose vaginal complaints.

In a study of 220 physician-diagnosed patients with vaginal symptoms, the diagnoses for 61 per cent of bacterial vaginosis and 77 per cent of yeast infection cases were incorrect.

Dealing with vaginal infections can significantly impact both a patients’ quality of life and long term health outcomes, leading to higher anxiety rates and reduced self-esteem.

Additionally, in terms of long term health outcomes, research suggests that imbalances in the vaginal microbiome, such as bacterial vaginosis, can be associated with increased risk of a variety of adverse health outcomes, such as STI acquisition, pelvic inflammatory disease, preterm birth and infertility.

“I’m thrilled that Evvy’s groundbreaking test and educational platform is supported by CLIA validation,” said Dr Rebecca Nelken, OB/GYN and Evvy’s founding physician.

“Patients can get direct access to personalised, scientifically sound education on their bodies, enabling them to participate in shared decision making about their health. Clinicians see a patient’s entire vaginal microbiome composition from one swab that can be collected in the comfort of a patient’s home.

“Vaginal healthcare has been hugely overlooked for decades, and I’m so excited that Evvy is continuing to pioneer a new standard of care.”

Priyanka Jain, co-founder and CEO of Evvy, said: “We’re committed to leveraging the best technology to provide anyone with a vagina with the most comprehensive, scientifically validated, and personalised information on their vaginal health.

“We’re extremely excited about partnering with MicroGenDX to advance the available tools for overlooked, yet highly important women’s health issues.”

Rick Martin, CEO of MicroGenDX, added: “We’ve been committed to bringing NGS testing to improve healthcare outcomes for over a decade, and we’re very excited to partner with Evvy to bring advancements to vaginal health — a field that has been overlooked for too long.

“We’re proud to partner with Evvy to bring their vaginal health test to market, providing answers and hope to the millions of women suffering from vaginitis.”