Evvy Announces the Company’s First Chief Medical Officer and Publishes Peer-Reviewed Validation on the Evvy Vaginal Health Test, Advancing its Mission of Unlocking Precision Female Healthcare

Evvy Names Dr. Kate McLean, MD, MPH, FACOG as Chief Medical Officer, publishes peer-reviewed validation paper for its at-home vaginal microbiome test in the Diagnostics journal, and presents novel discoveries from the Evvy platform at leading clinical conferences.

NEW YORK, Oct. 17, 2024 /PRNewswire/ — Evvy, a female-founded biotech startup, announces significant milestones in driving the future of precision female healthcare:

• Evvy appoints industry veteran Kate McLean, MD, MPH, FACOG as the company’s first Chief Medical Officer.
• Evvy published peer-reviewed validation of its CLIA, CAP, and CLEP-certified Vaginal Health Test in the prestigious Diagnostics journal, highlighting its industry-leading sensitivity of 93.1 percent and specificity of 90 percent across 700+ microbes.
• Evvy presented novel discoveries from their data platform at three major clinical conferences related to vaginal health in the past year (the Infectious Disease Society of ObGyn, the International Society of Women’s Sexual Health and the International Society for the Study of Vulvovaginal Diseases).

“As shown by our robust validation and novel discoveries, we’re entering a pivotal era for Evvy as we elevate the standards of women’s healthcare through precision science,” said Priyanka Jain, CEO and Co-Founder of Evvy. “We are thrilled to welcome Dr. Kate McLean to our team. Not only does she share our vision, but she brings deep expertise that will accelerate our ability to leverage comprehensive testing and AI to deliver the personalized, proactive, and empathetic healthcare that women deserve.

Evvy Announces Dr. Kate McLean as Chief Medical Officer
From serving as the Chair for the American College of OBGYNs (ACOG) in Washington state, to providing on-the-ground care for women in Tanzania, to advancing precision medicine at leading digital health companies, Dr. McLean brings a breadth of experience to Evvy. Her strong track record will accelerate Evvy’s goals of expanding offerings for patients, uncovering new biomarkers within Evvy’s novel dataset, and building strategic partnerships with leading researchers and providers.

“As an OBGYN, I’ve seen up close how the lack of research in women’s health profoundly affects patient outcomes worldwide. As a healthtech leader, I’ve also seen the transformative power of technology and data to gather data, personalize care, and change lives at scale,” said Dr. Kate McLean, the new Chief Medical Officer of Evvy. “‘I’m excited to join Evvy, the clear leader in transforming women’s health through data. Together, we will continue to empower patients and clinicians with comprehensive insights, while pushing the boundaries of scientific discovery to improve outcomes in fertility, pregnancy, gynecological cancers, menopause, and beyond.”

Dr. McLean began her career in women’s health at Lake Tanganyika Floating Health Clinic, where she worked in Tanzania as Chief Program Officer. After returning to the US to practice as an OBGYN at the University of Washington, she became the Chief Medical Officer at Quilted Health, a leading midwife care company providing virtual and in-person care for pregnancy, postpartum, and beyond. Most recently, Dr. McLean served as the Senior Director of Clinical Product Strategy at Ro, where she played a pivotal role in scaling its robust offerings across men’s and women’s health, including its first ever at-home fertility test. She has also been advising a joint project with the Gates Foundation to develop AI-guided obstetrical tools and continues her leadership role within ACOG as the Legislative Chair for Washington State. Her extensive experience as a practicing OBGYN, combined with her work developing innovative healthcare platforms, ultimately led her to joining Evvy.

Peer-reviewed Validation of the Evvy Vaginal Health Test
The rigorous validation of Evvy’s Vaginal Health Test was recently published in the peer-reviewed Diagnostics journal Special Issue Applications of Next-Generation Sequencing Technologies for the Diagnosis and Management of Infectious Diseases.

The validation analyzed over 7,000 vaginal microbiome samples and demonstrated the test’s exceptional sensitivity (93.1 percent) and specificity (90 percent). Unlike traditional diagnostic methods that test for a limited number of pathogens, Evvy’s test uses advanced shotgun metagenomic sequencing to analyze over 700 species of bacteria and fungi from a single, at-home swab. This comprehensive analysis helps clinicians make more informed decisions based on a complete understanding of each patient’s microbial composition.

Evvy’s Vaginal Health Test test is the first and only CLIA, CAP, and CLEP-certified vaginal microbiome test. With this robust, peer-reviewed validation, the Evvy Vaginal Health Test continues to set a new standard for vaginal microbiome testing, empowering clinicians to leverage cutting-edge science to guide personalized care for a leading reason that women seek healthcare advice.

Evvy’s Novel Data Transforming Care Worldwide
Evvy presented novel discoveries at three medical conferences related to vaginal health in the past year, including the Infectious Disease Society of ObGyn, the International Society of Women’s Sexual Health and the International Society for the Study of Vulvovaginal Diseases.

The insights presented at these conferences highlight the way that Evvy’s novel data will continue to close gaps in knowledge and care related to women’s health. The presentations included:

• The presence of aerobes (oxygen-loving organisms) in vaginitis patients results in a greater number and severity of symptoms. (Infectious Disease Society of ObGyn 2023)
• Differences in the pathogenicity genes in the genomes of Gardnerella in the vaginal microbiome. (Infectious Disease Society of ObGyn 2023)
• Women who report pain with sex have different vaginal microbiome profiles in menopause vs reproductive-age. (International Society of Women’s Sexual Health 2024)
• Candida albicans can be present in women with high relative abundance of Lactobacillus with or without symptoms. (International Society for the Study of Vulvovaginal Diseases 2024)
• Vaginal odor is associated with increased abundance of specific microorganisms. (Infectious Disease Society of ObGyn 2024)

All of the above milestones demonstrate Evvy’s progress in leveraging novel female biomarkers to improve care and outcomes in women’s health. Over the past year, Evvy raised $14M in its series A funding round, introduced an STI test that detects four common infections, and celebrated its third annual Equal Research Day by partnering with 46 healthtech companies to raise awareness for gender inequalities in medical research & care. As part of this initiative, Evvy launched a limited-edition coffee table book, 100 Effed Facts About the Gender Health Gap, with proceeds going toward Women’s Health Access Matters (WHAM) to help accelerate women’s research and funding.

To learn more about Evvy and its offerings, please visit https://www.evvy.com/.

About Evvy:
Evvy is closing the gender health data gap by leveraging overlooked female biomarkers, starting with the vaginal microbiome. The Evvy Vaginal Health Test is the world’s first CLIA, CAP, and CLEP-certified, at-home vaginal microbiome test, testing for 700+ bacteria and fungi with a single swab, including those related to bacterial vaginosis, yeast infections, recurrent UTIs and much more. Evvy’s larger vaginal healthcare platform is the first to combine state-of-the-art microbiome testing, precision clinical care, and coaching to give women and people with vaginas the care they deserve. Through this platform, Evvy is building real-world datasets that can transform our understanding of complex female health conditions.

Founded by Priyanka Jain, Laine Bruzek, and Pita Navarro, the Evvy team includes scientists, designers, machine learning engineers, and doctors, including a group of leading OB/GYNs, and vaginal microbiome researchers with decades of experience at organizations like UCSF, Stanford, Harvard, and more.

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SOURCE Evvy