Informed Consent

We ask you to provide your informed consent to ensure that, before purchasing GeneYouIn’s genetic testing and consulting services, you are not only aware of the benefits, but also understand the limitations and potential risks. Please carefully review the information described below before you purchase any of our services.

It is important for you to know that the services provided by GeneYouIn do not establish a doctor-patient relationship and are not medical advice. GeneYouIn does not provide medical advice, diagnosis, or treatment and as such is NOT a healthcare provider. Always consult your doctor if you have any questions regarding your medical condition, and before starting, stopping, and/or altering dosage of any treatment that has been prescribed to you.

Our genetic testing is not intended to be used for disease diagnostics. It is geared towards determining your personal disease risk profile. Therefore, it provides you with information to assist you in adjusting your lifestyle or initiate appropriate treatment recommended to you by your healthcare provider. Thus, your results will not tell you whether you currently have or will definitely develop any of the conditions set out in the test results. The overall risk of developing common health conditions is determined by the genetic component as well as many additional factors including your lifestyle, diet, and environmental factors. Please note that our risk estimates do not account for any of those additional factors.

1. Purpose of Services

Your overall health and well-being is in part determined by your genetic make-up. Genes are segments of your DNA that influence certain traits like your hair color or eye color, but can also influence how likely you are to develop certain diseases over your lifetime, or how your body responds to specific medications. Your lifestyle and environment play a role as well; however, some conditions have a stronger genetic component than others. Complex diseases that develop later on in life such as cardiovascular (heart-related) disease, autoimmune diseases (i.e. diabetes and rheumatoid arthritis), cancer, and others are determined by the interplay of your genes and the environment. By modifying your environment, i.e. exposure to risk factors such as tobacco, alcohol, and chemical pollutants, it is possible to reduce your risk of some diseases. GeneYouIn offers tests that may help you understand what your specific genetic risks are, so that you can make changes ahead of time. By agreeing to this Informed Consent, you understand and agree that:

  • We will use your biological samples for analysis of genes and biomarkers to identify associations with specific health conditions and predicted responses to certain medications.
  • The genetic analysis techniques we employ are not yet approved by Health Canada for clinical diagnostics and are available to you on a research basis and for information purposes only.
  • We will disclose to you only the disease predispositions that are currently “medically actionable”, i.e. have known interventions or treatments that may help to delay disease onset or slow disease progressions such as cardiovascular, autoimmune diseases, and cancer.
  • The risk information provided by the GeneYouIn’s PillCheck, VitaSeq and PregnaSeq services is based on current scientific knowledge, and this information is changing and improving over time. Your possible projected risk for specific conditions and medication responses is based on what is currently known and accepted in the scientific literature about genetic contributions to these conditions.
  • The functional consequence of many rare mutations is not yet known and computational methods that we employ to assess the disease liability of these mutations have substantial limitations. Therefore, you must be aware that new studies are likely to provide new insights that will possibly change your risk estimates.
  • Our risk estimates do not account for the impact of your behavior, diet, and environment. Common, complex health conditions and medication responses are determined by a combination of genetic factors, your behavior, diet, any other health conditions you may have, or medications you are currently taking, have taken, or will take.
  • Accuracy of the DNA analysis depends on several factors outside of the laboratory’s control, including how carefully you follow the cheek swab collection instructions provided by GeneYouIn. Insufficient quantities of DNA and poor results are likely if you smoke, eat, drink or brush your teeth shortly before collecting the sample.
  • You understand that you will not receive any compensation as a result of having your DNA analyzed, Your Genetic Data, or your Phenotype Information analyzed, or from any other research performed using your Genetic Data or your Phenotype Information.
  • You provide your consent for research in which we analyze your genetic data and phenotype information in order to discover or validate associations between certain genetic variations and diseases. These studies will improve the accuracy of our predictions for you and other customers. As the number of our customers grows, our ability to study their combined genetic data and phenotype information further advances scientific and medical research, thus improving health care. You authorize GeneYouIn to use and share your anonymized genetic and clinical data with research organizations. If you decide that you do not want us to share your anonymized genetic and clinical data, please initial the check box next to this bullet point. ☐

2.1 Description of our services

GeneYouIn will run a test using a sample from you (a simple swab from the inside of your mouth) and uncover your genetic profile. We then use various methods to identify specific biomarkers that are associated with certain health conditions and run this alongside your personal profile. We offer different tests (described below) that provide specific insights to your health. GeneYouIn analyzes certain variants in your DNA in order to:

  • assess your genetic risk estimates for specific health conditions;
  • or potential response to medications.

2.2 GeneYouIn’s PillCheck test

This service uncovers how your genetic profile matches to known information about specific drug absorption, metabolism, and action. Based on this information, your healthcare provider can work with you to confirm whether a medication is well suited for you. For example, many conditions have more than one medication available to treat symptoms. By taking the Pill Check test, you can work with your health care provider to see which one of the medications will be effective for you based on your genetic makeup. This helps reduce the trial and error process, and allows you to achieve positive results faster. Our service is not suited for clinical diagnostics and is only a tool to assist you and your physician to optimize your healthcare. Since medications act through complex metabolic pathways and there are a limited number of genetic markers included in some tests, the result may not represent all the genetic factors that play a role in the drug response. As researchers identify new markers that meet GeneYouIn’s strict scientific criteria, those markers will affect your drug response, but some of these markers might be not included in the PillCheck requiring retesting.

Additional factors, such as other medications or supplements you take, lifestyle, diet, and other health conditions may affect the drug response. Our risk estimates do not account for these environmental influences. Please note that accuracy of prediction for some tests is dependent on your ethnicity. Since the Pill Check tests analyze only known common variations, people with specific ancestries may have additional variations in their genome that are not captured by these tests.

2.3 GeneYouIn’s VitaSeq test

Have you ever wondered what your chances are of developing a disease or condition that appears in your family history? Doctors rely on your family history of disease when determining what may be affecting your health.

This test explores and identifies potential diseases causing mutations in your genes. We apply genome sequencing technologies to analyze the gene coding regions and identify variations in your genome. Everybody has millions of variations in her/his genome: these variations make us unique but only a small fraction of these are medically relevant. Some of these genetic variations, such as Single Nucleotide Polymorphisms (SNPs) Copy Number Variations (CNVs), and deletions or rearrangements in the genome, have been linked with common complex diseases such as type 2 diabetes, cardiovascular disease, and cancer in large-scale genetic studies. Similarly, such variations have been linked to drug responses and the risk of developing adverse side effects to medications. This information may be useful in guiding therapy, including specific drug selection or dosage for many medications including some blood thinners, cholesterol lowering drugs, and cancer treatments.

Please note that the vast majority of variations we analyze are inherited from your biological parents and may be transmitted to your children. Therefore, it is important for you to be aware that your genetic information and the analysis thereof may impact and affect your siblings, parents, and children. Please keep this in mind prior to ordering our genetic testing services and sharing those results with your siblings, parents, and children.

It is also important to realize that a result indicating that you have a below-average chance of developing a specific condition during your lifetime does not guarantee that you do not have or will not develop the condition. Therefore, it is important that you continue to maintain a healthy lifestyle and continue regular medical check-ups with your physician or other qualified health-care provider. GeneYouIn does not provide medical advice, diagnosis, or treatment. You should consult your doctor if you have questions regarding any medical condition before starting any new treatment and before stopping any treatment that has been prescribed for you.

2.4 GeneYouIn’s PregnaSeq test

Couples experiencing recurrent miscarriages that lead to physical and emotional stress can choose to assess possible genetic causes of recurrent miscarriages through pre-conception genetic testing. If successful, this information can help your physicians guide fertility treatment to maximize your chances of having a healthy baby.
Miscarriages can happen for variety of reasons:

  • disruption of blood supply to embryo due to abnormal blood clotting;
  • autoimmune response due to underlying inflammatory condition;
  • genetic defects that abort the normal developmental program.

The latter category includes random mutations as well as variations that are passed on from the parents. Analyses of tissues in spontaneous abortions identify gross chromosomal abnormalities that are incompatible with life only in 10-50% of the cases. Higher resolution analysis by genome sequencing could identify point mutations underlying embryonic developmental arrest.

PregnaSeq is a high resolution genetic analysis, called exome sequencing, of you and your partner’s DNA to identify potential genetic variations that may explain recurrent miscarriage. Also, the knowledge of specific genetic variations carried by prospective parents can help select viable embryos through targeted pre-implantation genetic screening.

We will sequence the ‘protein-coding’ region in your genome and analyze the coding regions of about 20,000 genes. GeneYouIn will assess which genetic variations may cause infertility, recurrent pregnancy loss as well as predisposition to common diseases which may increase the risk of miscarriages.

Please note that the proposed genetic analysis might reveal you and your partner’s inherited predisposition to cancer and other significant illnesses that we will have to disclose to you. We will also report disease carrier status that may help you to reduce the risk of passing a genetic disease to your progeny.

Although knowledge of genetic risk does not affect the chances of developing potential illness, this information may help you to mitigate future risks of illness through personalized treatment strategies, but may also cause temporary emotional distress. Please note that your genetic information may also impact your family members who may share the same risks. If you do not wish to learn about your inherited risk predispositions, please refrain from using PregnaSeq testing.

Following genome analysis of you and your partner’s DNA, your physicians and the GeneYouIn team will identify mutations which may confer risk for pregnancy loss and discuss the results. Please note that the analysis might come to the conclusion that substitution of donor egg or donor sperm may be required to substantially reduce the risk of miscarriage. Alternatively, a pre-implantation genetic screening might be required to select viable embryos for the next attempt. You and your physicians will have to discuss your preferred treatment options.

Please note that the genome sequencing technology is an investigational tool that has enabled discovery of genetic causes of multiple diseases, yet, it is new and has not been approved by Health Canada for clinical diagnostics. Specific variations of high clinical significance will be validated independently by established clinical diagnostic methods.

This exploratory genetic analysis may fail to identify the causes of miscarriages or your fertility issues and may not be helpful for your fertility treatment. You need to recognize the limitations of this approach and it may not result in a definite resolution of your problems. Even if the next attempt results in pregnancy, there is still a chance of miscarriage. The genetic analysis does not guarantee pregnancy or health of the future baby. Please discuss this study with your partner, fertility expert and other individuals.

3. Consult with us

GeneYouIn’s genetic consultants are available during regular working hours to answer any questions you may have before you decide whether one or all of our genetic testing options are the right solution for you. A complementary 30-minute phone consultation is also included in all test packages, so we can explain your test results. We may request additional health information in order to answer any questions you may have. This may include questions about your family history and personal medical history. However, you are never required nor obligated to provide any health or other information if you choose not to do so.

The PillCheck test analyzes multiple medications based on your genetic profile. You can access your data to check any new medication that might be prescribed to you at any time through our secure web application – this service and the yearly VitaSeq re-assessments are free of charge. You will receive e-mail notifications of updates and you will be able to access your GeneYouIn account to review these updates and changes. To benefit from these services, please keep your contact information up to date and ensure that spam filters do not block our e-mails.

GeneYouIn’s PillCheck, VitaSeq and PregnaSeq services are dynamic and constantly incorporate new evidence from genetic and medical research studies. As we strive to provide you with the most up-to-date information, GeneYouIn may, from time to time, re-analyze your DNA to provide you with the latest information regarding your genome, and how it relates to old and new conditions, medications, and traits.

4. Consequences of genetic information

There are possible drawbacks related to your use of the GeneYouIn genetic testing services.
Some people may find the cheek swab uncomfortable.

People experience a variety of emotions after receiving information about their genetic predisposition to certain conditions. Some individuals may have a strong emotional reaction, particularly with respect to test results with a negative health prognosis. It may be difficult to know in advance how you may react to the results. If you have been diagnosed by a health-care professional with depression, anxiety, or other mental health disorder, we recommend that you consult with your health-care provider before proceeding with testing. In this case, or if you feel that genetic testing may cause an emotional harm to you or your family, you may choose not to proceed with testing, or you may choose to do so under the close supervision of a qualified health-care provider. By electing to proceed with testing, you acknowledge that you have either consulted with a qualified health-care provider or you are proceeding knowing the possible drawbacks and consequences of testing.

Some people worry that their genetic information could be used to discriminate against them in regards to their job, or their health, or life insurance. The Genetic Information Nondiscrimination Act (known as GINA) was signed into law in May 2008 in the United Sates. This legislation offers federal protection against discrimination based on an individual’s genetic information in health insurance and employment settings. While there are different laws in place across the globe that prevent companies from discriminating against people based on race, age, handicaps, and genetic predispositions such laws are not yet fully implemented in Canada.

Please note that GeneYouIn will not disclose your health information without your explicit consent or a legal order. Most provincial authorities have also enacted legislation intended to safeguard genetic information, but these laws vary and you should find out how these laws may affect you.

5. Secure sharing of your data

We strongly encourage you to share the results of the test with your healthcare provider in order to maximize the benefits of the test, ensure proper interpretation of test results, and if necessary, arrange for additional testing to validate our findings. Communication with your physician and/or naturopathic doctor is essential to ensure proper and informed care. Through our electronic tools, you can grant your physician or other trusted health care provider secure access to your report. If at any time you decide to withdraw your consent, you may request deletion of your records.

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