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Terms & Conditions for Genome Scanning Provided by TruGenetics™

Introduction
Before you can proceed to obtain a genome scan from TruGenetics™, and use the services provided by TruGenetics™, we would like you to understand the potential consequences of knowing the genetic information that you will obtain, how your genetic information will be protected by TruGenetics™, Inc. and how your genetic information might be used by you and TruGenetics™, Inc. in the future.

The TruGenetics Process
There are four major steps to this process. First, you must read through this document and register for a unique TruGenetics™ account. Second, you will be asked to fill out a detailed online questionnaire that will help us gather important information that will not only help us provide you with a personalized interpretation of your genetic information, but also help us conduct genetic research. This questionnaire will ask you about personal information, including that related to traits and health history. Third, after this questionnaire is completed, we will send you a sputum collection kit through the mail, labeled with your unique TruGenetics™ identifier number. Once we receive your sputum through the mail, we will extract DNA from your sputum and perform a genome scan using state of the art technology. Finally, when your genetic information is ready for you, we will notify you to sign in to your unique TruGenetics™ account, within which you will be able to privately review and explore your genetic information.

The Genetic Information
The genetic information we will provide you will be in the form of genotypes for over 500,000 SNPs, genetic markers, in your genome. This represents a small percentage of the overall genetic information contained in your genome and does not completely represent your genome. However, scientists have figured out how to efficiently select these SNPs so that these genotypes can provide significant amount of information about your genome. Many genetic studies have been able to use SNPs to identify regions of the genome that are associated with the development of a trait or disease.

Interpretation of the genetic information we provide you is not complete. The field of genetic research is advancing rapidly. What we know about genetics today will likely be different in the near future. As mentioned above, only a very small percentage of the genetic information we will provide you is known to be associated with certain traits or diseases. As part of your willingness to participate in our discovery effort described below, we will provide you with updates of the latest genetic discoveries based upon your genome scan. We may also periodically ask you to complete additional questionnaires to help us interpret your genetic information in light of new genetic discoveries.

The genome scanning process is excellent, but not perfect. All of our genotyping will be performed in a CLIA certified laboratory using the most strict criteria for genotyping accuracy. Our process ensures that on average, 99% of the data we obtain from a genome scan will be accurate and usable. However, this means that 1% of the time, or approximately 5,000 genotypes if 500,000 SNPs are evaluated, will not be useable. Therefore, it is possible we may not be able to provide your genotype for some of the listed traits and diseases.

The genetic information available to you is not intended for personal disease risk prediction. This is because the current state of genetic research indicates that while the genotypes that we provide have been found to be associated with development of certain traits or diseases, not enough is known to accurately predict an individual’s risk based upon their genotype.

The genetic information provided to you does not provide a medical diagnosis. Although we will identify over 500,000 genotypes for you, only a very small percentage of them have been found to be associated with certain traits or diseases. Based upon the current state of scientific knowledge, these genotypes cannot accurately tell you whether you have a trait or disease. Although these genotypes have been found to be associated with higher odds of having a trait or disease, there are many other variables from the environment that you live in that can also influences these odds.

The genetic information available to you is not a medical test and is not intended for medical decision-making, including family planning decisions. The genetic information that we will provide you should be treated as informal information about your genome for your own personal use. If you are interested in making medical decisions or significant lifestyle changes based upon genetic testing, you should discuss this with your healthcare provider and if appropriate, obtain a certified genetic test through your healthcare provider.

Risks
You may not anticipate the effect of knowing some types of genetic information. As part of this process, you will have access to genetic information that may lead to an emotional response or trouble you. For instance, you may learn some unanticipated information about yourself or a family member. This may have social, legal, or economic implications that you cannot anticipate at this time. Although we will give you the opportunity to review all of your genetic information, you will also be able to choose to not review certain genetic information until you are ready. We will also offer genetic counseling services that can help you better understand the implications of the genetic information.

You should be careful about sharing your genetic information. Although genetic data is not widely used by businesses and insurance companies at this time, this may change in the future and you should be very careful about who you share your genetic information with. You should also be careful about sharing of your genetic information with friends and family members. This may lead to conflicts or evoke strong emotional reactions and result in unforeseen consequences that may not be in your best interest.

Interpretation of your genetic information may change. As indicated above, the genetic field is moving rapidly, with new discoveries every day. It is possible that our understanding of certain genetic information may change in the future, and the interpretation of the genetic information today may be different in the future. This is why we do not recommend that any medical actions are taken based upon the information we provide. TruGenetics will do its best to provide updated genetic information to all of its users. However, we cannot guarantee that our interpretation of the genetic information will be the most up-to-date at all times.

Privacy & Protection
Your account information, questionnaire responses, and genetic information will be kept in a secured protected database. Upon registering with TruGenetics™, you will be assigned a unique identifier. Any time your information is used, we will only refer to this unique identifier. The only way to trace this information to you is through the unique TruGenetics™ identifier number, which will only be accessible by the database managers at TruGenetics™.

All of your genetic information are encrypted and secured for your protection. We use the same encryption as Banks and other financial companies. So, the information will be maximally protected from unauthorized access.

Access to your information will be limited. Your contact and payment information will not be disclosed to anyone outside of TruGenetics. However, there may be extremes circumstances under which we will be legally required to release this information. If this should occur, we will do our best to notify you before providing your information to outside parties, unless prohibited by law.

You may authorize the release of your genetic information. In the event that you are interested in releasing your genetic information to another party, such as your physician, we will require that you provide this authorization in writing to document your approval of release of genetic information. As part of this authorization, we will require you answer questions that only you will know the answers to. These questions and answers will be established at the time of your registration. Once this documentation is provided, we will facilitate the transfer of your information to the indicated party. A fee may be required for this transfer.

The Genetic Information Nondiscrimination Act (GINA). The President of the United States signed GINA into law on May 21, 2008. This Act prohibits discrimination on the basis of genetic information with respect to health insurance and employment. This law prohibits American insurance companies and health plans (including both group and individual insurers, as well as federally-regulated plans) from evaluating your genetic information before you are considered for healthcare coverage, request or require that you undergo genetic testing before being considered for healthcare coverage, deny healthcare coverage based upon genetic information, or use genetic information to determine the extent or cost of healthcare coverage. This bill also prevents any U.S. employer from using genetic information to determine who they hire or the salary, request or require that you undergo genetic testing before being hired, or disclose your genetic information except under specific and specially controlled circumstances.

Research
Your questionnaire responses and genetic information will be used for genetic research. One of the main goals of TruGenetics™ is to develop a unique research database for conducting genetic studies. Your decision to use TruGenetics’™ services indicates that you are willing to contribute your questionnaire responses and genetic information to the TruGenetics™ research database. This research database will be free of any information that can be used to trace this data to you. All of the data in the research database will be anonymized and analyzed in aggregate (as a group) so that no single individual can be identified through the research database. TruGenetics™ may conduct this research, or may partner with another organization, including non-profit and commercial entities, to conduct research. TruGenetics™ may charge a fee for conducting research using this database. This research may lead to publications that reveal the findings. These publications will not contain any information that can be used to identify you.

You will not benefit directly from contributing your information to the research database. However, important discoveries might be made through this research, and this might significantly help other people. If these discoveries are validated and accepted by the scientific community, we will provide you with this information as it pertains to your genes. This research may also lead to the development of a commercial product. You will not receive any payments if this occurs.

Withdrawal
You have the right to remove your account and all of your genetic information from TruGenetics™ at any time. This must be done with a written request documenting this intention. Within thirty days of receiving this documentation, we will remove all of your contact and payment information, your questionnaire responses, and your genetic information from our records. This information will no longer be retrievable by you or anyone else in the future. This information will not be included in any future research. If using your information was included in research \ conducted or initiated prior to receiving this documentation, that research will not be altered.

In summary, by participating in this process, you are agreeing to the following:

  • You are eighteen years of age or older
  • You are guaranteeing that the saliva specimen you are providing is from you, and no one else.
  • You are not from an insurance company or an employer trying to obtain information about another person.
  • You give TruGenetics permission to manage and use your information according to the terms as described above.
  • You yourself will not copy, modify, create a derivative work of, reverse engineer, decompile, or otherwise attempt to extract the source code of TruGenetics’ proprietary software or any part there of.
  • You agree that this Consent and Legal Agreement will be governed exclusively by the laws of the State of Washington, and that any disputes arising from this Consent and Legal Agreement will be resolved by binding arbitration in Seattle, Washington under the Rules of the American Arbitration Association.
  • You will hold harmless TruGenetics, its employees, contractors, successors, and assigns from any liability arising out of the use or disclosure of any information that is obtained from genotyping your saliva sample, that is disclosed to you consistent with our privacy statement and resulting from any third-party add-ons to tools we provide.
  • You understand that your genetic or other contributed personal information may be provided to third parties-whether individuals to whom you facilitate access, intentionally or inadvertently, or to third parties for diagnostic or other purposes-you agree to hold harmless TruGenetics, its employees, contractors, successors, and assigns from any and all liability arising from such disclosure or use of your genetic or other contributed personal data. The terms of service above provides a complete understanding of terms applicable to our services.

 

 
 
 
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