Frequently Asked Questions

Find answers to frequently asked questions about the Tapestry DNA Sequencing Research Study, including information on:

• General information and participation
• Helix
• Results
• Data privacy, insurance and discrimination
• The Tapestry Genomic Registry
• Technical requirements

General information and participation

What is the purpose of the Tapestry study?

Tapestry researchers are trying to understand the impact on people's health care when genetic testing results are available in their medical records for their health care providers to see. Medical records are now called electronic health records.

Mayo Clinic is also gathering information about the genes of people in Tapestry to create a library of genetic information — also called a registry — to use for future research.

What does Tapestry test for?

The Tapestry study tests to see if you have any gene changes related to health conditions that can be passed down (inherited) from your family. You will learn if you are at risk of familial hypercholesterolemia (FH), hereditary breast and ovarian cancer (HBOC) syndrome, or Lynch syndrome.

These conditions may affect both men and women. Familial hypercholesterolemia causes high cholesterol and a higher risk of heart disease or heart attack at an early age. Lynch syndrome is tied to a higher risk of colon and uterine cancers along with other cancers. HBOC syndrome is tied to a higher risk of breast and ovarian cancers in women and breast and prostate cancers in men.

To learn more about these conditions, you can:

• Visit Mayo Clinic's webpage about FH
• Download a PDF from Mayo Clinic about hereditary breast and ovarian cancers
• Visit Mayo Clinic's webpage about Lynch syndrome

You also may choose to receive results for your family background, also called ancestry, and qualities that could have been passed down through your genes, also known as genetic traits.

How many people are participating in Tapestry?

The Tapestry DNA Sequencing Research Study team plans to enroll approximately 100,000 participants from Mayo Clinic.

Who can participate in this study?

A list of who can and cannot volunteer for the Tapestry study is posted on the Participation page.

Why wouldn't I be able to join this study?

A list of reasons people cannot volunteer for the Tapestry study is posted on the Participation page.

Why did I receive an invitation to enroll in the Tapestry study?

One of the goals of the Tapestry study is to create a large and diverse library, also called a registry, of information about many people's genes. To achieve this, the study team needs to recruit participants from different areas of Mayo Clinic who have had many different medical events in their lives. The team is looking for people with diverse medical histories.

Medical departments at Mayo Clinic identify patients who might be a good fit for the study and might want to join. The Tapestry study team sends invitations to these patients via an automated system. Those contacted might have scheduled upcoming appointments at Mayo Clinic or be receiving care now. Or they may have had appointments at Mayo Clinic in the past.

Can I participate if I have had genetic testing in the past?

You are welcome to participate in the Tapestry study whether or not you've had genetic testing before.

If you have had genetic testing before, and it told you that you have a genetic condition or specific gene changes, there is a chance that the genetic testing from Tapestry will give you different results. This is because the study uses a screening test. This is a more basic kind of test to find out who is or is not at risk of specific diseases. Other testing services or studies may use other types of tests, which could give different results.

If you have a personal or family history of disease, you should speak with your health care provider. Genetic testing through the Tapestry study is considered a screening test. It is not meant to replace in-depth clinical genetic testing recommended by a care provider.

Can I participate if someone in my family has a condition that the Tapestry study tests for?

You are welcome to participate in the Tapestry study whether or not anyone in your family has had genetic testing before. However, if you or your family has one of the conditions tested for in the study, Tapestry is not meant to replace in-depth genetic testing, such as the kind your health care provider might recommend.

If a family member has had a genetic testing result showing one of these conditions, or any other genetic condition, you should speak with your health care provider. Even if your Tapestry study results say you don't have any of these conditions, that does not rule out the possibility that a more in-depth test could give different results.

Can I participate if my primary care provider is not at Mayo Clinic?

Yes. As long as you meet the eligibility criteria, you are eligible to participate, even if your primary care provider is outside Mayo Clinic.

Can I choose to stop participating in this study?

You can choose to leave the Tapestry study at any time. Please contact the study team at tapestry@mayo.edu if you want to stop participating.

Who is funding the Tapestry study?

Funding is provided by the Mayo Clinic Center for Individualized Medicine.

Does it cost anything to participate in the study?

There is no cost for any part of this research study. However, you or your insurance provider will need to pay for all other tests and procedures that are part of your care outside of the study, including copayments and deductibles.

The Tapestry study team generally recommends more testing for less than 1% of participants. This testing needs to be done outside of Helix to confirm whether the first results were correct. You, your insurance provider or both would need to pay for the extra tests. If the Tapestry test results show that you need additional medical care, you or your insurance provider would need to pay for that too.

How do I find my Mayo Clinic number?

You can find your Mayo Clinic number on letters from your health care provider, appointment reminder letters and billing statements. You also can call Mayo Clinic Registration at 507-284-2111 (option #0) between 7:00 a.m. and 6:00 p.m. Central time, Monday through Friday. If you use Mayo Clinic Patient Online Services, the Mayo Clinic patient portal, you can find your Mayo Clinic number in your profile information.

Who should I contact if I did not receive my spit collection kit?

The study team will ship you a kit to collect your spit, also called saliva, as soon as possible — often within 1 to 2 days after you have signed the consent form. Please contact the study team at tapestry@mayo.edu if you did not receive your saliva collection kit.

If multiple people in the same household are participating in Tapestry at the same time, the team will send only one saliva collection kit at a time. The team sends a second kit after receiving the first kit back. This process is to assure that the returned collection kit is for the correct individual.

Can any Mayo Clinic patient volunteer to join the Tapestry study?

At this time, Tapestry is only open to Mayo Clinic patients who have been invited to sign up and meet certain qualifications, which are listed on the Participation page. If you are a Mayo Clinic patient and want to learn more about how to be invited, you can contact the study team at tapestry@mayo.edu. The study team will make the final decision about who to invite based on whether you are eligible and whether there is space in the study.

Helix

What is Helix?

Helix is a large-scale genetic testing and technology company that Mayo Clinic is working with to read (sequence) participants' DNA and safely store the genetic information. Learn more on the Helix website.

What is the relationship between Mayo Clinic and Helix?

The Mayo Clinic Center for Individualized Medicine is working with Helix and owns a small part of Helix.

Does Helix conduct other research?

Yes. Helix conducts independent research and works with other researchers and institutions outside of Mayo Clinic.

What is the difference between the Tapestry study and the Helix DNA Discovery Project?

Tapestry is a research study led by Mayo Clinic. The Helix DNA Discovery Project is a separate research study led by Helix.

Do I have to take part in the Helix DNA Discovery Project to take part in the Mayo Clinic Tapestry study?

No. These are separate studies that are not related to each other. If you choose to participate in the Helix DNA Discovery Project, you will need to sign a form to allow Helix to access and use your genetic information for research.

When setting up my Helix account, can I use the same email address as another user (for example, my spouse or family member)?

No. To set up a Helix account, you need to have your own email address that is not being used by any other Helix users.

If I close my Helix account, does that mean I'm no longer part of the Tapestry study?

No. If you close your Helix account, you will still be part of the Tapestry study. However, you will no longer be able to see your genetic results through your Helix account.

If I decide to withdraw from the Tapestry study, does that mean I will lose my Helix account?

No. If you leave the Tapestry study, you will still be able to use your Helix account and see your genetic testing results.

How do I withdraw from the Tapestry study?

You have the right to leave the Tapestry study and genetic library at any time. If your genetic information has already been shared with researchers, it might be hard to withdraw your information from that specific study. But your data can be withdrawn from future research. Read the "Data privacy, insurance and discrimination" section below for more information.

You can leave the study by emailing tapestry@mayo.edu.

How do I sign up to receive traits and ancestry results from Helix?

When registering your kit with Helix, you will come across an "Authorization for Release of My Information to Helix" option that you will be asked to accept or decline. If you accept, you will receive Helix Ancestry and Helix Trait results. If you decline, you will not receive them.

Your ancestry and traits results are not part of the Tapestry study and will not be stored by Mayo Clinic for future research. If you have questions about the Helix Ancestry or Helix Traits reports, please reach out to Helix customer support directly by phone or email.

Helix Customer Support

Phone: 844-211-2070, Monday-Friday, 8:00 a.m.-5:00 p.m. Pacific Standard Time

Email: support@helix.com

Results from Tapestry

What data or results will I receive?

Your results will include screening information to tell if you are at risk of several health conditions. You will learn if you are at risk of familial hypercholesterolemia (FH), hereditary breast and ovarian cancer (HBOC) syndrome, or Lynch syndrome.

These conditions may affect both men and women. FH causes high cholesterol and higher risk of heart disease or heart attack at an early age. Lynch syndrome is tied to higher risk of colon and uterine cancer along with other cancers. HBOC syndrome is tied to higher risk of breast and ovarian cancers in women and breast and prostate cancers in men.

To learn more about these conditions, you can:

• Visit Mayo Clinic's webpage about FH
• Download a PDF from Mayo Clinic about hereditary breast and ovarian cancers
• Visit Mayo Clinic's webpage about Lynch syndrome

You also may choose to receive results for your family background, also called ancestry, and qualities that could have been passed down through your genes, also known as genetic traits.

How long does it take to receive results?

Each participant's results are unique, so the Tapestry team can't give you an exact time for when you will receive your results.

There are two major steps in the process. First is sequencing your DNA, which allows researchers to read the results and could take 4 to 12 weeks. When this step is complete, your Helix Ancestry and Helix Traits results will be available to view through your Helix account, if you chose to get them when registering your kit.

In the second step, your health report — which screens for gene changes related to familial hypercholesterolemia (FH), hereditary breast and ovarian cancer (HBOC) syndrome and Lynch syndrome — is sent to a medical team for interpretation. This step can take another 4 to 8 weeks.

Once your results are available in the Helix portal, you will receive an email notification from Helix.

Why do I need to sign a form to get information about my ancestry and genetic traits?

Helix Ancestry and Helix Traits are Helix products and not part of the Tapestry study. Helix Ancestry tells you about your family background. Helix Traits tells you about qualities that could have been passed down through your genes. If you would like to receive these products, you need to sign a specific form for this. The form allows Helix to access and use your genetic information to provide you with these products.

Will my genetic testing results from Tapestry be entered into my electronic health record at Mayo Clinic?

Yes. The Tapestry team will enter information into your electronic health record about your screening results for each of the three conditions the study tests for: familial hypercholesterolemia (FH), hereditary breast and ovarian cancer (HBOC) syndrome, and Lynch syndrome.

Whether Tapestry shows that you have positive results or negative results, the information will be entered into your electronic health record. A positive result means you have a gene change related to one of the conditions that Tapestry tests for. A negative result means you don't have gene changes for the conditions. If you do not want the results of the genetic testing to be part of your electronic health record, you should not take part in this study.

Results about your family background or qualities that could have been passed down through your genes will not be entered into your electronic health record.

What happens if my test result is positive?

A positive result means you have a gene change related to one of the conditions that Tapestry tests for. If you have a positive result, the Tapestry study team will try to contact you by email, phone or certified letter to discuss next steps.

Mayo Clinic will offer you free genetic counseling to discuss your results and any recommendations for changes to your current health care routine.

The Tapestry genetic counselor will also notify your Mayo Clinic primary care provider if your test result is positive. Your results will be entered into your electronic health record.

What happens if my test result is negative?

A negative result means you don't have any gene changes related to the conditions that Tapestry tests for. Any negative result significantly reduces the chance that you are at risk of developing one of the conditions. But it does not completely eliminate the risk. You should talk to your care provider about your results, especially if there is a family history of any of these conditions.

Please note that the genetic testing done through Tapestry does not replace genetic testing you may have as part of your regular care from your health care provider and health care team. The genetic testing performed as part of Tapestry is generally not as complete as testing that your care provider might recommend for a specific concern based on symptoms or family history.

Your Tapestry results will be entered into your electronic health record. If you do not want your results to be part of your electronic health record, you should not take part in this study.

What happens if I already know I have one of the conditions included in the Tapestry study results?

All Tapestry participants are offered the same screening test through Helix, no matter what the past genetic testing results were. If a previous genetic testing result was positive for one of the conditions that Tapestry tests, you will probably get the same result from the Tapestry test. The Tapestry study team can compare your Tapestry result with your past genetic testing results to make sure it is the same gene change.

But even if you've gotten a positive result in the past, it's possible to get a negative result from the Tapestry test for the same conditions. There is also a chance that the Tapestry test may not identify a gene change identified by other genetic testing. Certain gene changes are outside the range of what Tapestry's screening test can analyze. A disease-specific test that your health care provider recommended in the past may have provided a better view of certain parts of your DNA than Tapestry's screening test.

If you receive an unexpected negative test result, please contact the Tapestry study first so that the study team can help determine the reason for the result.

Will my test results be available through Mayo Clinic Patient Online Services, Mayo Clinic's patient portal?

No. The Mayo Clinic patient portal is not able to show your test results from the Tapestry study. When your results are available, you can view them by logging into your Helix account.

What happens if future research using my genetic information finds new results that may affect my health?

A study team may contact you in the future and give you the option to learn these results. It could be the Tapestry team or another team doing different research. Please read the "Data privacy, insurance and discrimination" section below for more information about who might use your genetic information and how it's protected.

Every research team that could possibly use your genetic information in a study, including in the future, will have to create a plan that includes how to handle new results. The Institutional Review Board at Mayo Clinic makes sure that every research study has a plan to protect you and your information, and that study teams now and in the future follow the plans they create.

Should I share my results with my family?

Your results could be important information for the health of your blood relatives, such as parents, siblings, aunts and uncles, grandparents, or cousins. This is true whether or not your results say you have a gene change related to one of the conditions that Tapestry tests for. Speaking with a genetic counselor will help you understand what the impact may be and decide whether you would like to share the results with your blood relatives.

How do I share my results with my primary care provider who is not at Mayo Clinic?

To allow us to share a copy of the Helix report with your primary care provider outside Mayo Clinic, you'll need to complete a Mayo Clinic release of information form. You can initiate this step by contacting Health Information Management Services at Mayo Clinic's campuses in Arizona, Florida or Minnesota.

The Helix report shows my gender assignment at birth. Can this be changed?

Unfortunately, this cannot be changed. Helix tests genes on multiple chromosomes, including on the X and Y chromosomes. The report needs to indicate your gender at birth because this information affects how Helix makes sure the test is accurate, finds information about your genes and makes sense of the results.

Why do my Helix ancestry results differ from results I've received from other laboratories?

Ancestry testing is an estimate of someone's ethnic background, but it is not a perfect science nor is it a medical test. Companies look at genetic markers that are common in various populations. They estimate ancestry based on how many markers a person has. Each company uses different methods and different numbers of markers to make this determination, which means that they may get different results.

Data privacy, insurance and discrimination

Who will have access to my genetic data as part of this study?

Both Mayo Clinic and Helix will have access to your genetic data. Some of your Tapestry results will be entered into your Mayo Clinic electronic health record.

Are there laws that protect the privacy of research participants?

Mayo Clinic adheres to federal privacy laws. The Tapestry study is overseen by an institutional review board as governed by the National Institutes of Health human participants' research protections.

Will my genetic data be used for other research at Mayo Clinic?

Yes. Tapestry is a resource meant to serve the research community at Mayo Clinic — and at other institutions — now and in the future. Your participation will help researchers study the roots of disease and work to find new treatments for many years to come.

Mayo Clinic researchers who aren't involved with Tapestry may ask to use information or samples from the library for future research. These researchers may receive identifiable information — such as your name, address, phone number or email — to help with their research.

Helix researchers and people from other organizations might ask to use the library as well. These include people from for-profit companies or people doing research to make a profit.

Anyone who wants to use information from the Tapestry library must ask permission from Mayo Clinic first. Mayo may send the information or samples to researchers who request them. Mayo will not send your name, address, phone number, email or any other identifying information. Instead, your information or samples would have a code, and only the Tapestry study team at Mayo Clinic would be able to link the code to you.

Can I request that my genetic information not be used by either Mayo Clinic or Helix?

Yes. You can request that the Tapestry study team stop using your information by emailing tapestry@mayo.edu.

You also can choose to end your relationship with Helix at any time, including asking Helix to delete your information, by contacting Helix customer support at support@helix.com.

Will my genetic information be available to the public?

No. Neither Mayo Clinic nor Helix will make your genetic information public.

However, it is helpful for researchers to share data they get from studying samples and information. They do this by putting it into scientific databases. Researchers can study the shared data to learn even more about health and disease.

If you agree to take part in the Tapestry study, some of your genetic and health information may be placed into one or more scientific databases. Your name or other information that could identify you, such as your address or phone number, will never be placed into a scientific database.

How will Helix use any of my remaining DNA after the test is complete?

Helix researchers may use your DNA to double-check the quality of their own lab tests and procedures, but your name and other information that could identify you will be removed. Read about Helix's privacy policy on the Helix website.

How is my genetic data protected?

Both Mayo Clinic and Helix have expert teams that focus on protecting sensitive information about people's health, converting it into code so that others can't read it, and storing it safely.

Will my health insurance company have access to my results?

Health insurance companies can see genetic testing results in your medical record in the same way they can see other medical information about you. This means that health insurance companies might be able to see your results if the results are entered into your electronic health record. However, under the Genetic Information Nondiscrimination Act (GINA), most health insurance companies are not allowed to use genetic information to make decisions about whether to cover individuals or cost of coverage. More information is available on the GINA website.

Will Mayo Clinic or Helix share my genetic information with anyone else?

Mayo Clinic and Helix will only share your genetic information or other identifiable information — such as your name, phone number, address or email — if you sign a form giving your permission.

Mayo Clinic researchers who aren't involved with Tapestry may ask to use information or samples from the library for future research. These researchers may receive identifiable information — such as your name, address, phone number or email — to help with their research.

Helix researchers and people from other organizations might ask to use the library as well, including people from for-profit companies or people doing research to make a profit.

Anyone who wants to use information from the Tapestry library must ask permission from Mayo Clinic first. Mayo may send the information or samples to researchers who request them. Mayo will not send your name, address, phone number, email or any other identifying information. Instead, your information or samples would have a code, and only the Tapestry study team at Mayo Clinic would be able to link the code to you.

What is the Genetic Information Nondiscrimination Act (GINA)?

GINA is a federal law that protects most people from genetic information discrimination by health insurance companies and employers. GINA does not protect people from discrimination regarding certain other types of insurance, such as life insurance, long-term care insurance or disability insurance. For these types of insurance, insurance companies can use genetic information to make decisions about individual coverage and cost of coverage. More information is available on the GINA website.

Will my genetic test results impact my children's insurance?

If you test positive, your children or other blood relatives also may decide to get tested to see if they are at higher risk of getting the disease. Their genetic test results would be protected by GINA.

GINA is a federal law that protects most people from genetic information discrimination by health insurance companies and employers. This includes family history genetic information. GINA does not protect from discrimination related to certain other types of insurance policies, as described above. Companies offering these types of insurance may inquire about family history of disease as part of their enrollment process. More information is available on the GINA website.

Tapestry Genomic Registry

What is the purpose of a genomic registry?

A registry is a library of information, biological samples or both. The Tapestry registry contains genetic information from everyone in the Tapestry study. It is meant to support future research for many years. By storing the genetic information of many people in one registry, researchers save time because they can skip the step of finding new participants for each new project.

What are the benefits of having my genetic data in a registry?

The purpose is to benefit future generations by supporting new research. A registry is not meant to provide you with personal health benefits or other direct benefits.

Who can use the Tapestry Genomic Registry?

Researchers from Mayo Clinic, researchers outside Mayo Clinic, and people from industry or private companies may ask to use information from the registry for new studies or commercial projects. Mayo Clinic has strict policies and procedures in place to protect data privacy and to decide who can use the registry and how.

Could Mayo Clinic or others use data in the registry to make money?

Yes. Some examples of how the genomic registry could be used to make money include:

• Charging a fee to researchers or private companies to cover the costs of sharing the data in the registry. One example is the cost of sending digital genetic information securely.
• Developing future agreements with outside groups or institutions to pay to use genetic information from the registry.
• Using information from the registry to discover new medications, medical tests or other medical advances. This may result in Mayo Clinic or other groups profiting from these discoveries.

What happens to my samples and information when I die?

Once you die, your genetic information will be considered a gift to Mayo Clinic. That means Mayo Clinic can continue using it in the ways described in the consent form forever, even if your family wishes that you had not donated a sample.

Since this study involves your genetic information, your family may want access to it after you die. On the consent form, you can choose whether you would like to choose someone to receive information from the study team about genetic results that may impact health.

Can I withdraw from the Tapestry Genomic Registry?

Yes. You have the right to have your information removed from the Tapestry Genomic Registry at any time. If your genetic information has already been shared with researchers, it might be hard to remove your information from that specific study. But your data can be withdrawn from future research.

You can request to stop having your data used by emailing tapestry@mayo.edu.

Technical requirements

Do I need to use a specific internet browser to access the Helix platform and access my results?

The minimum versions of supported browsers are as follows:

Supported browsers	Minimum version
Chrome	60
Edge	15
Firefox	60
Safari	10.1
Safari (mobile)	10.3
Samsung Internet	7
Internet Explorer (IE)	Not supported