informed consent
Dear User,
Thank you for your interest in our test!
Before you proceed, it is of the utmost importance that you carefully read and understand this Informed Personal Consent. By agreeing to undergo our test, you acknowledge that you have carefully read and understood all provided information and agree that this consent serves as the equivalent of written and signed consent.
Purpose of the Test
With our commercial DTC genetic test, we will test and analyze your DNA. By undergoing our test, you agree to provide us with a saliva sample that we will use to extract DNA, and you guarantee that the submitted sample belongs to you. If you are consenting on behalf of someone else (for whom you possess legal authorization), you guarantee that the submitted sample belongs to them, and you are their legally authorized representative. We will extract DNA from your sample and use microarray technology to test for specific genetic variants that:
- May determine your carrier status for certain rare diseases
- May increase your risk of common diseases
- May affect drug response
- May indicate your ancestry
- May be related to personal traits
Non-diagnostic Nature of DTC Genetic Tests
By undergoing our test, you acknowledge and understand the following:
- The results in the rare and common diseases sections are solely for educational and informational purposes
- The test is not diagnostic and should not be used to diagnose any diseases
- The test should not be used to explain your current health state or to make any medical, clinical, or healthcare decisions
- The test should not be used as a substitute for regular medical check-ups, medical screenings, medical tests, and medical consultations with your healthcare provider
- Your healthcare provider should refer you to an independent genetic test in a clinical setting to confirm any findings
- The test does not analyze all possible genetic variants that may affect disease risk; it detects only specific genetic variants predetermined with the test specifications
- Other genetic variants not analyzed with this test, as well as other extrinsic factors such as lifestyle, medical history, and the environment, may also affect disease risk
- Genetic testing cannot predict with certainty whether you will develop a disease
- The pharmacogenetics results are solely for educational and informational purposes
- The pharmacogenetic test results should not be used to initiate, discontinue, or alter any existing medication regimen or treatment plan
- Your healthcare provider should refer you to an independent genetic test in a clinical setting to confirm any pharmacogenetics findings
- The test does not analyze all possible genetic variants that may affect drug metabolism; it detects only specific genetic variants predetermined with the test specifications
- Other extrinsic factors, such as other medications, lifestyle, medical history, and the environment, can also affect drug response.
Technical and Other Limitations
By undergoing our test, you acknowledge and understand the following:
- The test can detect only specific and predefined genetic variants; other variants not included in the test specifications will not be detected
- Sometimes (rarely), we must repeat the whole process (at our expense) due to inadequate sample quality, insufficient sample concentration, or other reasons, so you may be asked to provide us with a new sample
- Due to testing and technical shortcomings, sometimes the analysis cannot be performed, and certain variants cannot be detected
- The result interpretations are based on research and databases available at the time of the creation of the report; these interpretations may change as new information becomes available in the databases
- No test is 100% accurate, and there is a risk of false positive or false negative results that may originate from various sources. Read the technical specifications of the test.
Genetic Counseling and Other Services
By undergoing our test, you acknowledge and understand the following:
- As a commercial DTC genetic testing service and a private company, we cannot provide you with genetic consultations, healthcare support, or medical assistance
- We will not present the results to you in person or in the presence of a doctor, genetic counselor, or another healthcare professional
- The test may have different implications for you or your family, but as a DTC genetic testing service and a private company, we cannot offer support regarding these implications
- You hold responsibility for any outcomes that may occur if you share the information and data from your test results with others.
Sample Storage and Retention
By undergoing our test, you acknowledge and understand the following:
- We will use your sample only for the specific DNA microarray genotyping test that you are consenting to; we will not use your sample for any other purposes, such as additional clinical studies or scientific research
- We are not a genetic data storage facility (DNA bank) and are not able to save your sample for future testing or use.
Data Privacy and Confidentiality
By undergoing our test, you acknowledge and understand the following:
- Your data will be collected and processed following the Privacy Policy. Read our Privacy Policy.
Changes to Policies
By undergoing our test, you acknowledge and understand the following:
- Our policies, terms, services, and practices may change over time; any changes will be effective immediately, and we will notify you through our website.
Voluntary Nature of Testing
By undergoing our test, you acknowledge and understand the following:
- The decision to undergo genetic testing with Nuclein Health is completely voluntary and independent. By agreeing to undergo our testing, you acknowledge that you have carefully read and understood all provided information in this Informed Personal Consent. You have the right to withdraw your consent before the testing is performed. Feel free to contact us with any questions you might have.
User declaration
You declare that you have read, understood, and agreed to all the terms and conditions outlined in the informed consent provided. You voluntarily choose to undergo our genetic test and acknowledge the limitations and implications associated with the results. You understand that this consent serves as the equivalent of written and signed consent, and you are responsible for all decisions made based on the information provided by Nuclein Health.
* Last update: 25.09.2023