This Breast Cancer Awareness Month, women across the U.S. can now access FDA-authorized, AI-driven assessment of future breast cancer risk

Everlywell, the leader in digital health, diagnostics and virtual care, today announced the nationwide launch and commercial availability of Clairity Breast on its consumer platform.

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Clairity Breast is the first FDA-authorized AI-driven software that can assess a woman's five-year risk of developing breast cancer from a routine screening mammogram. Together with Everlywell's real-world, nationwide reach, the partnership gives women across the U.S. more information about their future breast cancer risk. The partnership also brings together two female-founded, female-led companies: Clairity, founded by Dr. Connie Lehman, and Everlywell, founded by Julia Cheek. Together, they’re making first-of-its-kind breast cancer risk insights more accessible to women nationwide.

“The information we need to understand a woman's breast cancer risk has been in her mammogram all along – we just haven't been able to interpret it until Clairity Breast. Now, it can also inform conversations with your healthcare provider about the best screening and risk reduction options for you,” said Dr. Connie Lehman, Founder and Chief Executive Officer of Clairity and professor of radiology at Harvard Medical School.

About 85% of breast cancers occur in women with no family history of the disease at all. Understanding future risk can give women and their providers more information to help guide care. Clairity Breast gives women a new way to understand their future risk using their routine mammogram rather than family history alone. Clairity Breast has the potential to change how we identify women at elevated risk and to access risk-informed care.

"Women deserve clear answers about their health, and access to the most advanced tools in health care, not years from now, but today. That belief is why I built Everlywell, and it's why we're so proud to partner with Clairity Breast,” said Julia Cheek, Founder and CEO of Everlywell. “This partnership expands access to cutting-edge preventive care, and that means a woman can learn more about her future breast cancer risk from the mammogram she already gets, and walk into her doctor's office with information she's never had before."

In 2025, Clairity Breast became the first AI-based tool to receive FDA De Novo authorization for predicting a woman’s five-year breast cancer risk from a standard screening mammogram. In 2026, updated NCCN guidelines introduced AI-based mammogram risk assessment as an option for identifying women at increased risk beginning at age 35. Clairity Breast is included in the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis. Until now, Clairity Breast has had limited availability through health systems, including Beth Israel Deaconess Medical Center in Massachusetts and Invision Sally Jobe in Colorado.

Now, due to Clairity’s commercial distribution with Everlywell, patients across the U.S. with a qualifying recent screening mammogram from the past 12 months will be able to access the FDA-authorized AI risk assessment through the Everlywell platform. This includes review and ordering by a licensed provider in Everlywell’s affiliated clinician network, and results reviewed and released by a licensed provider with next steps based on national guidelines. A woman can share her result with her own provider to inform her screening and risk-reduction plan, and the Everlywell clinical team is always available to address questions a consumer may have about their Clairity Breast result.

Clairity Breast joins Everlywell's growing cancer screening and risk assessment portfolio, which includes at-home collection colon cancer screening, the recently launched at-home HPV self-collection kit for cervical cancer screening, and access to multi-cancer early detection testing. Clairity Breast does not screen for or detect cancer; it estimates a woman’s future risk so that she and her provider can plan the screening and risk reduction options best suited for her individual risk profile. For over a decade, Everlywell has been empowering women to better understand their health through accessible diagnostic testing and clear, actionable insights. Since its founding Everlywell has delivered nearly one billion personalized health insights and transformed care for over 60 million people.

Learn more and access the Clairity Breast Cancer 5-Year Risk Assessment on the Everlywell platform here.

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 lab 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 lab 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.

About Clairity Breast

Clairity Breast is FDA-authorized AI-driven software that estimates a woman’s risk of developing breast cancer over the next five years from a standard screening mammogram. It received FDA De Novo authorization in May 2025 and is included in the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis. Clairity Breast was validated in more than 77,000 screening mammograms at five U.S. sites for FDA authorization, and in more than 120,000 screening mammograms across 10 U.S. facilities after authorization. It is available through health systems and, as of October 1, 2026, online through Everlywell.

About Clairity

Clairity is a medical technology company focused on advancing cancer risk assessment through artificial intelligence and computer vision. Clairity’s platform can uncover subtle patterns in routine mammogram images that are invisible to the human eye, helping clinicians and their patients to better understand future cancer risk and support more personalized prevention strategies. Clairity’s mission is to shift the standard of care from late-stage treatment to proactive risk-informed prevention. To learn more, visit www.clairity.com.

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About 85% of breast cancers occur in women with no family history of the disease at all. Understanding future risk can give women and their providers more information to help guide care.