Helix Health Product Consent

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• Genetic Information: Your sequenced DNA and any interpretation of the data. We derive your sequenced DNA from your saliva sample. We store your Genetic Information for you to provide genetic insights you have agreed to receive.
• DNA: Deoxyribonucleic acid. It is the hereditary set of instructions that every parent passes on to their biological children and contains the genetic instructions for how our bodies grow and function over time.
• Genes: Sections of DNA that may influence specific traits or health conditions.
• Variant: A variant is a genetic change, or variation, in DNA that most people do not have. Some variants can lead to an increased chance of developing a certain health condition.

The Helix Health test looks at specific locations in your DNA to tell you if you have any identifiable changes, or variants, in your DNA that could put you at increased risk for developing certain hereditary conditions. Specifically, the test will tell you about three conditions: 

• A hereditary form of very high cholesterol that causes heart disease at an earlier age than the general population, known as familial hypercholesterolemia (FH)
• A hereditary form of breast and ovarian cancer syndrome (HBOC), specifically the BRCA1 and BRCA2 genes
• A hereditary type of colorectal cancer known as Lynch syndrome

Helix Health will tell you if you have inherited specific variants related to any of these three conditions. These conditions have been selected because they are actionable. That means if you know you have an increased risk based on your DNA, there are steps you and your healthcare providers can take to reduce or address your health risks. The health risks associated with these conditions are part of a spectrum—some variants can cause a higher risk than others. 

Often, your risk for developing certain health conditions is estimated based on your family’s medical history. While very useful, our knowledge of our own family history can be incomplete for a number of reasons. For example, the exact diagnosis given to a relative may not be known by all family members, either because the individual didn’t want to share that information or simply because medical terminology can be difficult to remember. It’s also possible that members of your family have a genetic variant that increases their odds of disease, yet they never developed symptoms. In some cases, having a variant doesn’t guarantee that you will develop symptoms, meaning you and your family may be unaware of your increased risks. Helix Health can help to fill in these gaps.

If you have a personal or family history of a condition covered by this test, you may want to speak with a genetic counselor or your doctor about whether additional or different genetic testing may be appropriate for you.

A genetic counselor is a medical professional specifically trained to help you understand how your genetic information may impact your health, as well as your family’s. A genetic counselor can review your personal and family history, help you understand your results, discuss medical recommendations, and help you put those into action with your healthcare provider(s). They can also help you understand how your results may, or may not, affect your biological relatives, and how you can approach sharing any important information.

When your results are ready, you will be able to login using your secure username and password. The results will tell you if any variants were found in one of the tested genes related to the three conditions. Helix works with a clinical laboratory as a service provider to assist with genetic interpretations and confirmatory testing to generate your FH results. The name of the interpretation laboratory will be on your report.

Most people do not have variants in these genes. In fact, only about 1-2% (1 or 2 people out of 100) will be found to have a variant. This means that more than 98% of people will learn that they do not have an increased risk for one of these conditions based on this test.

Some people will learn that they have an inherited risk for one of the three conditions. And rarely, someone may learn that they have inherited more than one variant, either for the same condition or for different conditions. Your report will guide you through some important information to help you understand what your result means for you, for your family, and what you can do.

If you are found to have an inherited risk for one of the conditions covered by this test, there are specific actions you and your doctor may choose to take depending on many factors such as your age, sex, and personal medical history. These can include steps such as early screening, risk-reducing medications, and other methods of prevention or early detection.

These conditions can run in families, so your results may or may not uncover health risks for your biological relatives. If you learn you have an inherited risk from this test, sharing your results with your family can be an important step towards helping them take action in their own healthcare.

Whether you are found to have an increased risk for one of these conditions, or no variant is found, you may have questions. Your report will tell you how to connect with a genetic counselor or qualified healthcare provider who can support you with your results.

This test will tell you about inherited risk factors that you might not otherwise know about based on family history or standard medical screening tests. You may learn that you have an increased chance of developing certain types of cancer or heart disease at an earlier age than the general population. This information may allow you to screen for, prevent, or minimize the impact of these conditions. Your insurance may or may not cover these interventions.

If you have a variant in one of the tested genes, your parents, siblings, and children may also be at risk for the condition. Sharing your information with relatives can also help them. They will be able to seek out genetic testing and receive appropriate screening, prevention, or medical intervention.

Helix Health will not tell you if you have, or will definitely develop, any of these health conditions. Based on your test results, you and your healthcare provider can determine what steps are appropriate to assess your current health and address any future health risks. 

There are risk factors that are not covered by this test.

The test looks for specific inherited forms of cancer and high cholesterol, but it does not check all known genes that are associated with cancer or heart disease. It also does not check for all DNA variants that may be associated with these conditions.

There are also common genetic risks (that we all have in some combination) that are not included in this test. There may be other inherited factors that have not yet been identified. Your family history is also important, because there can be other inherited causes that are not detected by this test. And, other factors such as lifestyle, environment, and your personal medical history also play a role in determining your overall health risks.

There are times that a variant is found but it is not possible to determine whether it is disease-causing (known as pathogenic) or not (known as benign). These results are called "Variants of Unknown Significance” (VUSs). Helix Health does not report VUSs because no medical action can be taken based on such a result.

Genetics is a field that is evolving quickly. Scientists are always discovering new details about how to interpret DNA data. Helix Health is based on the current state of knowledge. As scientific knowledge improves, the interpretation of your results may change. From time to time discoveries are made that show that some previous discoveries are not valid, or that a VUS may actually cause one of these conditions. That means there is a small chance that you could learn insights in the future that are not available today. 

There is a chance you could learn something about yourself that you didn’t want to know. You may learn about a health risk that you were not aware of. You may need to take medical action based on your results that can require additional medical resources and carry costs that may not be fully covered by insurance.

Learning about your inherited risks can impact your family. If you are found to have a variant in one of the tested genes, your biological relatives are at risk for having the same variant. Everyone reacts to this kind of information differently, and it can have an impact on family dynamics.

Even if you are not found to have a variant, you or your relatives may still be at risk for developing cancer or heart disease. You should consult with your doctor or a genetic counselor to understand more about whether additional testing or screening may be beneficial to you or your family. Individuals and families who have a personal history of cancer or heart disease are especially recommended to discuss this history with a doctor or a genetic counselor.

There is a chance that you may learn that your relation to certain biological relatives is not what you thought. For example, you could discover that you or someone in your family is not related by blood to the rest of the family.

Under the Genetic Information Nondiscrimination Act (GINA), your health insurer cannot use genetic testing information in decisions about coverage and health premiums. If you work for a company of 15 or more people, your employer cannot ask you about your Genetic Information. They are also barred from using any Genetic Information in hiring or other employment decisions.

This restriction only applies to employment and health insurance companies. For example, companies that offer life, long-term care, or disability insurance are not covered by GINA. Neither are the US Armed Forces. Some states have safeguards on top of the safeguards in GINA. You should be aware of the laws in your state and be careful with whom you choose to share your Genetic Information.

There is a risk of a security event in which someone may access your data without your consent. These data could include your name, contact details, or Genetic Information. When combined, these data could allow someone to connect your Genetic Information back to you. Helix takes active steps to minimize the risk of such an event.

I have read this consent form or have had the form read to me. I understand and agree to the purpose, risks, benefits, and limitations of this test.