Frequently Asked Questions

What is Uniquely You?

Uniquely You is a community health research program, supported by LCMC Health to help improve the health of the participants and the community we serve. Through no-cost genetic screening, the program looks at how your DNA could impact your health. The information we gain may help us improve personalized healthcare and support new research discoveries.

Get started with Uniquely You today

Who is eligible to join?

Uniquely You aims to enroll 100,000 participants who are over 18 years of age in this community health research program.

Is there a cost involved to participate?

No. Because this is a research program, there is no cost to participate, and the genetic screening provided will not be billed to your health insurance or to you. If your sample collection occurs during a clinic visit, your participation will not affect normal charges for that visit.

If you test positive for one of the conditions being screened, you will be offered a genetic counseling appointment at no cost. However, any follow-up beyond the initial genetic counseling appointment will be considered clinical care, and you and/or your insurance company may be responsible for payment.

Do I have to participate in Uniquely You?

No. Research studies include only people who choose to participate, so Uniquely You is completely voluntary. It is your choice whether or not you want to take part in this study, and your decision will not impact your care or employment at LCMC Health.

How do I sign up?

We want to make sure you understand what is involved in the study so you can make an informed decision about your participation in the research. Signing up is easy and something you can do from home. If you choose to participate, we will ask you to answer a few questions to confirm you are eligible to participate. You will then be provided with a link to review and sign the Uniquely You research consent form, which provides confirmation of your informed consent.

The consent process:

Create an LCMC Health Patient Portal (MyChart) account if you don’t already have one. You can find instructions at LCMChealth.org/PatientPortal.

Click on the “Join Now” button on this website by clicking here. This will bring you to the enrollment website from our partner, Helix. You will be asked to confirm your identity on the next step by logging into your Patient Portal (MyChart) account.
- If you received an invite to join Uniquely You in your MyChart account, you may also click the link in that message to take you to the enrollment website.

After you log into your Patient Portal (MyChart) account, some of your contact and personal information will be shared with Helix to assist with the enrollment process. You will then visit Helix’s enrollment website where you can learn more information about Uniquely You and start the enrollment process by answering questions to see if you are eligible.

Once your eligibility is confirmed, the next step is to review the research consent form. It is important to read over the consent form carefully. If you have any questions about the study or the form, you can contact a member of the Uniquely You study team by phone at 504.702.3538 or UniquelyYou@LCMChealth.org.

Once you are ready and all of your questions have been answered, sign the consent form. You will be sent a copy of your signed consent for your records via email, and it will be available in your medical record. You will then receive a MyChart message with next steps for providing your DNA sample at a participating LCMC Health lab.

Please note: The information provided before informed consent is signed may be stored by LCMC Health and/or Helix to keep track of potential participants and may be used to contact those who are interested. Only those who are eligible may sign an informed consent form to participate.

How do I provide my sample?

Please walk in to your local LCMC Health lab to complete your blood draw.

Please note:

You may eat and drink before the test.
Please do not provide a sample within 30 days of receiving a blood transfusion or blood products.
If you have any questions, please contact the Uniquely You study team by emailing UniquelyYou@LCMChealth.org or by calling 504.702.3538.

I provided my sample. What's next?

Once your sample is collected, LCMC Health will send it to our partner, Helix. Helix will complete DNA analysis, also known as sequencing. Sequencing reads the code contained within the DNA so that it can be used for research. You will also receive an email from Helix offering you the opportunity to create an optional Helix account.

Will I get results back from Uniquely You?

Yes. You will receive health results that will indicate if you have inherited certain risk factors in your DNA, meaning that the risk may have been passed from generation to generation in your family. Your family history alone, and standard medical screening tests, do not always identify risks for these conditions. Specifically, the screening will tell you about your genetic risk for the following three conditions that the US Centers for Disease Control and Prevention (CDC) and other medical professionals consider to be important enough to warrant further investigation of treatment:

Familial hypercholesterolemia (FH): A hereditary form of very high cholesterol that increases your risk of early coronary artery disease and heart attacks.
Hereditary breast and ovarian cancer (HBOC): A hereditary form of breast and ovarian cancer, specifically linked with abnormalities in two genes (BRCA1 and BRCA2). Other cancers associated with these genes include prostate, pancreatic, and melanoma type cancers.
Lynch syndrome: The most common cause of hereditary colorectal (colon) cancer. People with Lynch syndrome are more likely to get colorectal cancer at a younger age and are also at an increased risk of developing endometrial, ovarian, upper GI, brain, pancreatic and/or other cancers.

In addition, if you sign up for a Helix account, you’ll receive information about your genetic regional ancestry and how your DNA may influence certain traits, such as your caffeine sensitivity and sleep patterns.

How often do participants test positive for one of these conditions, and who will help me interpret the results and determine next steps?

You and your LCMC Health care provider will receive health results from the genetic screening that will indicate if you have inherited certain risk factors in your DNA.

Approximately 1-2% (one to two people out of 100) will be found to have a risk for one of the inherited cancers or the heart condition included in this study. If your results show you are at an increased risk for certain conditions, a member of the LCMC Health Uniquely You team will contact you about your results and you will be able to schedule a genetic counseling appointment at no cost to you or your insurance.

Your health care provider may refer you to a specialist for more information, genetic counseling and/or additional screenings, if needed. You would be responsible for the cost of these appointments.

How long does it take to receive results?

The process typically takes three weeks from Helix receiving your sample to the time you receive your genetic screening results, though it could take up to 6 weeks. Typically, your Helix Ancestry and Traits results are ready within eight weeks of the Helix lab receiving your sample. These results are available to you if you have created an optional Helix account. It may take longer before your health results are ready to view, as extra steps are taken to ensure your health results are accurate.

How comprehensive are my results?

The genetic screening done for Uniquely You focuses on three specific conditions:

Hereditary breast and ovarian cancer syndrome
Lynch syndrome (increased risks for colorectal and other cancers)
Familial hypercholesterolemia (very high cholesterol)

We focus on these three conditions because they occur often enough in the general population. Plus, if you discover you have one of these conditions, there are specific actions you can take to reduce your risk.

This genetic screening does not analyze all the potential risks linked to your DNA. It is not meant to replace in-depth genetic testing.

Talk to your health care provider if you are concerned about your risks or have a previous diagnosis of any of the tested conditions.

My ancestry and/or trait results differ from what I expected. Does this mean my Helix Health results are wrong?

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.

What if I have a personal or family history of heart disease or cancer?

If you have a personal or family history of a condition covered by this screening, it is important to know the results of this screening do not change a previous diagnosis or any family history risk you might have. This is because there are other causes of cancer and heart disease that were not evaluated as part of this screening. For example, lifestyle, family history, environment, personal medical history, and other genetic conditions all contribute to your overall health and personal risk for disease. In addition, the screening provided as part of Uniquely You does not evaluate all genes associated with cancer and heart disease. Also, this screening may not identify all DNA variants in the genes that were tested.

You may want to speak with a genetic counselor or your health care provider about the results of this screening and whether additional or different genetic screening and general screening may be appropriate for you. In particular, participants with a negative genetic screening and a clinical diagnosis of one of the conditions screened for by this program are recommended to consider a diagnostic genetics consultation to identify whether additional genetic screening or screening recommendations may be beneficial.

A genetic counselor is a medical professional specifically trained to help you understand how your genetic information may impact your health and the health of your family members, discuss medical recommendations, and discuss how you can approach sharing any important information with others. Those communications would be separate from Uniquely You.

Are the results I get back from Uniquely You with LCMC Health the same as a genetic test my health care provider would order?

No. This is a screening test. It does not detect all genetic variants related to hereditary cancer risk or cardiovascular disease. Based on your personal and family medical history, additional risk assessment or a more comprehensive diagnostic genetic test may be appropriate for you.

You may want to speak with a genetic counselor or your health care provider about whether additional or different genetic screening and general screening may be appropriate for you. In particular, participants with a negative genetic screening and a clinical diagnosis of one of the conditions screened for by this program are recommended to consider a diagnostic genetics consultation to identify whether additional genetic screening or screening recommendations may be beneficial.

Can my genetic sequencing completed through this research program be used for other tests in the future?

Our partner, Helix, performs Exome+ sequencing on participant samples. This screening reads the DNA sequence of most genes (plus many other regions of the DNA). An individual's DNA sequence is also called their genetic information. Through involvement in this study, participants will receive DNA screening results for three medical conditions. These conditions include a genetic form of breast cancer, colon cancer, and high cholesterol.

There are no additional genetic test results planned for return through this research program at this time. This may change in the future if additional medical conditions become appropriate for general population screening. Participants will be notified of any updates before receiving new results.

Helix will store participants’ DNA sequence results for an unlimited time. Since participants’ genetic information has been sequenced and stored, it will be possible to use that information for future clinical genetic testing. Helix is actively working with LCMC Health and other partnering health care institutions to offer opportunities for patients to learn more about their genetic information in the future. Such future clinical testing would only be performed at the request of an ordering health care provider and with the additional consent and payment by the patient.

My results say that the test was not performed (TNP), why is that?

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. 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 about additional sample collection.

Why can't I participate if I had a bone marrow transplant or stem cell transplant from a donor?

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 screening 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 screening results.

What if I participate now and change my mind later?

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 Uniquely You team at UniquelyYou@LCMChealth.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 program will be appropriately noted in your medical record.

How is Uniquely You different from historically unethical research activities, many of which impacted vulnerable communities?

Uniquely You is considerably different in the following ways:

Each participant has to volunteer to participate. No data or samples are being used for research without a participant agreeing to participate.
Each participant must review and complete a research consent form prior to their enrollment into the community health research program and prior to data and samples being used for any research purpose.
- At the time of previous unethical research activities, informed consent for research was not standard practice. Ethics boards that review research were not fully established, and researchers did not have to abide by the standards that we have today. Uniquely You is reviewed by an ethics board called an Institutional Review Board or (IRB). They must abide by the federal rules that oversee human subjects research. The application that is submitted to the IRB must include all information about the research program as well as all documentation that describes the research program.
- Because of this review process, we now have many rules to abide by to run a research program ethically and in compliance with the rules of our institution and the federal government. This includes standards on how we inform participants if there are any changes to the research since they provided consent, including new risks or new benefits.
- In addition, we are transparent about all aspects of the research program. The consent form includes detailed information about participation, the risk and benefits of the study, what information a participant will and will not receive and what happens if there are discoveries made from the information provided in the research program.
- Participants are informed from the beginning that they can withdraw from the research program at any time. Therefore, they are in control of when they start participating and when they stop participating.
Participants are encouraged to reach out to a Uniquely You team member to have their questions answered so they can be informed about the research in all of the ways necessary.

Uniquely You values representation and inclusion in this program, so that all community members can not only have access to proactive health care learnings for their individual health, but also so that the actionable research resulting from this program can be applicable to enhancing the standard of care for all.

Privacy and Data Protection

Will my results impact my health insurance?

No. The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, this law doesn’t protect you against genetic discrimination by companies when they consider selling you life insurance, disability insurance, or long-term care insurance. These companies must still abide by GINA when it comes to health insurance.

How will my information be used?

The information you contribute to Uniquely You will be used by researchers to study a wide range of questions around how DNA can impact health. The databases created in this research program will be used for future research by our precision health care partner Helix, by us, and by other members of the Helix Research Network. The Helix Research Network is a network of health systems that works with Helix to create and offer community health research programs to their patients and members of their community. Uniquely You is a Helix Research Network study. That means that, by agreeing to participate in the study, you are agreeing to have your information included in future research programs that are approved by us and by Helix.

Researchers outside of the Helix Research Network may also study your coded information and samples but will not have access to information that directly identifies you. These researchers may work for health systems, universities, companies like drug companies, and other foundations or groups interested in research. Any sharing of information outside of the network will be carefully reviewed and approved to make sure it is ethical, secure, and protects your privacy.

We may share discoveries that are made by LCMC Health researchers through our website and newsletters.

How do you protect my privacy and confidentiality?

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

Your personally identifiable information and data (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.

Will my results of my participation in the study impact my employment?

With few exceptions, GINA prohibits employers from discriminating against their employees on the basis of genetic information in any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. The law similarly prohibits labor organizations from excluding, expelling, or otherwise discriminating against an individual based on genetic information.

It is important to note that GINA’s employment protections do not extend to all employees or in all circumstances. Most notably, these protections do not apply to employees at companies with fewer than 15 employees or to active members of the U.S. military.

Will the results of my participation in the study impact my employment at LCMC Health?

No. Your decision to participate in, decline, or withdraw from the research study is completely voluntary and not required by LCMC Health because of your employment. In making your voluntary decision, we encourage you to carefully review the above-referenced FAQs which, along with the Informed Consent form, more fully explain the research study and summarize risks and benefits of participating in this study, along with other important information, including your rights under the Genetic Information Nondiscrimination Act (GINA).

Your voluntary decision will not be included in your LCMC Health employment record (or be accessible to your manager(s)), nor will any results of your participation in the study (should you choose to participate). Your voluntary decision will not affect your compensation, benefits, job performance evaluation, or any other decision related to your employment. A voluntary decision not to participate in this study will not result in any penalty or loss of employment and will not affect the medical care or benefits you receive and to which you are otherwise entitled.

Will the results of my participation in the study impact my life insurance, disability insurance, or long-term care insurance?

Currently, federal and Louisiana law protections against discrimination based on genetic information by health insurers do not extend to providers of life, disability, and long-term care insurance. That means companies offering these kinds of insurance may request access to genetic information in your medical record as part of the insurance application process (including information generated as part of your participation in this study) and may legally consider this information in deciding whether to extend your coverage or in determining the price they charge you.

If you already have an existing life insurance, disability insurance, or long-term care insurance policy, new information about your health (including genetic information) generally may not be used to deny you continuing coverage under those policies. However, the terms of individual policies vary significantly, and you should read your policy carefully to understand how results could impact your coverage or insurance rates.

What measures does Helix take to keep research study data safe?

If you decide to participate in the Uniquely You study, your information will be stored in databases that are maintained and monitored by a team of IT and security professionals who are committed to safeguarding the information stored in those systems. These systems include numerous technical, physical, and administrative safeguards that meet, and in some cases exceed, industry best privacy and cybersecurity practices, including standards established by the National Institutes of Science and Technology (“NIST”), the Association of International Certified Professional Accountants (“AICPA”), and applicable Louisiana and federal laws, such as HIPAA.

Some of the technical safeguards we’ve implemented include rigorous identification, authorization and access controls, audit and logging procedures, configuration management, system and communication protections and endpoint monitoring, data loss prevention systems, encryption of data at rest and in transit, and vendor risk management procedures. Although we generally do not share the details of how these controls and safeguards have been configured, we can share that our privacy and security programs are reviewed annually by third party auditors to ensure our safeguards are operating as expected and in a manner consistent with industry standards.

How is Helix's clinical health screening different from ancestry and trait testing?

When you participate in Helix Research NetworkⓇ screening through your health care institution, you will receive two types of genetic screening with very different purposes and quality standards:

Helix Clinical Health Screening:

Designed to support medical decision-making
Meets the stringent laboratory quality standards
Accredited by the College of American Pathologists (CAP)
Certified under the Clinical Laboratory Improvement Amendments (CLIA)
Undergoes validation for accuracy and reliability
Looks for disease-causing genetic variants that can impact your health
All positive test results undergo confirmatory testing

Helix Ancestry and Trait Testing:

Designed for fun and personal interest
Provides estimates and probabilities, not medical diagnoses
Results describe tendencies (like food preferences or ancestry estimates)
Uses different methods and reference data than clinical testing

Think of it this way: recreational results are like interesting family stories that might have some variations in the telling. Clinical health screening test results are like medical records that must meet strict accuracy requirements because health care providers use them to guide your care.

Our primary focus is clinical health screening. We dedicate extensive resources to validating our clinical results because we understand that healthcare decisions depend on accurate, reliable information. The Helix Exome+Ⓡ assay has been analytically validated for clinical use, as described in our validation studies which are available at helix.com/research.

If you have questions about your clinical health results, please discuss them with your health care provider or genetic counselor.

Why do my Helix ancestry or trait results differ from those found by other laboratories?

Helix dedicates extensive validation and quality oversight to our clinical screening to ensure accuracy and reliability. Helix recreational ancestry and trait results have some inherent limitations. However, these limitations do not apply to our clinical health screening.

It's not uncommon for ancestry and trait results to vary between different testing companies. Here's why:

For ancestry results:

Each laboratory uses a unique "reference panel"—a collection of DNA from people with long histories in specific parts of the world. Your DNA is compared to this reference panel to estimate your genetic ancestry. Because each testing company uses different reference panels with different genetic markers, you may see variations in your results.

Different companies use different datasets to train their ancestry models. Helix ancestry testing was developed for recreational use. Certain regions—especially those showing low percentages or areas like Sardinia and Sicily—may have higher margins of error.

For trait results:

Trait results (like cilantro aversion or asparagus odor detection) are based on genetic variants called SNPs (single nucleotide polymorphisms). Different companies may test different SNPs for the same trait, or they may interpret the same SNP differently based on varying evidence standards. This is why your results might not match completely between companies.

For example, cilantro aversion is influenced by multiple genetic variants and environmental factors like smell receptor sensitivity, so it's normal to like cilantro even if a genetic test suggests you might not.

I'm concerned my samples might have been mixed up because my test results don't match what I know to be true about myself. How can I be sure?

We understand that unexpected results can be concerning. Here's what you should know:

Sample mix-ups are uncommon due to the quality control checks that Helix employs with every sample we test. Sample integrity is of critical importance to us, and we have multiple safeguards in place:

Helix is accredited by the College of American Pathologists (CAP)
We are certified under the Clinical Laboratory Improvement Amendments (CLIA)
Both certifications require laboratory quality standards that govern proper handling and testing of clinical samples, including DNA

If your ancestry or trait results seem unexpected:

Remember that these recreational results can vary between companies and may not always match your expectations. Ancestry estimates are based on probability, and trait results describe tendencies, not certainties.

If your clinical health results seem unexpected:

Please discuss your concerns with your healthcare provider or genetic counselor. They can help you understand what your results mean in the context of your personal and family health history.

If you'd still like additional reassurance:

Helix can initiate an internal review to confirm that your sample was received, processed, and reported correctly. Your healthcare provider can contact clinicalsupport@helix.com with your name and date of birth to begin this review process.

We are committed to providing accurate, reliable results and any additional reassurance that may be helpful to you.

Who do I contact for help?

For questions related to Uniquely You, please contact the research study team at 504.702.3538 or at UniquelyYou@LCMChealth.org.

For questions related to the informed consent process and using the informed consent website (including updates to email and phone number), and for questions related to the shipment of a sample collection kit, or creating or accessing an optional Helix account - Please contact Helix customer support by phone, email or by filling out an online request: 844.430.0468 // support@helix.com // Online form: https://support.helix.com/s/contactsupport

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Share your Uniquely You story

We believe in the power of shared experiences. By participating in Uniquely You with LCMC Health, you’re helping us learn how we may be able to improve the standards of health care for everyone. We’re excited for how this work will impact the health of our families, friends, and community for generations to come. We’d love to hear about your experience with Uniquely You. Sharing your story can help spread awareness about this community research program and encourage others to join. No story is too big or too small to share. Please email UniquelyYou@LCMChealth.org if you have a story to share [or click here].