Genetic Testing FAQ

Nevada residents over the age of 18 years with an active Renown MyChart account who do not have a history of a stem cell or bone marrow transplant from a donor. Renown patients who reside just outside of Nevada but seek care at Renown Health are also eligible to participate.

Our study offers screening and clinical results for three inherited genetic conditions:

• Hereditary Breast and Ovarian Cancer Syndrome
• Lynch Syndrome
• Familial Hypercholesterolemia

There is no cost to you as a participant and the results from the genetic screening will be returned directly to you and may also be made a part of your medical record. These results may indicate you are at increased risk for certain conditions, such as heart disease or certain cancers, that when detected early can have a positive impact on your health. You may also receive insights into your personal ancestry and other non-medical traits such caffeine sensitivity, earwax type and more, that may be of interest to you by signing up for an optional account with Helix.

1. Familial Hypercholesterolemia (FH): Increased risk for early heart disease and high cholesterol
2. Breast & Ovarian Cancer Syndrome (BRCA 1&2 genes): Increased risk for Breast, Ovarian, Prostate, and Pancreatic cancers
3. Lynch Syndrome: Increased risk for colon and endometrial cancers

Why only these three conditions?

A:These three conditions are CDC (Centers for Disease Control) Tier 1 clinically actionable conditions. This means that actions can be taken to treat, prevent, delay or reduce symptoms of these health conditions. Therefore, if you learn that you or your family member have an increased risk of developing any of these conditions, you and your primary care provider can follow an action plan that may help improve health outcomes.

The Healthy Nevada Project may expand to report on additional hereditary risks in the future. You will not receive additional results without your consent. We will let you know if other results may be offered in the future.

Sequencing and return of results may take up to 12 weeks once your sample has been received at the Helix lab. Helix will notify you by email with updates regarding the status of your sample and when your results are ready to be viewed on your Helix account. Your genetic results will also be populated to your medical record and viewable through MyChart.

You do not need to figure out your results alone. Although rare, if a genetic variant that is currently understood to cause an increased risk for the condition is found in your DNA, you will be contacted by phone to discuss your results and be provided with additional resources about your findings. All participants found to have a clinical finding for any of the conditions tested are offered a no cost genetic counseling session with a licensed genetic counselor. These specialists can help you navigate your results and recommend the appropriate follow up care. It is important to also follow up with your primary care provider or other healthcare professionals regarding your results. Your primary care provider may run more tests to verify the results and then suggest the next steps in care, lifestyle changes, screening, and prevention that you can take to reduce your and your family member’s risk.

If no DNA variants are found for the conditions being tested, this is reassuring, but there are other causes of cancer and heart disease that were not evaluated as part of this test. Lifestyle, family history, environment, personal medical history and other genetic conditions all contribute to your overall health and personal risk for disease. Therefore, continued routine screening for cancer and coronary artery disease is important. Please talk with your doctor about ongoing recommended screening for cancer and heart disease. If you have a personal or family history of cancer or heart disease, more comprehensive genetic testing may be appropriate. Please talk with your doctor about the option of additional testing.

You may still be contacted by your provider for additional follow-up. If you are concerned about other genetic risks, it is recommended you speak to your healthcare providers to explore other options for expanded testing.

No. ​​The results of your ancestry and traits may be different from what you understand to be true about yourself. This does not mean the information provided to you about these results or your health results is inaccurate.

It is important to understand that trait and ancestry results are estimates based on DNA patterns rather than definitive information. These results give insights into a person's genetic origins or predispositions. They do not guarantee the occurrence of specific ancestry or traits. While some traits are easy to predict based on genetic information, other traits are more complex and therefore more challenging to predict based on genetic data alone. Trait and ancestry results are different from Helix Health results. Helix Health screening looks for the presence or absence of specific genetic variants. Such variants have extensive evidence from the medical community linking them to risk for disease. 

Why doesn’t my ancestry and/or trait result match my actual ancestry or trait?
Genetic variations linked to ancestry and traits occur throughout the genome. They are responsible for the natural genetic diversity among people. These genetic variants estimate the most likely ancestry or traits that a person will have. They are not definitive and do not guarantee the occurrence of specific ancestry or traits.

Sometimes, the ancestry and traits we express do not match what is expected based on DNA screening. There are a few reasons for this. First, Helix screening may not include all of the genetic variants linked to a specific trait or ancestry. Also, there may be interactions between genes that are not yet fully understood. Genetic traits are often influenced by multiple genes making it difficult to predict precise outcomes. Finally, genetic traits can be influenced by the environment or other factors. These factors can interact with your genetic makeup and contribute to differences between the traits you express and the traits expected based on your DNA screening.

A result of “test not performed” means the sample that was provided did not meet the quality standards needed to complete the DNA sequencing at the Helix lab. Some examples of why this might happen include, but are not limited to, issues with processing the sample and extracting the DNA, issues with the sample being read in the sequencing machine, or issues with the sequencing data not being a high enough quality for interpretation. Every sample and its associated data is checked at multiple stages for quality, and a typical sample is given a “Test Not Performed” result only after it has failed multiple attempts.

Most of these issues may be resolved by collecting another sample and therefore we encourage any participant who receives a TNP result to provide another sample. If this issue occurs again, additional review of the issue will be completed in order to provide the best next steps aboutadditional sample collection.

If you have received a bone marrow or stem cell transplant as a treatment for blood cancer or another type of blood disease, it is recommended that you do not participate in this research study.
This study tests DNA from cells that are collected from your saliva or blood sample. These cells are often created by your bone marrow or by your stem cells. If you have received a bone marrow or stem cell transplant from a donor, your DNA and the DNA of your donor may be included in your specimen. Genetic test results may reflect the DNA of your donor or they may be inconclusive.

If you have been a bone marrow or stem cell donor, this would not impact your genetic test results.

You may withdraw from the study at any time. Your decision to withdraw will not result in any penalty or loss of benefits and will not affect the medical care or benefits to which you are otherwise entitled.

To withdraw, please send an email to the Healthy Nevada Project study team at RenownIHI@Renown.org.

If you withdraw from the study, you will no longer receive any emails or other communication as part of the study. Any information that has already been added to your medical record will remain in your medical record. However, no new information from the research study will go into your medical record. Your withdrawal from the project will be appropriately noted in your medical record.

Your privacy is very important to us, and we take many steps to ensure it is protected, such as:

• Your information (your genetic information and health records) will be stored in secure databases.
• We limit and closely monitor who can access your data.
• We limit who is allowed to see information that could identify you, like your name or contact information. 
• Researchers who have access to your data must be trained and certified to work with this type of research data.
• You can choose to withdraw and stop sharing your information at any time.

No, you can enter the study at no cost. Participants receive clinical grade genetic sequencing and screening for three of the most common hereditary risks, as well as regional ancestry and wellness insights at no cost. If we find any genetic variants indicating an increased health risk in your DNA, you will be contacted directly regarding your results and be offered no-cost genetic counseling with a licensed genetic counselor to discuss your individual results. Any follow-up care or treatment required after the disclosure of your results, such as through your primary care provider, will be charged to you and/or your health insurance in the usual manner.

The Healthy Nevada Project is powered by Renown Health. Renown Health is a locally governed and owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe, and northeast California.

During phase two, the personal genomics company, Helix, and a telegenomics technology and services company, Genome Medical, joined the project. Helix handles DNA sequencing and secure data storage while Genome Medical provides medically licensed genetic counseling to participants with positive findings.

The first phase of Renown’s Healthy Nevada Project was launched in September 2016 with 10,000 Nevadans joining the study. In March 2018, the second phase of the project was introduced with our partners at Helix for a more clinically focused experience, inviting 40,000 more Nevadans to participate. In May 2019, the third phase of the study began to include Las Vegas and southern Nevada.

Renown’s Healthy Nevada Project will continue indefinitely with an expectation of enrolling over 250,000 participants into the study.

We learned from the pilot study that we needed to integrate Renown’s Healthy Nevada Project into clinical care. To do this, we needed a vendor that could provide clinically actionable results to enrolled patients and their physicians. Renown’s clinical research teams will have greater depth and quality of DNA data thanks to Helix’s Next Generation Sequencing (NGS) technology and one of the world’s largest CAP- and CLIA accredited exome sequencing labs.

On average, visiting the enrollment website and reviewing the consent form takes about 15 to 20 minutes. You may visit the enrollment website on your own and review and sign the consent form. If you prefer you may schedule a virtual appointment with a Genomic Representative who will answer any questions you might have.

Once you visit a laboratory for your blood draw, the visit will take about 15 to 20 minutes.

• Saliva Samples: If you are providing a saliva sample, you cannot eat, drink (even water), chew gum or use tobacco products for 30 minutes prior to providing your sample.
  
• Blood Samples: If you are providing a blood sample, fasting is not required, but please do not schedule your visit within 30 days of receiving a blood transfusion or blood products. In addition, if you are scheduling your blood sample with other labs please follow whatever guidelines they provide for those tests.

Step 1: Sample Processing

• Your sample is sent to Helix’s lab for testing.
• Within a few days, you’ll get an email from Helix to set up your optional account.
• For convenience, you can also log in using MyChart.

Step 2: Sequencing & Storage

• Helix sequences and securely stores your genetic information.
• Results are available in your Helix account and also added to your medical record/MyChart.

Step 3: Results You’ll Receive

• You’ll see two types of results in your Helix account under the Results tab:
  1. Helix Ancestry & Helix Traits – ancestry and wellness insights (arrive first).
  2. Helix Health – clinical results for:
     • Familial Hypercholesterolemia
     • Hereditary Breast & Ovarian Cancer Syndrome
     • Lynch Syndrome
• Results may take up to 12 weeks, and you’ll get an email notification once they’re ready.

Step 4: If a Genetic Mutation Is Found

• If any mutation is detected, a study team member will call you directly.
• You’ll receive no-cost genetic counseling with a licensed counselor and additional resources.
• If no actionable findings are found, you won’t be contacted.

Step 5: Ongoing Research Participation

• From time to time, you may receive voluntary survey invitations by email.
• Some surveys may include extra incentives, which will be explained at the time.

Your results are only one piece of your health picture. It’s important to know:

• Test results do not change a previous diagnosis or your family risk.
• Cancer and heart disease may also be caused by:
  • Lifestyle
  • Family history
  • Environment
  • Personal medical history
  • Other genetic conditions
• The Healthy Nevada Project test:
  • Does not evaluate all genes linked to cancer and heart disease
  • May not identify all DNA variants in the genes tested

Next steps you may want to consider:

• Speak with a genetic counselor or your healthcare provider about your results.
• Ask if you need additional or different screening.
• If you have a negative test result but also have a clinical diagnosis, a diagnostic genetics consultation may help determine if more testing is appropriate.

About genetic counselors:
A genetic counselor is specially trained to:

• Help you understand how your genetic results may affect your health and family risk
• Discuss medical recommendations with you
• Guide you in sharing important information with relatives
• Provide support outside of the Healthy Nevada Project

A negative result is reassuring, but it is not the full picture. Only about 1% of the population will have the genetic variants that are understood to cause an increased risk for the conditions we are currently screening for. That means about 99% of the study participants will not have a pathogenic/likely pathogenic variant for the 3 conditions we are currently screening for. 

Why a negative result doesn’t mean “no risk”:

• Cancer and heart disease can also be caused by:
  • Lifestyle
  • Family history
  • Environment
  • Personal medical history
  • Other genetic conditions
• Routine screening for cancer and coronary artery disease is still important.
• Even without genetic risk factors:
  • 1 in 8 biological women will develop breast cancer
  • 1 in 25 people will develop colorectal cancer
  • Nearly 1 in 4 people will develop coronary artery disease

Important reminders:

• If you already have a diagnosis of Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, or Familial Hypercholesterolemia, do not disregard those results — this study does not overturn them.
• Science is evolving. Not all genetic variants linked to cancer or cardiovascular disease are currently identified or screened for.
• Share any personal or family history of cancer or heart disease with your medical provider. They can help determine if additional genetic testing is appropriate.

Looking ahead:

• The American College of Medical Genetics lists many other conditions that can be managed through genetic screening.
• Renown’s Healthy Nevada Project currently reports on the top three:
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Lynch Syndrome
  • Familial Hypercholesterolemia
• With the advancement of genomic medicine, more hereditary risks may be reported in the future.

Unless explicitly stated differently in the Informed Consent for Renown’s Healthy Nevada Project, we follow the privacy policies of Renown Health. Any data obtained from your participation in this study is used for research purposes as outlined in our  Notice of Privacy Practices.

How Your Privacy Is Protected

• Renown has obtained a Certificate of Confidentiality (CoC) from the National Institutes of Health (NIH).
  • This allows researchers to legally refuse to disclose your information in federal, state, or local proceedings — even if subpoenaed.
  • Researchers will use this Certificate to resist any demands for information that could identify you.
• For research purposes, all information is de-identified:
  • Your Helix account and any products you purchase in the Helix Store are not accessible to Renown researchers.
  • Helix only shares the parts of your genome that are relevant to this study.
• If findings are considered important for your health, and you have given consent:
  • The Principal Investigator may re-identify you in order to share information through trained medical staff.
  • Examples include increased risk of serious conditions such as cardiovascular disease or cancer.
• Federal and state laws also protect your protected health information (PHI).

Yes, but you will be under no obligation to participate in future research studies and may opt-out of being contacted regardingadditional research studies at any time by contacting the study team directly. Study participants are often the first to be offered new research opportunities that may benefit them.

For example, Renown may open additional clinical trials in specific disease areas, such as our M/NASH Liver Disease Study, to participants interested in taking part.

No, it will not. Renown’s Healthy Nevada Project is a research study and not a publicly available database. Any data shared with approved research partners is kept de-identified to maintain your privacy.

Your Rights Under GINA

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects you from genetic discrimination in health insurance and employment.

What GINA protects:

• Health insurers cannot request, require, or use genetic information to:
  • Decide if you are eligible for coverage
  • Set your premium or contribution amounts
  • Change your coverage terms
• Employers cannot use genetic information when making decisions about hiring, firing, promotions, or job assignments.
• With these protections, you can feel comfortable sharing family health history with your doctor or loved ones.

What GINA does not cover:

• Life insurance
• Disability insurance
• Long-term care insurance

🔗 To learn more about your protections, visit ginahelp.org.

Signing the research consent form does not mean that Renown Health or Helix will share your research information with law enforcement. Renown Health and Helix take genetic privacy very seriously and would only share your research information with law enforcement in connection with a valid legal process requiring disclosure of such data or where disclosure is required by law (like a valid warrant or court order). All such requests would be reviewed on a case-by-case basis, and you would be notified of such a request before sharing any data occurs unless Renown Health or Helix is legally barred from doing so. Helix will object to any request that does not meet legal standards.

Helix has never been contacted by law enforcement to request personal information of a research participant. Most companies like Ancestry and 23andMe publish transparency reports with information about requests from law enforcement. For more information, please review these reports.

There are very specific edge cases that might be adjudicated in a court where law enforcement could perhaps attempt to break our Certificate of Confidentiality: subpoenas related to child endangerment, capital murder, etc. This has never occurred in relation to Renown’s Healthy Nevada Project.

No certificate of confidentiality.

Before or during your appointment, you can download and review an Informed Consent Form (available in English and Spanish) that explains your role in this study. We'll ask for your signature at that time.

Consent Forms:

• English Consent Form
• Forma de Consentimiento en Español