Question 1

Who is eligible for the Clairity Breast Cancer 5-Year Risk Assessment?

Accepted Answer

Clairity Breast is intended for any adult who has undergone a screening mammogram. Clairity Breast isn't for everyone. It excludes anyone under 18, anyone with a current diagnosis of breast cancer ("current" meaning the patient has not completed primary first-line therapy which includes surgery and/or radiation), and anyone with a known high-penetrance inherited breast cancer gene mutation, such as BRCA1 or BRCA2. If any of this applies to you, talk with your provider about the right screening and risk-assessment plan for you.

Question 2

What kinds of results will I receive from the Clairity Breast Cancer 5-Year Risk Assessment?

Accepted Answer

Clairity Breast provides a prediction of the percentage probability that the individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram, through analysis of mammography features and characteristics.

Question 3

How accurate is the Clairity Breast Cancer 5-Year Risk Assessment?

Accepted Answer

Clairity Breast was tested on more than 250,000 mammograms in women across the US and Europe and is the first FDA authorized AI-driven software to assess breast cancer risk in women with a screening mammogram.¹ ² ³ You should review your result with your provider, rather than interpreting it alone, so they can consider this risk score and your full health profile to determine any additional screening steps that may be right for you. Clairity Breast scores greater than 5% should be interpreted with caution. While all scores greater than 5% are considered high risk, high risk scores produced by the model may tend to significantly overestimate risk, particularly scores above 10%. Full Clairity Breast disclosures are available here.

Question 4

What does my Clairity Breast risk result mean?

Accepted Answer

You will receive your Clairity Breast risk score along with recommendations aligned with the screening and risk reduction guidelines from the National Comprehensive Cancer Network (NCCN). Your result will fall into one of three risk categories: An average-risk result means Clairity Breast estimated your 5-year risk of breast cancer to be less than 1.7%. Customers with average-risk results are advised to continue regular yearly mammograms and to discuss the result and their full history with their provider so they can determine whether any additional screening steps should be considered. Additionally, we advise repeating the Clairity Breast Risk Assessment each year as part of a screening and risk reduction plan. An intermediate-risk result means Clairity Breast estimated your 5-year risk of breast cancer to be between 1.7% and 2.9%. Customers with intermediate-risk results are advised to discuss the result and their full history with their provider to confirm their screening plan and risk reduction options. Annual breast MRI with and without contrast is recommended for consideration in women at this risk level. Additionally, the screening plan should include continuing yearly mammograms and regular breast health visits. Additionally, we advise repeating Clairity Breast Risk Assessment each year as part of a screening and risk reduction plan. A high-risk result means Clairity Breast estimated your 5-year risk of breast cancer to be 3% or higher. Customers with high-risk results are advised to discuss the result and their full history with their provider to confirm their screening plan and risk reduction options. Annual breast MRI with and without contrast is recommended for consideration in women at this risk level. The screening plan should also include continuing yearly mammograms and regular breast health visits. Additionally, we advise repeating Clairity Breast Risk Assessment each year as part of a screening and risk reduction plan.

Question 5

Can Clairity Breast diagnose breast cancer or replace my mammogram report?

Accepted Answer

No. Clairity Breast does not detect or diagnose breast cancer and does not replace radiologist interpretation of the screening mammogram.

Question 6

What does the Clairity Breast Cancer 5-Year Risk Assessment analyze?

Accepted Answer

Clairity Breast is the first FDA-authorized, AI-driven software that analyzes patterns in your existing screening mammogram, the same image your provider already reviewed for signs of cancer today, to estimate your 5-year breast cancer risk.

Question 7

Does Clairity Breast replace genetic testing or family-history-based risk assessment?

Accepted Answer

No. The AI image-only models are not intended to replace genetic or clinical risk assessment approaches. They are meant to complement other established methods for risk assessment.

Question 8

What happens after purchase?

Accepted Answer

After you purchase, you'll complete the intake with details about your last mammogram and imaging facility and sign a medical records release form -- this lets Clairity request your mammogram images on your behalf, so you don't need to upload anything yourself. If you don't already have an eligible mammogram, we'll help you find a compatible imaging location. If your images can't be retrieved or aren't eligible for analysis, you'll receive a full refund. Once your images are in, your results are reviewed and shared in your MyEverly results portal along with next-step guidance to discuss with your provider.

Question 9

What imaging systems are compatible with Clairity Breast?

Accepted Answer

Clairity Breast analyzes full-field digital mammograms or directly acquired 2D images from Hologic Lorad Selenia® and Selenia® Dimensions® Mammography Systems. It is not compatible with synthetic 2D (s-2D) or digital breast tomosynthesis (DBT) images. Mammography centers can be found on the U.S. Food and Drug Administration (FDA) Mammography Facilities page. When booking, ask the facility to confirm your screening mammogram will include standard 2D images on a Hologic Selenia or Selenia Dimensions system.

Question 10

Will I need to repeat the Clairity Breast test in the future?

Accepted Answer

Each new screening mammogram can generate a new risk score. We recommend repeating the assessment with each new screening mammogram you get.

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