Informed Consent for Genetic Testing (“Informed Consent”)

New Terms Updated January 16, 2025

This document reviews the benefits, risks, and limitations of genetic testing. It also explains how samples and information provided for or derived from genetic testing will be used, protected, and disclosed. This informed consent applies to any and all genetic tests performed at Color. 

What does the test include?

A list and description of all of Color’s tests can be found at https://www.color.com/genes. The Tests applicable to me are listed in my account. Some tests also can include non-clinical traits and genetic ancestry information.

You are not required to have genetic testing. Your participation is completely voluntary. However, in order for testing to be performed you must confirm that you have read, understood, and agree to this Informed Consent. 

• Note: throughout this document “you”, “your”, “I”, or “my” refers to the person whose sample is being tested. 
• If you have any questions before agreeing to this Informed Consent, you can speak to a healthcare provider or genetic counselor by reaching out to us at (844) 352-6567. 

How does genetic testing work?

You will be asked to provide information about yourself and your family, such as your age, biological sex, and race/ethnicity; your personal history of certain health conditions, your family’s history of those conditions, and any known genetic variants in you or your family members.

A healthcare provider will review that information. If they determine that genetic testing is appropriate, they will order it for you. 

Genetic testing is performed on a small sample of your saliva or blood that is collected and is sent to Color. DNA will be extracted from the sample and sequenced. Sequenced data includes information about genes and regions relevant to the ordered genetic test(s) as well as other regions up to and including the entire genome. The results are interpreted and then made available to you through your online account and to your ordering physician. Genetic counseling will be available if you have any questions. 

What might I learn from genetic testing?

Details about the genes, variants, and alleles on the ordered test(s) can be found at www.color.com/learn/color-genes.

The results of hereditary disease genetic testing could be:

• Positive. A positive result indicates an increased risk of developing a specific hereditary disease. Knowing this may help you and your healthcare provider make more informed healthcare decisions to prevent or detect hereditary diseases at an earlier and potentially more treatable stage. A positive result may also have implications for risk of disease in your family members.
• Negative. A negative result indicates that no significant hereditary risk factors were identified. A negative result does not eliminate the risk of developing a genetic disease.

The results of pharmacogenomic testing may indicate how your body processes certain medications. Knowing this may help your provider make more informed healthcare decisions about the medications they may prescribe to you and at what dose you should take them.

What are the risks and limitations of genetic testing?

Genetic testing may or may not help you and your healthcare provider better to understand your health and health management. Genetics is only one of the factors that determine health, disease, and medication response. 

As with all genetic tests, this test has technical limitations that may yield an inaccurate or incomplete result. Some important DNA variants can be missed, either because of the way the test was designed, because of how the sample was collected or handled, or because of interfering physiological considerations (for example, a blood cancer, an organ transplant, or a recent blood transfusion). 

It is possible that Color may also identify something significant that is unrelated to the intended use of the test; Color may include this in the test report. You may discover sensitive or unexpected information about family relationships or potential health or disease risks in close biological family members.

It is your responsibility to consider the possible impact of test results as they relate to insurance rates, obtaining disability or life insurance and employment. In the United States, the Genetic Information Nondiscrimination Act provides some protections against genetic discrimination in health insurance and employment. There are currently no U.S. federal laws that prohibit discrimination in life insurance, disability insurance or long-term care insurance.

Could my results ever change?

Medical and scientific knowledge improves over time, and new information may become available that could change the interpretation of your results. Color may notify you of updates to your results.

How does Color protect my data?

Robust technical, administrative and physical safeguards are in place to help keep your data safe and secure and to limit the use of your data only to permitted purposes and to protect it against misuse, loss, or alteration. Steps are also taken to de-identify or anonymize your data in accordance with applicable laws. Details about Color’s policies governing patient privacy and health information, including patient rights regarding such information, may be found in Color’s Terms of Service (www.color.com/policies/tos), HIPAA Notice of Privacy Practices (www.color.com/policies/notice-of-privacy-practices), and Privacy Notice (www.color.com/policies/privacy). Color complies with the applicable federal and state laws, including but not limited to HIPAA.

How does Color use my information and sample?

The Color laboratory uses the information and sample to perform the tests. The Color laboratory is a CLIA accredited, CAP approved, HIPAA-covered genetic testing laboratory. The Color laboratory receives your sample (e.g. blood, saliva) and the relevant health information, then analyzes the genetic information contained within the sample and delivers genetic test reports. 

The sample and the health and genetic information received and generated about you is considered sensitive personal data. This data is subject to strict legal requirements regarding how it can and cannot be used and how it must be protected. 

The test results are shared with the ordering physician and with Color Health genetic counselors for the purpose of providing you with access to those services.

Color also uses the information to perform related operational activities such as variant confirmation, regulatory compliance, general administrative activities, or billing and submitting claims for services and tests provided. Our contracted business associates who have entered into an agreement to maintain the confidentiality of your health information pursuant to HIPAA (Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191) may be involved in helping us with the use stated in this Informed Consent. 

Additionally, data and samples may be used for Color’s laboratory validation and quality improvement projects. De-identified results may be included in group or aggregate analyses. 

How does Color use my information and sample for research?

Color may use non-identifiable data for research purposes, such as internal activities, generating new knowledge or developing new tests, independently or in collaboration with a third party partner. I also understand I may be contacted for research opportunities and to provide feedback about products and services. If I do not wish for my non-identifiable data to be shared for research purposes, I can contact Color. I understand that my data cannot be unshared after it is shared. 

How long does Color keep my sample?

Samples will be maintained in accordance with applicable State laws but no longer than 60 days after the sample is taken, after which it will be destroyed unless you opt in to research. 

How long does Color keep my results?

Your results will be maintained pursuant to applicable health care laws, including HIPAA. 

What is retained after genetic testing is complete?

If you provide your consent via this form, and to the extent permitted hereunder, Color may store your de-identified data and samples indefinitely and use them for internal research purposes to generate new knowledge. If you do not provide express consent via this form, Color may retain samples as permitted or required under applicable law or regulation after which point they will be destroyed.

How may my data or results be shared?

Your results will be shared with the ordering provider. If your ordering provider is part of a clinic or health system, your results and information may also be made available or distributed throughout that system as part of their own treatment, payment, and healthcare operations. 

Clinical results and genetic testing information are HIPAA protected and confidential, and will only be shared further with your permission and in accordance with applicable laws. If you wish, Color can help you share your results with your family members, your doctors, or any research studies you participate in. More information about Color’s data use practices is at https://www.color.com/policies/privacy.

You may revoke this Informed Consent by contacting Color and we will honor it within 30 days. 

This completed form will be saved and accessible to you in your Color account.