HerediGene: Population Study

Post-study information

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What is HerediGene®?

The HerediGene: Population Study was opened to study the genes of hundreds of thousands of participants to better predict and prevent serious diseases. While the study is no longer taking new enrollments, our team is still processing data and gathering important findings.

Genes control everything from your height, to how you respond to certain medications, and even your risk for developing disease. The more we know about DNA, the more we can personalize healthcare at a genetic level. We want to discover new connections so we can prevent disease and improve treatment.

Intermountain Health is leading other health systems across the world in precision genomics, changing the way patients plan for their health and receive care when they need it. By studying the genetic makeup of such a large group, we have the potential to make discoveries that may allow us to predict individuals’ risk of disease and even prevent diseases from developing.

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Will I receive a report on my genetic risks?

It is predicted that a very small percentage – about 3% of the population – will receive a report identifying a known, disease-causing variant. You can choose to learn your results or refuse them. We will only report on variants we can treat and/or manage. HerediGene: Population Study results do NOT replace clinical testing.  

Most participants will NOT hear back on the findings. Negative results, in which no known or treatable disease-causing gene variants were found, will not be reported back. A negative result from HerediGene does not mean you are free from the risk of genetic conditions.

Talk to your doctor or genetic counselor if you have a family history of hereditary disease or believe you are at risk for hereditary disease.

FAQs

Find answers to the most frequently asked questions about HerediGene.

Genetic counseling can help you understand how your genetics and family history can impact your health. A genetic counselor is a healthcare professional with advanced training in medical genetics and counseling.

During a consultation with a HerediGene genetic counselor, you can expect to talk about certain medical conditions that you have had, or that run in your family. Your genetic counselor will also explain more about the genetic testing that was performed for you, including what was found, how the results might affect you and your family, and what to do next with this information.

This Study is looking at genetic changes (variants or mutations) related to an increased risk for certain cancer, heart, and other genetic conditions (such as hemochromatosis) that have medical treatments or interventions available. These genetic changes can be hereditary, meaning you inherited the genetic change from one of your parents who also carries it. If you have children, they will also have a chance of inheriting this genetic change.

HerediGene is a research program that looks at your DNA for information that may affect your health and increase risk for certain health conditions. While we may find genetic information that affects your health, results from the Study are research results that have not been confirmed using clinical testing and should NOT be used to make any diagnoses or medical decisions. 

If the Study found that you have a risk for an identified health condition, you may have the opportunity to have your research results confirmed with a clinical genetic test through the HerediGene Study at no cost to you. If the gene variant is clinically confirmed, this information will be added to your medical record and can be used in your medical care.

No - research results are not as accurate as clinical grade testing performed by CLIA approved laboratories. The Clinical Laboratory Improvement Amendments (CLIA) are a set of federal regulations established to ensure the quality and accuracy of laboratory testing performed on humans in the United States. Your research results are used for research purposes only and will not be used for your clinical care. However, if your research results identified a risk for a health condition, you can choose to schedule a phone consultation with a Study genetic counselor who can help you understand your research results and decide whether you want to provide a new sample for clinical-grade genetic testing to confirm or override the HerediGene research results. If clinical grade testing is performed, the results will be added to your medical record to help guide your clinical care moving forward.
If you choose to proceed with clinical testing offered to you through HerediGene, the confirmed clinical results will become part of your medical record at Intermountain Health. Your Intermountain Health providers will be able to see your results and use them in your care. As with all your Intermountain Health medical record information, these results are considered as Protected Health Information (PHI) and protected by our Privacy and Health Insurance Portability and Accountability Act (HIPAA) policies the same way as all your other medical record information. As such, you can also request a copy of your clinical genetic test results and you may share them with other healthcare providers, family members, or other entities if you choose to do so.
The results we are returning are for health conditions with well-known risks and screening/prevention options available. This information can help you be proactive about health risks by pursuing additional health screenings and letting your family members know about these risks so they can also be proactive about their health. Learning about your genetic risk for health conditions does not mean that you will definitely be affected by that health condition, but it provides you the opportunity to consider additional measures to help manage your risk with your health care providers.

If you have a clinically confirmed gene variant associated with a genetic condition, some of your family members could have the same gene variant. Your genetic counselor can help identify who is at risk in your family and how to share this information with them.

If your family members enrolled in HerediGene and have not been contacted about any results, they should NOT assume that they do not have any gene variants or risks for genetic conditions that may affect their health care.

Clinical grade genetic testing is the best way to know if a person is positive or negative for a specific gene variant linked to a genetic condition that affects their health. If your relatives are interested in their own genetic testing, they should make an appointment with a genetic counselor or other genetic specialist outside of HerediGene.

Yes, you can include anyone you would like in the genetic counseling consultation visit. We can add additional attendees virtually using an email address or phone number. When you invite others to participate in the phone consultation, you automatically provide the Study team permission to share your research results with them.

As always, it is your choice to participate in genetic counseling. It would still be helpful to the Study team to confirm that the research finding matches your known diagnosis. If you are willing to share this information, the Study team may request a copy of your previous results. A Study genetic counselor can help arrange that.

Many people are concerned about the potential for genetic discrimination. Ask your genetic counselor to explain the legal protections in place to address those concerns.

In the United States, we have a law called the Genetic Information Nondiscrimination Act (GINA). This federal law prohibits discrimination based on genetic information in health insurance and employment. GINA does not prohibit employers from asking for health-related information, but they must ensure that they are not requesting genetic information. GINA protections do not apply to life insurance, long-term care insurance, and disability insurance at this time. If you already have these insurances in place, they would not be affected, but if you were to change your policy or get a new policy, these insurances can ask you about your genetic information and make decisions based on that.

According to GINA, genetic information includes:

  • Your genetic test results.
  • Your relatives' genetic test results (up to and including fourth-degree relatives).
  • Information about family history of any disease or disorder. 

 Exceptions to GINA:

  • The U.S. Military is permitted to use genetic information to make employment decisions.
  • GINA does not apply to employers with fewer than 15 employees. 
 

No, there is no cost to participate. Participation costs are covered by the HerediGene: Population Study, so you and your health insurance company will not be billed for any of the research tests that are part of this Study. The genetic counseling consultations and clinical genetic testing related to research findings are also covered by this Study.

If you have a confirmed genetic variant that increases your risk for a health condition, you may need specific follow-up care (such as laboratory tests, imaging studies, or an appointment with a specialist). This type of follow-up care is treated like your other healthcare and would be billed to you and/or your health insurance company, as it would be care that is no longer part of the Study.

Yes. You can choose to withdraw from this Study at any time. You must submit this notice in writing to:

Dr. Stacey Knight 
Intermountain Health 
5121 S. Cottonwood St. Building 1 Level 4 
Murray, UT 84107 

If you decide to leave the HerediGene: Population Study, the data we have already collected will remain in the Study database. New information will not be collected. Blood and data sent to our research partners will remain with those entities for continued research purposes. Blood samples at Intermountain Health that have not yet been analyzed will be destroyed.

Who is Intermountain Health collaborating with on HerediGene: Population Study?

This Study represents a joint-access data collaboration between Intermountain Health, Culmination Bio, deCODE Genetics, and Amgen. Culmination Bio collaborates with Intermountain Health, forming partnerships to power insights for medical research, health data, and healthcare services. deCODE Genetics is a genetic testing and research company located in Reykjavik, Iceland. Amgen is a biotechnology company that discovers and develops human therapeutic drugs. All samples and clinical data are de-identified before being sent to research partners outside of Intermountain Health.