Everlywell Announces a Partnership with Waters Corporation to Bring the Most Comprehensive FDA-Cleared At-Home HPV Cervical Cancer Screening Tool Available in the U.S. Today to Patients

New partnership delivers a diagnostics-led care that helps plans engage eligible members and connect women to appropriate follow-up care, consultation, and in-person referrals

AUSTIN, Texas--(BUSINESS WIRE)--Everlywell, a leader in digital health, today announced a partnership with Waters Corporation to ensure patients have access to the most comprehensive at-home HPV cervical cancer screening tool available in the U.S. today, the Onclarity™ HPV Self-Collection Kit, tested with the BD Onclarity™ HPV Assay.¹ The new diagnostic-led solution supports health plans as they expand access to cervical cancer screening and make it easier for eligible members to complete recommended preventive care.

The American Cancer Society estimates that over 13,000 new invasive cervical-cancer cases will be diagnosed in the U.S. this year.² While screening and HPV vaccination have improved diagnosis over time, screening gaps remain substantial, with one in four women not up to date in testing. In fact, roughly half of women diagnosed with cervical cancer have never been screened or are overdue for a test. However, these cancers rarely occur in women who have been getting regular tests to screen for cervical cancer before the age of 65.² Members can collect the sample at home and send it back to a CLIA-certified laboratory. Results are delivered digitally through the Everlywell platform, and clinical follow-up is available via telehealth consultation, with in-person referral for further evaluation for members with abnormal results.

“Every woman deserves a clear and accessible path to understand her health and take the next right step. The new partnership expands access to screening, and connects women to appropriate follow-up care,” said Julia Cheek, Founder and CEO of Everlywell. “By bringing together outreach, convenient screening access, clinician-guided results, and connected care systems, we can help plans close care-gaps while preparing for the next generation of women’s preventive care.”

Everlywell is among the first to market with an FDA-cleared, at-home HPV testing solution in direct response to the NCQA MY2026 update. Cervical Cancer Screening–Electronic Clinical Data Systems (CCS-E) remains one of the more difficult preventive screening measures to improve because traditional screening requires an in-person visit. At-home testing expands access to members who are overdue, difficult to reach, or reluctant to complete in-office screening. By connecting screening activity with care pathways, the solution is designed to help plans address CCS-E care gaps, and prepare for updated federal preventive-services guidance taking effect in 2027.

Everlywell’s HPV Test is part of the platform’s broader effort to expand access to cancer screening, women’s health insights and preventive care. Everlywell’s consumer and enterprise offerings span a variety of cancer screenings, cardiometabolic screenings, fertility-related testing, hormone and thyroid biomarkers, and sexual-health testing, with results designed to help eligible individuals understand their information and pursue appropriate medical follow-up when needed.

The Onclarity™ HPV Self-Collection Kit is tested with the BD Onclarity™ HPV Assay, which detects 14 high-risk HPV genotypes to identify oncogenic risk and is the only FDA-approved HPV assay to identify six individual genotypes and three groups of pooled results, making it the most comprehensive HPV screening tool available in the U.S. today.¹

For more than a decade, Everlywell has pioneered direct empowerment of consumers and health plan members to take control of their own health, combining AI-powered technology with human insight, advanced diagnostics, virtual care, and patient engagement to help people better understand their health and take informed and actionable next steps.

To learn more about Everlywell and access to the Onclarity™ HPV Self-Collection Kit, visit https://www.everlywell.com/enterprise.

About Everlywell

Everlywell is a digital health company transforming complex biomarker data into life-changing insights—seamlessly integrating advanced diagnostics, virtual care, and patient engagement to expand access, close care gaps, and improve health outcomes across the full care journey. Through at-home and clinician-supported testing and virtual care experiences, Everlywell empowers individuals with the information they need to make more informed health decisions.

Over the past decade, Everlywell has delivered nearly one billion personalized health insights, transformed care for 60 million people and powered hundreds of enterprise partners, including four of the top five largest health plans in the U.S. that cover 170 million insured lives. In 2025 alone, an estimated one in 94 U.S. households received an Everlywell test, solidifying its spot as the #1 at-home testing brand in the country. Fueled by AI and built for scale, Everlywell is breaking down barriers, closing care gaps, and unlocking a more connected healthcare experience that is smarter, faster, and more personalized. Learn more at everlywell.com.

Disclaimer:
The BD Biosciences and BD Diagnostic Solutions businesses have been acquired by Waters Corporation ("Waters"). Becton, Dickinson and Company or one of its affiliates or subsidiaries ("BD") remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains full responsibility for all regulatory obligations of the legal manufacturer. Product information provided here is supplied under BD's regulatory authority. To learn more about the relationship between Waters and BD during this transition period, please see our detailed summary: www.waters.com/bdtransaction.

¹ There are currently two FDA-approved HPV tests with extended genotyping with different configurations. The BD Onclarity™ HPV Assay individually identifies 6 high-risk HPV genotypes and strategically groups 3 results for 8 moderate-risk HPV genotypes.
² https://www.cancer.org/cancer/types/cervical-cancer/about/key-statistics.html