The WISDOM Study is working to find a better way to detect and prevent breast cancer, in partnership with women of all communities. The study compares two safe and accepted approaches to breast screening and recommends risk reduction strategies so together we can improve breast health for ourselves, our sisters, our daughters, and women in the future.

By participating in the WISDOM Study, you join a community of 100,000 empowered and committed women who are helping to determine the best way to screen all women – a way that most effectively finds breast cancers and reduces harm.

Opportunity to learn about your personal risks for breast cancer.

Receive updated yearly screening plans based on changes to your risk factors and latest scientific research findings.

• Potential access to advanced genetic testing that is currently not routinely available.

• Potential access to a online educational tool to learn more about your personal risks.

• Opportunity to consult with Breast Health Specialists.

• Stay informed of the latest science and research on breast health.

• Be a part of a growing, passionate community of breast health advocates!

The WISDOM Study services are provided at no cost to you. These services include breast cancer risk assessment, genetic testing (for those in the Personalized Arm), and Breast Health Specialist consultations (when applicable).

The WISDOM Study does not order or cover the costs of your routine screening services. These may include breast imaging (mammograms, MRI scans and ultrasounds), breast procedures, or any other standard of care tests.

The WISDOM Study strongly recommends that all participants confirm with their insurance carrier all breast health-related costs that they may be responsible for paying, prior to scheduling an appointment.

Your insurance coverage and co-pays for breast imaging will not change as a result of study participation.

Once you register for the WISDOM Study you will learn about the two study groups (Annual and Personalized). You will choose your study group (Please note between the ages of 30-39 will automatically will be enrolled in personalized group; Annual group is only available to 40 and up age group). You will complete questionnaires online about your health history. If you have had a mammogram in the past, our researchers will collect and review your mammogram reports for your breast density data. Based on this information, and your study group, our study doctors will determine your screening recommendation. You will also receive information about how to prevent breast cancer and stay healthy.

An important aspect of the WISDOM Study is an ongoing review of your breast health history and current exams by our clinical team in order to detect any changes to your breast tissue. As part of the WISDOM Study, you will have a personal account for a digital tool called Mammosphere. Mammosphere enables you to electronically request your breast health records from your doctor and share those records with the study team. Simple and secure.

On the initial consent form that participants completed, participants agreed to receive screening plans for 5 years, and allow WISDOM to stay in touch and review each participant’s breast health records for 10 years.

The WISDOM consent form is available for you to review both in your WISDOM Study portal and here.

Decades of research have provided us with a better understanding of breast cancer biology and the factors that contribute to breast cancer risk. The WISDOM Study will give us the opportunity to use what we now know to find the safest and most effective breast screening program for all women. We will be looking at the following factors to determine your breast cancer risk, regardless of which study group you are in (Annual or Personalized):

• Your age

• Your race/ethnicity

• Your family history of breast cancer

• Your history of benign (non-cancer) breast procedures

Your breast density (how fibrous and glandular your breast tissue is, which can be seen on your mammogram)

If you are in the Personalized study group, these additional factors will be included in your breast cancer risk assessment:

• Your genes (inherited gene mutations that have been linked to breast cancer risk)

The WISDOM Study is looking at nine genes associated with breast cancer risk. These nine genes are:

BRCA1
BRCA2
ATM
P53
PTEN
CHEK2
CDH1
PALB2
STK11

In addition, the WISDOM Study is looking at single nucleotide polymorphisms (SNPs), which are small changes in certain genes that individually do not mean much, but together can increase or decrease a woman’s breast cancer risk. In most cases, the SNP score (called a Polygenic Risk Score, or PRS) itself will not place a woman into a higher risk category.

Color takes your privacy very seriously, and only collects the information that is necessary to return high-quality and accurate results. Color complies with the applicable privacy and security rules established by HIPAA, which is the same standard followed by hospitals and other healthcare institutions. Our compliance with HIPAA means that all personally-identifiable health information is encrypted and stored safely. Color only shares information with the test user and the ordering provider, as well as additional healthcare providers designated by the test user.

Color also does not sell any information to third parties. WISDOM participants are initially opted out of third-party research. During enrollment, WISDOM participants can access their account settings to control how Color might share their data with outside parties, such as third-party researchers.

Color does not license others to conduct research on saliva samples that are analyzed for the WISDOM Study.

Color does not sell any participant data without the participant’s specific consent. Color has not partnered with any pharmaceutical company to offer this option. If Color did offer this option in the future, Color would require participants to sign an Informed Consent, Privacy Policy and Terms of Service to assure that participants know exactly how Color would be using their data.

Color does however donate de-identified variants (gene mutations) that are found through their genetic analysis, to public variant databases, such as the National Center for Biotechnology Information’s (NCBI) Clin Var. Clin Var is a public archive where anonymous genetic information is accessible to researchers to better understand the connection between genetics and disease. WISDOM Study participants cannot opt out of this.

For more information about Color’s Privacy Policy, please visit: www.color.com/privacy-policy, or contact privacy@color.com.