RxGenomix Informed Consent for Pharmacogenomic Testing
This Informed Consent reviews the benefits, risks and limitations of undergoing genetic testing as selected on your order form or in your account settings (“Test(s)”, as described in further detail below) provided through RxGenomix, LLC and its contractors (“RxGenomix”). It also explains how your information and sample(s) will be used in connection with the Test(s) and for other treatment, payment, and healthcare operations purposes. Throughout this Informed Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and sample is being provided for this Test, and references to “we”, “us”, and “our” refer to RxGenomix and, as appropriate in context, its affiliated clinical laboratories, bioinformatics partners and pharmacists. If you are a parent or guardian requesting a Test for a minor, “you” will refer to “your child”, as appropriate in context. In order for us to process your sample and provide you and your healthcare provider with your results, you must confirm by signing below, signing electronically or otherwise acknowledging that you have read, understood, and agree to this Informed Consent. You are not required to have the Test. Prior to signing this Informed Consent, you may wish to speak with a healthcare provider about the Test.
The RxGenomix Pharmacogenomic Test process aims to detect clinically relevant variations (called genotypes, alleles, or diplotypes) within a subset of genes that may affect how you process and respond to certain medications, subject to the factors outlined under “Limitations of the Test” below. The clinical relevance of all included genes has been informed by published evidence. The specific list of reportable variations will be available in your report. RxGenomix may, at its sole discretion, update the list of reportable variations, as the clinical science develops. If re-analysis occurs based on this, or if re-analysis reveals significant changes to reported results, then results may be updated. However, RxGenomix does not undertake any duty to update reported results unless RxGenomix has specifically agreed with you or your healthcare provider to do so.
The RxGenomix Pharmacogenomic Test and Affiliated Laboratories
RxGenomix partners with clinical testing laboratories that are accredited by the College of American Pathologists and meet the certification requirements for high complexity testing established under the Clinical Laboratory Improvement Amendments.
What We Collect and How it is Used
If you request a Test, you will be asked to provide your Personal Health Information (PHI). By way of example, PHI may include the following information:
- Information about you such as age, ethnicity, and biological sex;
- Information about your history of certain health conditions, your medication history; and
- Information about your physical and mental health, wellness, and lifestyle.
Even after you’ve received your Test results, at various times, you may be asked to provide additional PHI. The more accurate and complete information you provide to RxGenomix, the more personalized and useful the data, analytics, and health indicators that may be generated from it can be.
If another person is submitting your PHI or related information on your behalf, by signing this Informed Consent, you represent and warrant that such person is authorized to provide such information, and that all such information is accurate.
An authorized provider will review the information you submit when you request a Test, and if the provider determines that the Test is appropriate for you, the provider will order the Test for you.
You will also be asked to provide a saliva sample in accordance with RxGenomix’s collection procedures. Your sample and PHI will be transferred to one of RxGenomix’s affiliated laboratories in the USA for processing. DNA will be extracted from the submitted sample and sequenced. Sequence data includes information about genes and regions relevant to the ordered Test, as well as other regions up to and including the entire genome. Because saliva samples frequently include DNA from other sources (e.g., bacteria, food), RxGenomix may also sequence and collect information about that DNA if present. All sequence data may be used for regulatory compliance or healthcare operations and may also be de-identified and used for internal quality control, validation studies, and internal research and development purposes. Analysis and reporting on genes and regions beyond those relevant to the ordered Test will not occur unless you consent to future products or services, or unless you opt into third-party research and RxGenomix’s research database described below.
Upon successful completion of the Test, you hereby request that your Test results, PHI, and other information you provide about yourself to RxGenomix be made available to you and your ordering provider and authorize RxGenomix to transmit such information to you and your ordering provider. Results and information may be formatted, organized, and transferred in various electronic formats, as requested by your provider. If your ordering provider is part of a clinic or health system, your results and information may also be made available or distributed throughout such clinic or health system (including for example, through an electronic medical records system), as part of that clinic or health system’s treatment, payment, and healthcare operations. Further, RxGenomix may provide your clinic or health system with other data it has collected or sequenced, and related analyses, for its use for treatment, billing, healthcare operations, data analytics, research or other purposes for which they have agreed to comply with applicable laws. You can consult with your provider, clinic, or health system about their disclosure and use of such information.
Benefits of the Test
Your results may show that the genes we analyzed and reported on may affect how you process or respond to certain medications. Knowing this information may help your provider make more informed prescribing or dosing decisions.
Risks of the Test
The Test is a genetic test that may cause you to discover sensitive information about your health, specifically related to your ability to metabolize certain medications. The US Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits discrimination on the basis of genetic information with respect to health insurance and employment. However, certain exceptions apply, and we encourage you to review GINA and related laws and regulations. There are currently no US federal laws that prohibit discrimination in life insurance, disability insurance or long-term care insurance, which may be governed by state law. If you live outside of the US, depending on your country of residence, there may be significant differences in the laws and regulations governing the use and disclosure of genetic information, or there may not yet be any laws or regulations governing the use or disclosure of genetic information. Nothing in this Informed Consent constitutes legal advice, and you should consult with your own lawyer if you have questions about your legal rights relating to your genetic information.
Limitations of the Test
Your Test is intended to detect variants within a specified reportable range of selected genes known to detect gene alleles and variants (within a specified reportable range) known to impact your ability to process and respond to medications. However, this Test may not detect every variant or allele that may affect how any person, including you, processes or responds to medications.
Analysis of results is based on currently available information in the medical literature and scientific databases, as well as laboratory informatics and algorithms that may be subject to change. Such analysis requires the exercise of professional judgment and is not an exact science. New information may replace or add to the information that was used to analyze your results. Based on this new information and/or modifications to laboratory informatics and algorithms, you understand and agree that RxGenomix may, at its sole discretion, amend or modify your Test report. This may result in a change in your risk assessment; the reclassification of a variant; a change or update to a previously reported pharmacogenomic allele; or a reclassification of a reported diplotype. RxGenomix will attempt to notify you of any material amendments or modifications. You hereby irrevocably waive any and all claims against RxGenomix for any amendment or modification of the Test report in accordance with RxGenomix’s standard operating procedures. Again, RxGenomix does not undertake any duty to update reported results unless RxGenomix has specifically agreed with you or your healthcare provider to do so.
Your Test is intended to establish if any of the analyzed alleles are present. This test does not detect all possible variations in the analyzed genes. A “normal metabolizer” result does not guarantee that the gene functions normally, but only that there is no conclusive evidence suggesting that any of the tested non-normal alleles were present. The activity of the tested genes is just one of the factors that influence your ability to process and respond to certain medications. Other factors include the influence of other genes, your health history, environmental factors, and other medications you may be taking. Different genes and factors may interact in ways that are not completely understood.
RxGenomix and its affiliated laboratories implement several safeguards to avoid technical errors, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means that genetic variation was reported which is not in fact present. A false negative result means the Test failed to identify a genetic variation that is in fact present and within the reportable range.
Other sources of error, while rare, include sample mix-up, poor sample quality or contamination, inherent DNA sequence properties, and technical errors in the laboratory. In addition, if you have certain rare biological conditions or have had certain bone marrow, kidney, liver or heart transplants, transfusions, or hematologic malignancies, these conditions may limit the accuracy or relevance of the results or prevent the Test from being completed. RxGenomix expressly disclaims any liability for the inaccuracy of Test results resulting from such conditions or the failure to provide accurate, correct or complete PHI (including your medication history), and you expressly waive any claims against RxGenomix with respect thereto.
For genes having pharmacogenomic relevance, your results may reveal that you may process or respond to certain medications more or less effectively than the average person. Genetics is only one of the factors influencing medication effectiveness. Your provider can consider this information along with other factors, such as the influence of other genes, your health history, environmental factors, and other medications, in determining how best to provide and manage your medications. Always consult with a provider before stopping or making any other medication changes. Changing medications or dosages on your own could be harmful to your health.
You should consult with your provider and an RxGenomix pharmacist to ensure you understand your Test results and how they may inform your personalized healthcare plan going forward. By signing this Informed Consent, you understand and agree that your results must be considered in the context of broader medical management by a provider, and that you should not make medical decisions without consulting a provider. RxGenomix does not provide medical services such as diagnosis and/or treatment.
Privacy and Data Security
Your privacy is important to RxGenomix. Details about RxGenomix’s policies governing patient privacy and health information, including patient rights regarding such information, can be found at RxGenomix.com/privacy, or will be made available to you upon request by emailing support@RxGenomix.com. RxGenomix complies with the applicable requirements of the US Health Insurance Portability and Accountability Act of 1996 (as amended) and, as applicable, the EU General Data Protection Regulation (GDPR). RxGenomix implements certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your protected information. RxGenomix cannot, however, guarantee the security of any information you transmit to RxGenomix or store on the RxGenomix website, and you do so at your own risk. You agree that RxGenomix is not liable for the unauthorized release of your information, unless such release was the result of gross negligence or willful misconduct on the part of RxGenomix. In the event of a data breach, we intend to comply with all applicable reporting requirements. If you are domiciled outside of the US, you should consult with your physician because genetic testing may be subject to specific regulatory constraints, or be prohibited, in certain countries. By agreeing to this Informed Consent you agree that the laws and regulations of the US regarding collection, use, processing, and storage of patient information shall govern RxGenomix’s performance of the Test and handling of your sample and information, even if they may differ from those of your country of residence. You further agree that by providing your sample, you are not violating any export ban or other legal restriction in your country.
Use of Your Information and Samples After the Test Is Complete
- Upon completion of the Test, you are requesting that your results be made available to you and your provider as specified in your account or order form. By agreeing to this Informed Consent, you also agree that your genetic information, PHI, Test results, and analysis of this information can be shared with your ordering provider, and with any healthcare provider that you or your ordering provider designates. You also agree that RxGenomix may communicate with you about your collection kit, order, results, account details, and other Test logistics and procedures.
- RxGenomix and its affiliated laboratories store your genetic sequencing and related data as required by applicable laws and regulations, and we may use this data to conduct subsequent testing or analysis in the event that (a) you consent to any new product or service offering; or (b) our review of medical literature and/or changes in technology indicate that such analysis is useful or necessary to confirm results provided. Such subsequent testing or analysis may also require an updated physician order.
- RxGenomix affiliated laboratories will retain the sample (saliva and/or extracted DNA) only for the maximum duration permitted under applicable law or regulation (“Retention Period”), after which point it will be destroyed. Samples from New York clients will be destroyed within 60 days after RxGenomix’s affiliated laboratory’s(ies’) receipt of the sample (or upon completion of all Tests, if later). Until such time as your sample is destroyed, RxGenomix’s affiliated laboratories may de-identify your sample and use or store it for regulatory compliance purposes, internal quality control, laboratory validation studies, and/or or internal research and development.
- If your employer has provided or paid for (in whole or in part) the Test, you acknowledge and agree that your de-identified results and PHI may be anonymized and/or aggregated and returned to your employer or its designee (e.g., plan administrator or pharmacy benefits manager) as a data analytics resource.
- If your ordering provider is part of a clinic or health system, RxGenomix may provide such clinic or health system with your results and information, other sequencing data, PHI, and related analyses, for their use for treatment, payment, healthcare operations, data analytics, research or other purposes for which your clinic or health system has agreed to comply with applicable laws. RxGenomix or your clinic or health system may request you provide a HIPAA Authorization for certain disclosures or uses.
- Data and Sample Use for Public Variant Databases, Regulatory Compliance, Internal Quality Control, Laboratory Validation Studies, Internal Research and Development, and Publications:
- By signing this consent, you acknowledge and agree that RxGenomix and its affiliated laboratories may de-identify the sequenced genetic information and aggregate this genetic information with de-identified genetic information from other clients. De-identification means that personal identifiers associated with your genetic information will be removed. The de-identified genetic variants may be submitted by RxGenomix to public variant databases such as ClinVar to advance medical research.
- You also agree that your genetic information, PHI, personal data, and results may be stored and used by RxGenomix and its affiliated laboratories for regulatory compliance purposes.
- Your genetic information, PHI, personal data, and results may also be de-identified, stored and used for internal quality control, validation studies, internal research and development, and in publications authored by RxGenomix and its affiliated laboratories, either on its own or in collaboration with academic or commercial third parties.
Optional Use of Your Information and Samples Consent
I confirm that I have read (or have had read to me) all of the information in this Informed Consent document, and I understand what it says. I have had the opportunity to ask any questions I may have about the RxGenomix Test and related issues, and all of my questions have been answered to my satisfaction. I freely and voluntarily consent to undergo this testing, and I specifically represent, acknowledge and consent to the following:
- The sample being provided is mine and I am at least 18 years of age, or if consenting for someone else, I have the legal authority to consent for such person whose sample is being provided. If the sample being provided is from someone under the age of 18, I represent that I am the parent or legal guardian of the person being tested.
- This Test is not intended to diagnose whether I have (or will in the future get) any particular disorder. It is intended to tell me about how my genetics may affect how my body processes certain medications.
- The reported results and information are intended solely for use by a provider and do not constitute medical advice by RxGenomix. I should not make any medical decisions or medication changes based on these results without speaking to my provider first. My provider remains ultimately responsible for all diagnosis and treatment decisions.
- My doctor and I can speak with RxGenomix’s clinical pharmacists at no additional charge.
- My sample will be sequenced for the genes and regions identified in the Test(s) selected. My genetic information, PHI, personal data and results may be stored and used by RxGenomix and its affiliated laboratories for regulatory compliance and healthcare operations purposes.
- If my ordering provider is part of a clinic or health system, I consent to RxGenomix providing such clinic or health system with my results and information, other sequencing data, PHI, and related analyses, for such clinic or health system’s treatment, payment, and healthcare operations.
- My sample and all my related personal information will be transferred to a RxGenomix affiliated laboratory in the United States for analysis, use, processing, and storage, and will be subject to the laws, rules, and regulations of the United States.
- All saliva samples (including those received from New York clients) will be destroyed after the end of the applicable Retention Period.
For patients domiciled outside the US: Clients who are domiciled outside of the United States in certain jurisdictions may have the option of requesting that their personal information be deleted at any time from our active databases, subject to the applicable laws and regulations of such jurisdiction. Please note that deletion of this information prior to completion of the Test will result in a cancellation of the Test, and no results will be provided to you or your healthcare provider. Although we can delete your personal information from our active databases, some or all of your personal information will remain archived in back-ups for compliance with legal, regulatory, and other requirements. Information that has already been de-identified, anonymized, and/or aggregated may not be retrievable or traced back for destruction, deletion, or amendment. If you choose to have your personal information deleted from our active databases, please contact us at support@RxGenomix.com