Geneticure Terms of Service
- Ordering the Test; Medical Advice
If you are an individual requesting the Test for yourself, Geneticure recommends that you speak with your physician or other qualified healthcare provider regarding any questions you may have about the treatment, mitigation, or prevention of any genetic condition, or how your genes may impact how you process or respond to certain medications. Geneticure’s clinical Tests can only be ordered by an authorized healthcare provider. You understand and agree that the Test is an informational test and not a diagnostic test, and that the Results are intended solely for use by a healthcare provider. You should not make medical decisions or changes to medications or dosages without consulting a healthcare provider. Geneticure does not provide medical services, diagnosis, treatment, or advice. Nothing contained in the Results or made available through the Service(s) (e.g., consults with Geneticure’s genetic counselors or clinical pharmacists) is intended to constitute medical advice, the practice of medicine, or the provision of medical care or to otherwise create a patient-healthcare provider relationship between Geneticure and you. The information provided by the Test or through the Site or Service is not a substitute for the advice of a personal physician or other qualified healthcare provider who can consider your Results in the broader context of medical management.
- Healthcare Providers Acting on Behalf of Their Patients
If you are a healthcare provider obtaining a patient sample or submitting an order for your patient, you represent and warrant that: (i) you are authorized in your jurisdiction to order the Test on behalf of your patient; (ii) you have advised your patient of the benefits, risks, capabilities, and limitations of the Test(s) and Service; (iii) you have obtained consent from your patient to share patient health information with Geneticure, as required under the Health Insurance Portability and Accountability Act of 1996, as amended, and any other applicable data privacy requirements; (iv) you have confirmed that your patient has signed or will sign the Informed Consent, either in paper form or upon activating their Test Kit through the Site; and (v) you will notify Geneticure of any changes in patient information and consent status (e.g., changes in consent regarding sample storage).
- Accounts and Activation
If you are an individual providing a biological sample yourself, please create an account and activate your Test Kit to associate your sample with your account. If you are a healthcare provider ordering a clinical Test or obtaining a patient sample and providing it to Geneticure on your patient’s behalf, you must also create an account and activate the kit on behalf of your patient. During the account creation process, you may be required to provide us with some information about yourself (such as your email address or other contact information), or if you are a healthcare provider, about the individual for whom the Test is intended to be used and your NPI number. You agree that the information you provide to us is accurate and that you will keep it accurate and up-to-date. Individuals setting up an account for themselves will be asked to create a password. You are solely responsible for maintaining the confidentiality of your account and password. We will never request your password in a phone call, email, or chat. However, when you contact our customer support, genetic counselors, or clinical pharmacists, we may ask you to confirm certain PII (as that term is defined below) to verify your identity and help keep your account information secure. Please note that we cannot guarantee the security or privacy of information you send to us via the internet or wireless connection (for example, via email messages) until that communication reaches our information systems. You agree to accept responsibility for all activities that occur under your account or under your control. You will not permit or enable someone else to access the Services using your account username, password, or other security information. If you access your account from a public or shared computer, you should exercise caution to ensure your account information is not saved or retrievable on the shared device. You may not impersonate someone else or provide an email address other than your own. If you have reason to believe that your account or information you shared with us is not secure, then you should promptly change your login information and notify us at firstname.lastname@example.org.
Geneticure reserves the right, in its sole discretion, to terminate your account at any time, and to prohibit your access to the Site and/or the Services, for any reason or no reason and without notice to you. If Geneticure discovers that you are using the Services for non-personal or commercial purposes, or that you have provided false information related to a Test, for example, by misrepresenting information you share with it or providing another person’s sample and not correctly identifying the source of the sample, Geneticure may immediately terminate your account. Any unauthorized use of the Site and/or the Service can lead to your prohibition from the Site and potential civil and/or criminal prosecution.
- Additional Service Terms
If you are a patient and order directly through us or through a retailer (such as Amazon.com), we work with an independent provider network, PWNHealth, LLC (www.pwnhealth.com), to review health history and test orders to ensure our customers are receiving the best test for their health concerns. PWNHealth also provides genetic counseling if desired by user. The cost of the PWNHealth service is approximately $40 and is included in the price of the Test. PWNHealth is an outside, independent network of healthcare providers. Health professionals from PWNHealth review test requests, identify potential drug-drug interactions, and offer consultation throughout the testing and reporting process.
- Information About Yourself and Your Relatives
To receive the Services, you must provide a DNA sample in accordance with Geneticure’s collection procedures. Your sample and PII will be transferred to Geneticure’s laboratory, or contracted laboratory, in Minnesota and/or Arizona, USA, for processing. DNA will be extracted from the submitted sample and genotyped. Genotyped 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 DNA samples frequently include DNA from other sources (e.g., bacteria, food), Geneticure may also sequence and collect information about this DNA if present. All genotyped data may be used for regulatory compliance, and de-identified 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. Only high-quality variant calls within the reportable range of an ordered Test will be considered part of the designated record set. Data that has not been analyzed and reported on will not be returned. Your Sample is destroyed following analysis and your DNA is not retained for any further testing.
- United States Data Privacy Regulations; International Clients
Clients who live outside of the US in certain jurisdictions may have the option of requesting that their personal information be accessed, updated, and/or removed at any time from our active databases, subject to the applicable laws and regulations of such jurisdictions. Such clients may also have the right to object to Geneticure’s processing of their personal information and/or request that Geneticure provide their personal information to another third party. Geneticure may require that such request be provided in writing subject to applicable laws and regulations with respect to transfer of medical information. If you would like to access, update, object to processing, request provision to a third party, and/or request removal from Geneticure’s active databases of your personal information, please contact email@example.com. Any such requests will be honored within one month. If you believe Geneticure’s processing of your personal information is inappropriate, you have the right to lodge a complaint with a supervisory authority or contact Geneticure’s Privacy Officer at privacy@Geneticure.com.
- Self-Pay Payment, Refunds, and Test Kit Replacements
You may be required to pay a fee to receive the Services. All fees are in US Dollars, and all payments will be processed by a bank in the United States. If you pay with a credit or debit card, Geneticure may seek pre-authorization of your account prior to your purchase to verify that the account is valid and has the necessary funds or credit available to cover the fees. We may also engage third parties to assist us with billing and collection efforts. The purchase and sale of the Services shall be deemed to occur in Minnesota, US.
Geneticure’s clinical Tests are physician-ordered. In the event that your ordering physician decides that the requested testing is not appropriate for you, you will receive a full refund. If you decide that you no longer want the Services, please contact us immediately. If you have selected the self-pay option, we will be unable to process a refund if more than 30 days has passed since the Test was purchased, or if our lab has received your sample. If the Services can be refunded, you will receive a refund on the purchasing card, if applicable, less shipping and handling fees and a $25 cancellation fee to cover the cost of the Test Kit if the Test Kit has already been shipped to you.
Please return your DNA sample as soon as possible. Your sample must be received before the expiration date of the DNA collection kit. Your failure to timely provide a sample may result in the expiration of the Test Kit or any of its components. In such case, we would require a new sample for processing, and you may incur a replacement kit fee, plus shipping and handling fees.
On rare occasions, Geneticure may be unable to process either of your cheek swab samples, either because of an issue with the samples you submitted or due to an issue at our lab. If we cannot process your first sample (sample A), we will first attempt to process your second sample (sample B) and then any additional sample from your collection kit that we may have, if a sufficient amount is available, at no charge to you. If we are still unable to process your sample, we will send you another Test Kit (at no charge to you) so that you may submit another sample for our lab to process. If your second set of samples cannot be processed, please contact firstname.lastname@example.org to discuss your options.
If you require a replacement kit for any other reason, please contact email@example.com to receive assistance regarding a replacement kit, and to determine whether replacement fees apply given your particular situation.
- Insurance Coverage
Geneticure does not support insurance coverage at this time. You may independently submit a claim with your insurance company if desired. Geneticure makes no representations on your ability of receiving reimbursement for the test.
- Promotional Codes and Offers
From time to time, Geneticure may, at its sole discretion, make available promotional offers that may only be available to certain qualifying recipients (each, a “Promotional Offer”). Such Promotional Offers are only available to US residents and are void where prohibited. Unless otherwise expressly stated by Geneticure, Promotional Offers may not be combined and may not be resold, forwarded or otherwise transferred to any third party other than the intended recipient, and may not be applied to Services or Tests paid for by insurance (private or government reimbursed). Geneticure reserves the right to modify or discontinue Promotional Offers at any time, or to deny Promotional Offers used in breach of the Terms. If a Promotional Offer is provided to a recipient who is not eligible to receive or use a Test or Test Kit, the Promotional Offer will be null and void. Geneticure is not responsible if any Promotional Offer is lost, stolen, or destroyed, or if a Promotional Offer is used without the intended recipient’s permission. Geneticure also reserves the right to void Promotional Offers and close customer accounts if it suspects that a Promotional Offer is obtained, used, or redeemed fraudulently, unlawfully, or otherwise in violation of the Terms, or any applicable law, rule, or regulation.
IN THE EVENT A PROMOTIONAL OFFER IS NON-FUNCTIONAL, YOUR SOLE REMEDY, AND GENETICURE’S SOLE LIABILITY, WILL BE THE REPLACEMENT OF THAT PROMOTIONAL OFFER. IN NO EVENT WILL GENETICURE BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF OR RELATING TO YOUR USE OF A PROMOTIONAL OFFER, OR YOUR INABILITY TO USE A PROMOTIONAL OFFER, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE OR ANY OTHER LEGAL THEORY, WHETHER OR NOT GENETICURE HAS BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGE.
When you redeem a Promotional Offer, you agree that the laws of the State of Minnesota, without regard to principles of conflict of laws, will govern these Terms and any dispute that may arise between you and Geneticure related to your use or receipt of a Promotional Offer. Geneticure reserves the right to end any Promotional Offer program at any time at its sole discretion. Promotional Offers are not eligible for a refund. Promotional Offers shall expire at the conclusion of the promotional period associated with such Promotional Offer. If no such period is specified, then such Promotional Offer shall expire twelve (12) months after its first offering or availability.
- Limited Right to Use; Ownership; Proprietary Rights
The Service is owned and operated by Geneticure. The visual interfaces, graphics, design, compilation, information, data, computer code (including source code or object code), bioinformatics pipeline, Test Kit, and all other elements of the Service (“Proprietary Materials”) provided by Geneticure are protected by all relevant intellectual property and proprietary rights and applicable laws. Test Kits may not be resold, distributed, transferred, or used for any purpose other than for the performance of the Test(s), without the express prior written permission of Geneticure. Geneticure reserves the right to reject and/or deny Tests on any samples submitted using Test Kits that are in breach of these Terms of Service. All Proprietary Materials contained in the Service are the property of Geneticure or Geneticure’s third-party licensors. Except as expressly authorized by Geneticure, you may not make use of the Proprietary Materials, and reverse engineering of the Proprietary Materials is strictly prohibited. Geneticure reserves all rights to the Proprietary Materials not granted expressly in these Terms.
Geneticure grants you a limited non-exclusive right and license to access and use the Site for personal, non-commercial purposes. This license does not include and strictly prohibits: (i) any derivative use of the Site or its contents; and (ii) any use of data mining, robots, or similar data gathering and extraction tools. The Site, including its operation, interface, and contents, are covered by US copyright laws and international laws and treaties, and may not be reproduced, duplicated, copied, sold, resold, visited, or otherwise exploited for any commercial purpose without the express prior written consent of Geneticure. This includes, without limitation, a prohibition against (a) publishing any logo or other proprietary graphic or trademark belonging to Geneticure or any of its subsidiaries, affiliates, or other partners without our written consent, and (b) using any Geneticure content including from Geneticure’s Site or Result reports (or any portions thereof) for non-personal or commercial use without our written consent.
If you provide us with any suggestions, recommendations, or other feedback regarding the Services (“Feedback”), you agree that Geneticure may use such Feedback in any way and for any purpose, without compensation or acknowledgment.
You agree that you will be responsible for your use of the Site and the Service, and you agree to defend, indemnify and hold harmless Geneticure and its officers, directors, employees, consultants, affiliates, subsidiaries, and agents (collectively, the “Geneticure Entities”) from and against any and all claims, liabilities, damages, losses, and expenses, including reasonable attorneys’ fees and costs, arising out of or in any way connected with: (i) your access to, use of, or alleged use of the Site, Service, and Results; or (ii) your violation of these Terms or any representation, warranty, or agreements referenced herein, or any applicable law or regulation. Geneticure reserves the right, at its own expense, to assume the exclusive defense and control of any matter otherwise subject to indemnification by you (and without limiting your indemnification obligations with respect to such matter), and in such case, you agree to cooperate with Geneticure’s defense of such claim.
- Disclaimers; No Warranties
THE SERVICE AND ALL MATERIALS AND CONTENT AVAILABLE THROUGH THE SERVICE ARE PROVIDED “AS IS” AND ON AN “AS AVAILABLE” BASIS, WITHOUT WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESS OR IMPLIED. THE GENETICURE ENTITIES SPECIFICALLY (BUT WITHOUT LIMITATION) DISCLAIM ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, RELATING TO THE SERVICE AND ALL MATERIALS AND CONTENT AVAILABLE THROUGH THE SERVICE, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
YOU ACKNOWLEDGE AND AGREE THAT, AS FURTHER SPECIFIED HEREIN, GENETICURE DOES NOT PROVIDE ANY MEDICAL SERVICES OR ADVICE AND DOES NOT MAKE ANY REPRESENTATIONS, WARRANTIES, GUARANTEES OR ENDORSEMENTS REGARDING ANY MEDICAL SERVICES OR ADVICE THAT YOU MAY OBTAIN THROUGH THE SITE AND/OR THE SERVICES. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM THE SERVICE OR ANY MATERIALS OR CONTENT AVAILABLE ON OR THROUGH THE SERVICE (INCLUDING, WITHOUT LIMITATION, ANY CONSULTS WITH GENETICURE’S GENETIC COUNSELORS OR CLINICAL PHARMACISTS) WILL CREATE ANY WARRANTY REGARDING THE GENETICURE ENTITIES OR THE SERVICE THAT IS NOT EXPRESSLY STATED IN THESE TERMS. YOU ASSUME ALL RISK FOR ALL DAMAGES THAT MAY RESULT FROM YOUR USE OF OR ACCESS TO THE SERVICE. BY USING THE SERVICES, YOU FURTHER ACKNOWLEDGE AND AGREE THAT YOU WILL NOT TAKE ANY MEDICAL ACTION, OR FAIL TO TAKE ANY MEDICAL ACTION, OR CHANGE ANY OF YOUR MEDICATIONS OR DOSAGES, WITHOUT CONSULTING WITH A PHYSICIAN.
GENETICURE DOES NOT GUARANTEE CONTINUOUS, UNINTERRUPTED OR SECURE ACCESS TO ITS SERVICE OR THE SITE, AND YOU ACKNOWLEDGE THAT THE OPERATION OF THE SITE MAY BE INTERFERED WITH BY NUMEROUS FACTORS OUTSIDE OF OR WITHIN GENETICURE’S CONTROL.
SOME JURISDICTIONS MAY PROHIBIT A DISCLAIMER OF WARRANTIES AND YOU MAY HAVE OTHER RIGHTS THAT VARY FROM JURISDICTION TO JURISDICTION.
- Limitation of Liability; Waiver
IN NO EVENT WILL GENETICURE BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES ARISING OUT OF OR RELATING TO YOUR ACCESS TO OR USE OF, OR YOUR INABILITY TO ACCESS OR USE, THE SERVICE OR ANY MATERIALS OR CONTENT ON THE SITE OR OBTAINED IN CONNECTION WITH THE SERVICE, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE OR ANY OTHER LEGAL THEORY, WHETHER OR NOT THE GENETICURE ENTITIES HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGE. YOU AGREE THAT THE AGGREGATE LIABILITY OF GENETICURE TO YOU FOR ANY AND ALL CLAIMS ARISING OUT OF RELATING TO THE USE OF OR ANY INABILITY TO USE THE SITE AND/OR SERVICE (INCLUDING ANY MATERIALS OR CONTENT AVAILABLE THROUGH THE SITE AND/OR SERVICE), OR OTHERWISE UNDER THESE TERMS, WHETHER IN CONTRACT, TORT OR OTHERWISE, IS LIMITED TO THE GREATER OF (A) THE PRICE YOU PAID FOR THE SERVICE GIVING RISE TO LIABILITY, OR (B) US$50. IN JURISDICTIONS THAT DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY.
Your Results are 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. You understand and agree that Geneticure may, at its sole discretion, amend or modify your Test report based on any such changes. This may result in a change in your risk assessment; the reclassification of a variant; a change or update to a previously reported pharmacogenomic genotype or allele; or a reclassification of a reported diplotype. You hereby irrevocably waive any and all claims against Geneticure for any amendment or modification of the Test report in accordance with Geneticure’s standard operating procedures.
- Dispute Resolution and Arbitration
15.1 Generally. You agree that any and all legal action, proceeding, or disputes arising in connection with these Terms, your use of the Service and/or Site, and your acceptance and use of the Results shall be resolved by binding arbitration governed by the Commercial Dispute Resolution Procedures and the Supplementary Procedures for Consumer Related Disputes (collectively, “AAA Rules”) of the American Arbitration Association (“AAA”), as modified by these Terms, and will be administered by the AAA. Any arbitration hearings will take place at a location to be agreed upon in Olmsted County, Minnesota. Our agreement to arbitrate disputes includes but is not limited to all claims arising out of or relating to any aspect of these Terms, the Service, the Site, and the Results, whether based in contract, tort, statute, fraud, misrepresentation, or any other legal theory, and regardless of whether the claims arise during or after the termination of these Terms. If the arbitrator finds that either the substance of your claim or the relief sought is frivolous or brought for an improper purpose (as measured by the standards set forth in Federal Rule of Civil Procedure 11(b)), then the payment of all fees will be governed by the AAA Rules. In such case, you agree to reimburse Geneticure for all monies previously disbursed by it that are otherwise your obligation to pay under the AAA Rules. YOU UNDERSTAND AND AGREE THAT, BY ENTERING INTO THESE TERMS, YOU AND GENETICURE ARE EACH WAIVING THE RIGHT TO A TRIAL BY JURY OR TO PARTICIPATE IN A CLASS ACTION, AND INSTEAD ARE ACCEPTING THE USE OF ARBITRATION. You understand and agree that this agreement to arbitrate binds you and anyone else who may have a claim arising out of or related to all products and services provided to you by Geneticure, or persons employed or engaged by Geneticure.
15.2 Exceptions. Notwithstanding subsection 15.1, Geneticure and you agree that nothing herein will be deemed to waive, preclude, or otherwise limit either of our right to: (i) bring an individual action in small claims court; (ii) pursue enforcement actions through applicable federal, state or local agencies where such actions are available; (iii) seek injunctive relief in a court of law; or (iv) to file suit in a court of law to address intellectual property infringement claims.
15.3 No Class Actions. YOU AND GENETICURE AGREE THAT EACH MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR ITS INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE PROCEEDING. Further, unless both you and Geneticure agree otherwise, the arbitrator may not consolidate more than one person’s claims and may not otherwise preside over any form of a representative or class proceeding.
15.4 Modifications. In the event that Geneticure makes any future change to this arbitration provision, you may reject any such change by sending us written notice within thirty (30) days of the change in which case your account with Geneticure shall be immediately terminated and this arbitration provision as in effect immediately prior to the amendments you reject shall survive.
15.5 Enforceability. If the entirety of this Section 15 is found to be unenforceable, then the entirety of this Section 15 shall be null and void and, in such case, the parties agree that the exclusive jurisdiction and venue described in Section 17 shall govern any action arising out of or related to these Terms.
- Modification of the Terms
- Contact Information
The services hereunder are offered by Geneticure, Inc. You may contact us by emailing us at firstname.lastname@example.org.
These Terms shall continue to have full force and effect unless and until terminated by Geneticure. Geneticure may terminate, suspend, or restrict any provision of these Terms and the Service and/or Site at any time in its sole discretion and without notice to you.
- Third-Party Beneficiaries
Nothing contained in these Terms is meant or intended to confer any rights, remedies, or benefits upon any third party.
- Use of “Open Source” Software
From time-to-time, Geneticure may make use of certain “open source” software components or programs in order to provide Services to you. Where applicable, you consent to the use of any such items. You also acknowledge and agree that such components or programs were created by third parties not owned or controlled by Geneticure, and that Geneticure does not, simply by virtue of their use or integration into any Service or the Site, make any guarantees or warranties regarding their quality or authenticity.
- Electronic Signatures
By using our Site or Services you consent to transact business with Geneticure electronically.
Geneticure is committed to protecting your privacy. Details about Geneticure’s policies and procedures governing privacy can be found at www.Geneticure.com/privacy-policy, and information specific to medical information, including patient rights regarding such information as provided under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), can be found here. You may also request copies of these policies by e-mailing email@example.com.
- Our Commitment to Accessibility
Geneticure is committed to making our Site’s content accessible and user friendly to everyone. If you are having difficulty viewing or navigating the content on this Site, or notice any content, feature, or functionality that you believe is not fully accessible to people with disabilities, please call our Support team at (800) 362-8109 or email firstname.lastname@example.org with “Disabled Access” in the subject line and provide (a) a description of the specific feature you feel is not fully accessible, or (b) a suggestion for improvement. We take your feedback seriously and will consider it as we evaluate ways to accommodate all of our clients and our overall accessibility policies. Additionally, while we do not control vendors, we strongly encourage vendors of third-party digital content to provide content that is accessible and user-friendly.
Version date: November 15, 2018
Informed Consent for the Geneticure for Hypertension (High Blood Pressure) Pharmacogenomic Panel
This Informed Consent reviews the benefits, risks and limitations of undergoing genetic testing as selected on your order form or in your account settings. It also explains how your information and sample will be used in connection with the Test. Throughout this Informed Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and sample is being provided for this Test. In order for us to process your sample and provide you and your healthcare provider with your results, you must confirm by signing below 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 Geneticure for Hypertension Pharmacogenomic Panel (“Test”) aims to detect clinically relevant variants within 11 genes analyzed, subject to the Limitations of the Test section below. These variants have been associated with variability in response to anti-hypertension therapies. We use these genes to assess common genotypes with known functionality so that we may provide guidance for your blood pressure pharmacologic care based on your genetics.
The Geneticure Test and the Geneticure Laboratory
Geneticure operates under the Clinical Laboratory Improvement Amendments (CLIA), and contracts with clinical testing laboratories that are accredited by the College of American Pathologists.
What We Collect and How it is Used
If you request a Test, you will be asked to provide your Personal and Family Health Information (PFHI). In order for the Test to perform as intended, you must provide accurate and correct information. If another person is submitting your PFHI 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 and correct. If you are providing personal information about your relatives, you also represent and warrant that you have obtained permission from such relatives to disclose such information to Geneticure.
An authorized provider will review your information, and if they determine that the Test is appropriate for you, they will order the Test for you.
You will also be asked to provide a cheek swab sample in accordance with Geneticure’s collection procedures. Your sample and PFHI will be transferred to Geneticure’s dry laboratory in Minnesota, US. Your de-identified sample with DNA will be then transferred to our 3rd party, CAP-accredited laboratory in Arizona, USA for processing, DNA extraction, and genotyping. Genotyped data includes information about genes and regions relevant to the ordered Test, and to those genotypes alone. Because samples frequently include DNA from other sources (e.g., bacteria, food), Geneticure may also test for presence of this DNA for quality control purposes. All genotyped data may be used for regulatory compliance, and de-identified for internal quality control, validation studies, and internal research and development purposes. Following successful genotyping, your DNA sample(s) is(are) destroyed.
Upon successful completion of the Test, you hereby request that a report be made available to you and your ordering provider for review, following an opportunity to schedule genetic counseling, if offered. You should consult with your healthcare provider about your results.
Benefits of the test
The results from your sample will provide a ranked order of likelihood of response to hypertension medications, based on genetics alone. Knowing this information may help your provider make more informed prescribing or dosing decisions that are specific to you, rather than the population as a whole.
Risks of the test
The Test is a genetic test that may cause you to discover sensitive information about your health. 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. While the genotypes assessed in the Geneticure hypertension panel may be associated with a better or worse response to certain medications, they have not been shown to be associated with significant risk of disease (i.e. cancers). Should this status change as new information and research become available, you will be notified.
Limitations of the test
This test does not detect every variant associated with how a person processes or responds to medications. The study of pharmacogenomics, or how the body responds to medications based on DNA, is in its infancy in hypertension. Although a great deal of research has focused on the hypertensive response to therapy according to genetics, and the Geneticure panel assesses many of these common variants, these test results predict how you will respond to therapy based on the latest research and based on genetics alone. Although supported by scientific rigor, and while Geneticure provides an order of pharmacotherapy based on your genes, Geneticure in no way guarantees or warrants that the results delivered are in any way the optimal medication for you, as many factors beyond genetics also play a role in response to treatment.
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. 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 our laboratory informatics and algorithms, you understand and agree that Geneticure may, at its sole discretion, amend or modify your Test report. This may result in a change in the reclassification of a variant; a change or update to a previously reported pharmacogenomic allele; or a reclassification of a reported diplotype. Geneticure will attempt to notify you of any material amendments or modifications. You hereby irrevocably waive any and all claims against Geneticure for any amendment or modification of the Test report in accordance with Geneticure’s standard operating procedures.
Geneticure implements 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, assigned functional, 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. Geneticure expressly disclaims any liability for the inaccuracy of Test results resulting from such conditions or the failure to provide accurate, correct or complete PFHI (including your medication history), and you expressly waive any claims against Geneticure with respect thereto.
Your results may reveal that you may process or respond to certain medications more or less effectively than others. Genetics is only one of the factors influencing medication effectiveness. Your physician can consider this information along with other factors like the influence of other genes, your health history, environmental factors, and other medications. Always consult with a provider before stopping or making any other medication changes. Changing medications on your own could be harmful to your health.
You should consult with your provider, a genetic counselor, or a 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. Geneticure does not provide medical services, diagnosis, treatment, or advice.
Use of Third-Party Physician Groups
If you order directly through us or through a retailer (such as Amazon.com), we employ an independent provider network, PWNHealth, LLC (www.pwnhealth.com), to review health history and test orders to ensure our customers are receiving the best test for their health concerns. PWNHealth also provides genetic counseling if desired by user. The cost of the PWNHealth service is approximately $40 and is included in the price of the Test. PWNHealth is an outside, independent network of healthcare providers. Health professionals from PWNHealth review test requests, identify potential drug-drug interactions, and offer consultation throughout the testing and reporting process.
Privacy and data security
Your privacy is important to Geneticure. Details about Geneticure’s policies governing patient privacy and health information, including patient rights regarding such information, can be found at www.geneticure.com/privacy, or will be made available to you upon request by emailing email@example.com. Geneticure 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). Geneticure implements certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your protected information. Geneticure cannot, however, guarantee the security of any information you transmit to Geneticure or store on the Geneticure website, and you do so at your own risk. You agree that Geneticure 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 Geneticure. 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 Geneticure’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/or your provider as specified in your account or order form. By agreeing to this Informed Consent, you also agree that your genetic information, PFHI, and results can be shared with your ordering provider, and with any healthcare provider that you or your ordering provider designates. You also agree that Geneticure may communicate with you about your collection kit, order, results, account details, and other Test logistics and procedures.
- We 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.
- Geneticure will retain the sample (extracted DNA) only for the maximum duration permitted under applicable law or regulation (“Retention Period”), after which point it will be destroyed.
- 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 PFHI 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.
- 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 Geneticure may de-identify the genotyped genetic information and aggregate this genetic information with de-identified genetic information from other clients.
- You also agree that your genetic information, PFHI, personal data, and results may be stored and used by Geneticure for regulatory compliance purposes.
- Along with your de-identified genetic information, your PFHI, 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 Geneticure.
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 Geneticure 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 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, and verify they are of age.
- This Test is not intended to diagnose whether I have or will get a certain disorder in the future. It is intended to tell me about how my genetics may impact my ability to process and respond to certain medications.
- The reported results and information are intended solely for use by a provider and do not constitute medical advice by Geneticure. 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 Geneticure’s genetic counselors at no additional charge.
- My sample will be genotyped for the genes and regions identified in the Test selected. My genetic information, PFHI, personal data and results may be stored and used by Geneticure for regulatory compliance purposes.
- My sample and all my related personal information will be transferred to Geneticure’s laboratory, or contracted 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 samples will be destroyed after the end of the applicable Retention Period.
- Minors cannot be tested unless the test is prescribed and ordered through their doctor. The consequences of genetic testing of minors are relatively new and less understood. The National Society of Genetic Counselors recommends that the social, psychological and legal risks and benefits of early identification of genetic issues from the perspective of the minor and parent/guardian be carefully considered and include genetic counseling when discussing adult onset disorders.
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 firstname.lastname@example.org.
Version date: November 15, 2018