Overview
Everly Health provides at-home health testing kits for individuals and enterprises. Customers collect samples (blood, urine, or saliva) at home and mail them to partner labs for analysis, with physician-reviewed results. The tests cover areas such as food sensitivity, fertility, hormones, and infectious diseases (including COVID-19); the company also offers rapid COVID-19 antigen tests for workplaces and other settings. Its goal is to make health testing accessible, actionable, and fast with clear results and compliant testing.
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About Everly Health
Industries
Company Size
201-500
Company Stage
Private
Total Funding
$255.5M
Headquarters
Austin, Texas
Founded
2015
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Simplify's Take
What believers are saying
- NCCN included Clairity Breast in 2026 breast-screening guidance, boosting clinical legitimacy.
- NCQA MY2026 cervical-screening updates align directly with Everlywell's September 2026 HPV launch.
- At-home cancer-risk and screening products target overdue patients, health plans, and enterprise buyers.
What critics are saying
- Clairity Breast costs $249 and lacks insurance coverage, limiting mainstream adoption immediately.
- FTC's January 2024 COVID-19 refund settlement exposed advertising risk and compliance weakness.
- Function Health and Quest Diagnostics pressure Everlywell on broader panel breadth and credibility.
What makes Everly Health unique
- Everlywell commercialized Clairity Breast nationwide on October 1, 2026.
- Everlywell partnered with Waters in September 2026 for FDA-cleared at-home HPV screening.
- Its clinician network combines testing, telehealth follow-up, and referrals in one workflow.
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Funding
Total Funding
$255.5M
Above
Industry Average
Funded Over
7 Rounds
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Mental Health Support
- 401(k) Retirement Plan
- 401(k) Company Match
- Unlimited Paid Time Off
- Wellness Program
Growth & Insights and Company News
6 month growth
0%1 year growth
0%2 year growth
-11%The mammogram has been looking for cancer, and now AI is asking what comes next. TL;DR - Key Takeaways - Clairity Breast uses AI to analyze routine screening mammograms and estimate a woman's risk of developing breast cancer within five years. - The FDA authorized the technology in 2025 as an AI-based tool specifically designed to assess future breast cancer risk from mammograms. - Unlike traditional risk models that rely on factors such as age, family history and breast density, Clairity analyzes patterns within the mammogram itself. For decades, estimating a woman's likelihood of developing breast cancer has meant assembling a collection of possible indicators, including her family history, reproductive history, breast density, previous biopsies and, in some cases, genetic testing. Those factors can identify women at elevated risk, but they still cannot tell an individual woman whether cancer is waiting somewhere in her future. Now, an AI tool is looking for another set of clues, inside the mammogram itself. Clairity Breast analyzes a routine screening mammogram to estimate the likelihood that a woman will develop breast cancer within the next five years. In 2025, it became the first AI-based tool authorized by the U.S. Food and Drug Administration specifically to predict future breast cancer risk from a standard screening mammogram. On Oct. 1, 2026, Clairity expanded access to the technology nationwide through a partnership with digital health company Everlywell. "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," said Dr. Connie Lehman, Clairity's founder and CEO and a professor of radiology at Harvard Medical School. "Now, it can also inform conversations with your healthcare provider about the best screening and risk reduction options for you." The American Cancer Society estimates that about 322,000 women in the United States will be diagnosed with invasive breast cancer in 2026, and more than 42,000 will die from the disease. Breast cancer accounts for roughly one-third of new cancers diagnosed in American women, excluding skin cancers. According to the National Cancer Institute, the median age at breast cancer diagnosis is 63. Worldwide, breast cancer is the most commonly diagnosed cancer among women. The International Agency for Research on Cancer estimates that about 2.3 million women are diagnosed with the disease globally each year. According to the American Cancer Society, more than 85% of women diagnosed with breast cancer have no family history of the disease. Medicine has spent decades trying to pinpoint who is more likely to develop breast cancer. One of the best-known tools is the Gail Model, formally called the Breast Cancer Risk Assessment Tool. Developed by researchers at the National Cancer Institute and the National Surgical Adjuvant Breast and Bowel Project, it considers factors including age, reproductive history, previous breast biopsies and breast cancer among first-degree relatives to estimate a woman's five-year and lifetime risk. The Tyrer-Cuzick model incorporates a more extensive family history along with hormonal, reproductive and other factors. The Breast Cancer Surveillance Consortium model includes breast density, age, race and ethnicity, family history and previous breast biopsy results in estimating risk. These methods construct a forecast from what is known about the woman. Clairity is attempting to derive part of that forecast from what is contained in the breast image itself. The software analyzes pixel-level features and patterns within a standard bilateral screening mammogram, searching for characteristics associated with women who subsequently developed breast cancer. The result is a percentage representing the estimated probability of developing the disease within five years. According to Clairity, its model showed a 30% improvement in discrimination compared with traditional risk models. The FDA authorized the technology, originally submitted under the name Allix5, in May 2025. According to Clairity, it was validated for FDA authorization using more than 77,000 screening mammograms from five U.S. sites and subsequently validated using more than 120,000 mammograms across 10 U.S. facilities. This does not mean AI can peer five years into the future and see a tumor forming. Clairity Breast is a risk-assessment tool, not a prediction of what will happen to a particular woman. Someone receiving an elevated score may never develop breast cancer, while someone with a lower score still could. It also does not replace a radiologist. According to the FDA, Clairity Breast is not intended to detect or diagnose breast cancer, interpret a mammogram or determine treatment. Instead, its five-year risk estimate provides another piece of information that a woman and her health care provider can consider when discussing screening and risk-reduction strategies. The approach is also beginning to enter mainstream clinical guidance. The 2026 National Comprehensive Cancer Network guidelines include AI-based mammogram risk assessment as an option for identifying women at increased breast cancer risk beginning at age 35. Until recently, access to Clairity Breast was limited largely to participating health systems, including Beth Israel Deaconess Medical Center in Massachusetts and Invision Sally Jobe in Colorado. Through Everlywell, women nationwide with a qualifying screening mammogram from the previous 12 months can now request the assessment. The $249 service includes ordering and review through licensed providers affiliated with Everlywell, and the results can be shared with a woman's own physician. "Women deserve clear answers about their health, and access to the most advanced tools in health care, not years from now, but today," said Julia Cheek, Everlywell's founder and CEO. "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." Clairity Breast is also part of a broader movement in medical AI, one centered on extracting information from familiar tests that clinicians were never able to see. Researchers are doing something similar with electrocardiograms. AI systems trained on millions of ECGs and associated patient outcomes are learning to recognize subtle electrical patterns associated with heart failure, valve disease and other conditions, signals that may be too faint or complex for even an experienced cardiologist to identify consistently. Mammograms may hold similarly unexpected information. In a recent study, researchers in Israel used AI to analyze 97,364 mammograms from 29,921 women, not for breast cancer, but for patterns associated with cardiovascular disease. The AI identified women with a history of stroke 86% of the time and distinguished women with high blood pressure and coronary heart disease from those without those conditions with reported accuracies of 79% and 78%, respectively. The research suggests that medical images routinely collected for one purpose may contain biological information about something entirely different. Instead of requiring another scan or test, AI can potentially return to an image already sitting in a patient's medical record and ask questions that the image was never originally intended to answer.
Everlywell has launched Clairity Breast nationwide on its consumer platform, making FDA-authorised AI-driven breast cancer risk assessment accessible across the US. The software analyses routine screening mammograms to assess a woman's five-year risk of developing breast cancer. Clairity Breast became the first AI-based tool to receive FDA De Novo authorisation for predicting breast cancer risk in 2025. It is now included in NCCN Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis. The partnership brings together two female-founded companies: Clairity, founded by Dr Connie Lehman, and Everlywell, founded by Julia Cheek. Previously available only through select health systems, patients with a qualifying mammogram from the past 12 months can now access the assessment through Everlywell's platform. The tool estimates future risk rather than detecting cancer, helping women and providers plan appropriate screening strategies.
Everlywell appoints Charles Cuzzell as Chief Commercial Officer and Mike Considine as Chief Product Officer to accelerate enterprise expansion. September 24, 2026 at 10:00 AM EDT i This article is third-party content and does not represent the views of this site. Tamar Securities, LLC make no guarantees regarding its accuracy or completeness. Now working with four of the five largest U.S. health plans, the company's enterprise division is positioned for significant growth Everlywell, the diagnostics and virtual care platform powering preventive and chronic care for the nation's largest health plans, today announced continued investment in its enterprise business with the additions of Charles Cuzzell as Chief Commercial Officer and Mike Considine as Chief Product Officer. The company, best known for putting diagnostic testing in consumers' hands, has now become a trusted partner in providing both remote diagnostics and virtual care for health plans covering 170 million Americans. Over the past decade, Everlywell has harnessed advanced diagnostics to deliver nearly one billion personalized health insights, transforming care for 60 million people and powering hundreds of enterprise partners. The company is now scaling its wrap-around care model, which includes member engagement, at-home lab testing, and NCQA-accredited virtual care. "Health plans don't buy point solutions anymore; they buy partners who are accountable for the full care pathway and can reliably help them engage members, improve outcomes, and drive quality metrics," said Julia Cheek, Founder and CEO of Everlywell. "We've spent a decade building the at-home lab testing and virtual care infrastructure that make us a key partner to the largest payers. Charles and Mike are here to scale the enterprise commercial organization and deliver AI-driven data and care solutions that payers and health systems actually deploy." The Preventive Care Opportunity for Health Plans Only a fraction of adults complete the preventive services recommended for them, and the gap holds across every population a plan manages. Federal data show that just 7.2% of adults aged 35 and older receive all high-priority preventive services, a problem reflected in medical costs and quality scores alike. Everlywell's enterprise growth is concentrated in cardiometabolic health and cancer screening, the categories where plans carry some of the highest medical costs and the heaviest quality-score weighting. The platform supports more than 25 HEDIS measures, including: * GSD (Glycemic Status Assessment for Patients with Diabetes) * KED (Kidney Health Evaluation for Patients with Diabetes) * CBP (Controlling High Blood Pressure) * COF-E (Follow-Up After Positive Colorectal Cancer Non-Invasive Screening Test) * CCS-E (Cervical Cancer Screening) Last year, the company introduced Eva, an AI-powered platform that translates complex biomarker data into clear, personalized health insights and helps health plans engage members with timely outreach, coordinated care pathways, and actionable next steps. Most recently, Everlywell partnered with Waters Corporation to offer the Onclarity(TM) HPV Self-Collection Kit, tested with the BD Onclarity(TM) HPV Assay, the most comprehensive FDA-cleared at-home HPV cervical cancer screening tool available in the U.S. today.[1] The diagnostic-led solution helps health plans expand access to cervical cancer screening and makes it easier for eligible members to complete recommended preventive care. Expanding Everlywell's Leadership Team As Chief Commercial Officer, Cuzzell owns Everlywell's enterprise organization end-to-end, including sales, partnerships, account management, and customer success. "I'm excited to join Everlywell and build on the important work already underway to help health plans engage members, close care gaps, and make high-quality preventive care easier to access," said Charles Cuzzell, Chief Commercial Officer of Everlywell. "Everlywell's platform brings together diagnostics, digital engagement, and connected care to help payers and employers reach members with timely, actionable health insights and clear next steps. I look forward to building a commercial organization ready to meet that need at scale." As Chief Product Officer, Considine leads product and design across the company. "Throughout my career, I've focused on building products that turn complex healthcare data into clearer decisions and better action," said Mike Considine, Chief Product Officer of Everlywell. "Everlywell is uniquely positioned to connect advanced diagnostics with a digital experience that helps individuals understand what their results mean and what to do next. I'm excited to advance a product strategy that makes that experience simpler, more personalized, and easier for health plans to deliver at scale." To learn more about Everlywell and the company's enterprise solutions, 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 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 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. [1] There are currently two FDA-approved HPV tests with extended genotyping with different configurations. The BD Onclarity(TM) HPV Assay individually identifies 6 high-risk HPV genotypes and strategically groups 3 results for 8 moderate risk HPV genotypes. Over the past decade, Everlywell has harnessed advanced diagnostics to deliver nearly one billion personalized health insights, transforming care for 60 million people and powering hundreds of enterprise partners. Contacts. Report this content If you believe this article contains misleading, harmful, or spam content, please let Tamar Securities, LLC know.
Everlywell has partnered with Waters Corporation to offer the Onclarity HPV Self-Collection Kit, described as the most comprehensive FDA-cleared at-home HPV cervical cancer screening tool available in the US. The diagnostic solution aims to help health plans expand access to cervical cancer screening for eligible members. The American Cancer Society estimates over 13,000 new invasive cervical cancer cases will be diagnosed in the US this year. One in four women are not up to date with testing, and roughly half of diagnosed women have never been screened or are overdue. Members collect samples at home and send them to a CLIA-certified laboratory. Results are delivered digitally through Everlywell's platform, with telehealth consultations and in-person referrals available for abnormal results.
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(TM) HPV Self-Collection Kit, tested with the BD Onclarity(TM) 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. "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." Share 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(TM) HPV Self-Collection Kit is tested with the BD Onclarity(TM) 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(TM) 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(TM) 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 More News From Everlywell AUSTIN, Texas-( BUSINESS WIRE )-Everlywell, a leader in digital health, today reported new insights from Eva Engage, the personalized outreach capability within Eva, its AI health companion launched earlier this year. Eva is powered by three core engines, Eva Engage, Eva Care, and Eva Support, that create an intelligent, connected care experience, helping individuals take meaningful action for their health. Eva Engage is more proactive, timely, and deeply personal than traditional outreach. Its... AUSTIN, Texas-( BUSINESS WIRE )-Everlywell, a leader in digital health, today announced the launch of Eva - an AI-powered platform that turns complex biomarker data into easy-to-understand, personalized health insights. Eva combines intelligence with engaging tools to guide and motivate individuals to take meaningful action for their health. Eva is an intelligent health companion that helps personalize crucial touchpoints with smart recommendations and insights throughout the healthcare journey,... RESEARCH TRIANGLE PARK, N.C.-( BUSINESS WIRE )-The American Sexual Health Association (ASHA), America's nonprofit authority for sexual health information, is launching its inaugural National Get Tested Day on September 30 to advance the conversation around sexual health and break down barriers to accessing this essential health care. On the launch of National Get Tested Day, ASHA is partnering with Everlywell, a leader in at-home STI lab testing and treatment, to give away 250 free Everlywell a... Everlywell. Release Versions
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About Everly Health
Industries
Company Size
201-500
Company Stage
Private
Total Funding
$255.5M
Headquarters
Austin, Texas
Founded
2015
Everly Health is Hiring for 14 Jobs on Simplify!
Find jobs on Simplify and start your career today