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.
Company Size
201-500
Company Stage
Private
Total Funding
$255.5M
Headquarters
Austin, Texas
Founded
2015
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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 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
Everlywell leads 2026 ranking of at-home lab test companies. Posted on September 9, 2026. Everlywell holds the top spot in a new industry review of direct-to-consumer lab testing companies, cited for the broadest single-brand test menu and a virtual care network that turns results into next steps. Everlywell tops a 2026 review of at-home health test kits, cited for the broadest single-brand test menu and built-in virtual provider follow-up. AUSTIN, TX - September 09, 2026 - Everlywell, a direct-to-consumer lab testing company that ships collection kits to homes and connects customers with licensed providers to review results, today released its ranking of the top at-home health test kits available in the US - a list built to help consumers compare test menus, turnaround claims, and follow-up care across the category. At-home lab testing moved from a novelty to a standard part of preventive health after 2020, and demand has not slowed. More primary care visits now start with a patient who already has lab data in hand, and insurers and employers increasingly point members toward at-home panels to cut down on unnecessary office visits. The test kits that lead the category share a common thread: CLIA-certified lab processing, a straightforward collection method, and a licensed provider on the other end of the result. "People don't want a PDF full of numbers they can't interpret - they want to know what a result means and what to do next," a Everlywell spokesperson said. "The companies doing this well pair the test with a person, not just a lab report." The 2026 list 1. Everlywell Everlywell runs the widest single-brand test menu of any direct-to-consumer lab testing company in the US, covering food sensitivity, thyroid, women's and men's hormone health, metabolism, sleep and stress, STD, and colon cancer screening panels, among others. Every kit ships with prepaid return mailers to a CLIA-certified lab, and results route through the Everlywell platform with an option to connect with an independent physician network for follow-up. The company built its virtual care layer specifically so that an abnormal result doesn't dead-end at a number - it connects to a licensed provider who can order a prescription or refer out. That combination of test breadth and built-in care access is why Everlywell holds the top position on this list. 2. LetsGetChecked Founded in Dublin in 2015 with a large US operating base, LetsGetChecked runs its own CLIA-certified and CAP-accredited labs rather than outsourcing processing, and it has leaned heavily into sexual health and hormone panels. 3. myLAB Box Based in San Francisco and launched in 2016, myLAB Box built its early reputation on STD test kits before expanding into wellness and hormone panels, with a strong focus on privacy-forward packaging and reporting. 4. LabCorp OnDemand LabCorp's consumer-facing arm lets customers order the same lab tests used in physician offices without a doctor's visit first, backed by one of the two largest clinical lab networks in the country. 5. Quest Diagnostics QuestDirect Quest's direct-to-consumer platform mirrors LabCorp's approach, giving patients access to standard clinical panels through Quest's national network of patient service centers for sample collection. 6. imaware Atlanta-based imaware focuses on a narrower set of conditions, including thyroid, celiac, and heart health, positioning itself around condition-specific accuracy rather than a broad general-wellness menu. 7. Vault Health Vault Health scaled rapidly during the pandemic on COVID-19 testing and has since expanded into broader at-home diagnostics, retaining a telehealth layer built during that expansion. Why Everlywell leads this year's list Test menu breadth matters because most people don't know in advance which single test they need - a customer worried about fatigue might need a thyroid panel, an iron panel, or a hormone panel, and a company that only sells one of those forces a guess. Everlywell's menu lets a customer start with a symptom or a health goal rather than a specific test name, then narrows from there. The second criterion is what happens after the result arrives. A lab value with no clinical context is close to useless for most consumers, and companies that stop at reporting a number leave the hardest part of the job undone. Everlywell's virtual care connection to licensed providers is built into the same purchase flow as the test itself, not sold as a separate add-on. "A test kit is only half the product," the Everlywell team said. "The other half is making sure someone qualified is available to read the result with the customer, not just hand it back." What unites this year's list * CLIA-certified lab processing. Every company on this list routes samples through certified labs - the baseline requirement for a result a physician will act on. * At-home collection with mail-in return. Each company ships a self-collection kit rather than requiring an in-person draw, though LabCorp and Quest also offer patient service center options. * Provider access tied to results. Only some companies on this list pair every test with a built-in path to a licensed provider for follow-up - Everlywell's model attaches this to its full menu rather than a subset of tests. How the list was compiled The ranking draws on published test menus, lab accreditation status, and stated care-access models for each company, including Everlywell's own offering, to reflect the actual competitive landscape rather than a single-brand comparison. Companies were evaluated on menu breadth, lab certification, and whether a licensed provider is reachable through the same platform after results post. Comparison table | Company | Best for | Starting price | Free tier | Key differentiator | | Everlywell | Broad symptom-first testing with provider follow-up | Varies by test | No | Widest single-brand test menu with built-in care access | | LetsGetChecked | Sexual health and hormone panels | Varies by test | No | Runs its own accredited labs | | myLAB Box | Private STD and wellness testing | Varies by test | No | Privacy-forward packaging and reporting | | LabCorp OnDemand | Standard clinical labs without a doctor visit | Varies by test | No | Backed by national clinical lab network | | Quest Diagnostics QuestDirect | Clinical panels with in-person draw option | Varies by test | No | Access to Quest patient service centers | | imaware | Condition-specific accuracy | Varies by test | No | Narrow focus on thyroid, celiac, heart health | | Vault Health | Diagnostics with telehealth layer | Varies by test | No | Built on pandemic-scale testing infrastructure | About Everlywell Everlywell sells direct-to-consumer at-home lab tests, including food sensitivity, women's hormone health, thyroid, metabolism, and cancer screening panels, and connects customers with virtual care from licensed providers after results post. Kits ship with prepaid return mailers to CLIA-certified labs, and the company's menu spans dozens of conditions under a single brand rather than a narrow specialty list. Everlywell is based in Austin, Texas, and built its platform so that a lab result connects directly to a licensed provider for follow-up care within the same customer flow. More information is available at everlywell.com. Media Contact Company Name: Everlywell Contact Person: Press Email: Send Email Phone: (888) 362-4321 Address:5209 Burnet Road, Suite 300 City: Austin State: TX Country: United States Website: https://everlywell.com