Vaginal discomfort is one of the leading reasons women seek healthcare advice, and over 90% of these cases can be 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 as it is based on factors such as a “whiff test” of vaginal odors, a wet mount, and a review of patient symptoms. When point of care DNA testing is leveraged, current clinical tests look for a limited list of 3-10 microbes via binary negative/positive PCR panels, which are unable to provide a complete list of microbes present in the vaginal microbiome.
Without a comprehensive, objective picture of the vaginal microbiome, 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% of bacterial vaginosis and 77% of yeast infection cases were incorrect.
Dealing with vaginal infections can significantly impact both a patients’ quality of life and long term health outcomes. People with yeast infections have a 2.5x higher rate of anxiety than the general population, and people with bacterial vaginosis experience significantly reduced self-esteem, sexual activity, and quality of life. 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.
But even though vaginal infections are highly prevalent, drastically affect quality of life, and can impact long term health outcomes, accessible, comprehensive, and validated vaginal microbiome testing has not been available.
Evvy, a female-founded startup on a mission to close the gender health gap by discovering and leveraging female-specific biomarkers, is now partnering with MicroGenDX, a CLIA/CAP certified laboratory that has been pioneering the use of NGS testing for physicians for over a decade. Evvy and MicroGenDX are teaming up to relaunch the Evvy Vaginal Health Test as the world’s first and only CLIA-validated mNGS vaginal microbiome test. The Evvy Vaginal Health Test leverages mNGS to screen for every microbe isolated from the vaginal and urinary tract (excluding microbes related to reportable STIs). The test was developed and validated at MicroGenDX, the lab in which all samples will be processed.
Evvy’s relaunched Vaginal Health Test was developed and analytically validated at MicroGenDX, the lab in which samples will be processed. The analytical validation was completed with rigorous quality metrics, threshold values, and limits of detection for all reported organisms. The test demonstrated improved analytical sensitivity and specificity over traditional methods — finally bringing in the power and precision of metagenomics to vaginal healthcare.
All results for the Vaginal Health Test are delivered through Evvy’s platform, alongside personalized education and actionable insights based on unique learnings from Evvy’s data. Each test also comes with a 1-1 call with one of Evvy’s certified health coaches. Through accessible testing and straightforward insights that help consumers understand their own vaginal health, the Evvy Vaginal Health Test enables consumers to get an accurate, comprehensive picture of their vaginal microbiome at a transparent price using convenient at-home collection.
“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 personalized, 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 for women and people with vaginas everywhere.”
“At Evvy, we’re committed to leveraging the best technology to provide anyone with a vagina with the most comprehensive, scientifically validated, and personalized information on their vaginal health,” said Priyanka Jain, Co-Founder & CEO of Evvy. “We’re extremely excited about partnering with MicroGenDX to advance the available tools for overlooked, yet highly important women’s health issues.”
“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,” said Rick Martin, CEO of MicroGenDX. “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.”