Everlywell Expanded Access to Cancer Risk Tool

The Clairity Breast artificial intelligence risk assessment tool is now available to women nationwide.

Updated on Oct. 1, 2026 in Cancer

Everlywell Expanded Access to Cancer Risk Tool

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Everlywell has launched national access to the Clairity Breast A.I. tool, which analyzes mammogram images to estimate a five-year risk of developing breast cancer. The assessment is available to individuals who have received a standard mammogram within the past 12 months.

Why it matters

The technology aims to help identify sporadic breast cancer risks to improve early detection rates. Proponents believe the availability of this assessment could encourage more women to prioritize mammograms at younger ages.

The test costs $249 and provides risk scores based on mammograms taken within the last 12 months. Results categorize risk as average for scores below 1.7 percent, intermediate between 1.7 and 3 percent, and high at 3 percent or above.

The players

Everlywell

Everlywell is a digital health company that provides at-home testing kits and telehealth services for a variety of health conditions.

Food and Drug Administration

The Food and Drug Administration is the federal agency responsible for protecting public health by regulating medical devices and diagnostic tools.

The details

Everlywell retrieves a patient's mammogram image from their medical provider to feed the data into the Clairity platform, which identifies imaging patterns correlated with future cancer development. The test is not a diagnostic tool for current cancer and is not intended for women with known genetic mutations or those currently undergoing cancer treatment.

The FDA approved the Clairity Breast tool in 2025.
The assessment requires a mammogram result from within the past 12 months.
Everlywell expanded national access to the tool on October 1, 2026.

The Big Picture

This launch follows the established regulatory framework of the FDA's 510(k) clearance process for software as a medical device. The integration of such diagnostic A.I. into consumer-facing platforms marks an evolution in how patients interact with medical imaging data.

Women seeking the test must pay the $249 out-of-pocket, as insurance does not currently cover the assessment. Users should consult their healthcare provider to discuss how these risk scores impact their personal screening schedule.

The takeaway

This tool provides an additional data point for patients to discuss with their doctors during annual wellness visits. It is important to remember that this test calculates future risk and does not serve as a diagnostic screen for current cancer.