Introduction
This form (“Informed Consent”) reviews the benefits, risks, and limitations of taking the OneOme RightMed pharmacogenomic test (“Test”) provided by OneOme, LLC (“OneOme”). It also explains how the Test recipient’s (“Recipient’s”) information and sample will be used after the Test. The Recipient referred to throughout this Consent may refer to yourself, your dependent, or patient if you are reading this and consenting on their behalf. By consenting to the Test on behalf of a Recipient, you acknowledge and represent that you are the Recipient's authorized representative, healthcare provider, and/or legal guardian, and have the legal authority to give informed consent on behalf of the Recipient.
The Recipient is not required to have the Test. Prior to signing this Informed Consent, the Recipient may wish to speak with a genetic counselor, or the Recipient’s ordering or referring healthcare provider for further guidance about the Test. However, in order for us to process the Recipient’s sample and provide the Recipient’s results, the Recipient must acknowledge that they have read, understood, and agree to this Informed Consent in its entirety.
OneOme RightMed® Test and Laboratory
OneOme operates a clinical testing laboratory (“OneOme Testing Laboratory”) in Minneapolis, Minnesota that is accredited by the College of American Pathologists (“CAP”) and meets the certification requirements for high complexity testing established under the Clinical Laboratory Improvement Amendments (“CLIA”). Certifications can be found at WWW.ONEOME.COM/LICENSING. By agreeing to this Informed Consent, Recipient acknowledges that they have also reviewed and agreed to OneOme’s TERMS OF SERVICE, PRIVACY POLICY, and NOTICE OF PRIVACY PRACTICES.
Sample collection & results
After Recipient’s biological sample (e.g., cheek swab, blood) has been collected, the biological sample is returned to OneOme Testing Laboratory for analysis. According to OneOme’s policy, the original biological specimen(s) used to perform this test are destroyed at the end of the testing process or within 60 days of sample receipt. In exceptional cases, an extract may be preserved for up to 2 years for quality assurance purposes only (excludes New York patients). No tests other than those authorized by the order will be reported by OneOme Testing Laboratory. Results will be shared in accordance with OneOme’s PRIVACY POLICY
Benefits of the test
The Test analyzes the Recipient’s DNA and delivers information that may help Recipient’s treating provider(s) make more informed, individualized treatment decisions. This may help Recipient’s physician tailor your medications to meet Recipient’s specific, individual needs.
Risks of the test
Due to the complexity of interpreting some genetic test results, such as those that may carry a probabilistic risk of disease, Recipient should consider the benefits of consulting with a trained genetic counseling professional, physician, or pharmacogenomic specialist. In some cases, assays may be subject to general interference by factors such as PCR inhibitors and low quality or quantity of extracted DNA. When present, these interferents typically yield no result rather than an inaccurate one. Very infrequent mutations or polymorphisms occurring in primer- or probe-binding regions may also affect testing and could produce an erroneous result or assay failure. Test results and clinical interpretation may be inaccurate for individuals who have undergone or are receiving non-autologous blood transfusions, tissue, and/or bone marrow or liver transplant therapies. In certain circumstances, a Test result is impossible, and the sample will be rejected. If a sample is rejected the first time, the sole remedy may be a one-time repeat Test. Although rare, Test results could also be impacted by other factors not addressed above, such as laboratory error.
In addition, the Test will also provide limited secondary findings that may cause Recipient to discover sensitive information about the Recipient’s health or disease risks. The US Genetic Information Nondiscrimination Act of 2008 prohibits discrimination on the basis of genetic information with respect to health insurance and employment. For more information about this, visit HTTPS://WWW.GENOME.GOV/10002328/. However, there are currently no US federal laws that prohibit discrimination in life insurance, disability insurance or long-term care insurance, which may be specific to Recipient’s state of residence. Recipient must consider the full and possible impact of the Recipient’s Test results as these relate to insurance rates, obtaining disability or life insurance, and employment. Review the full INDICATIONS FOR USE.
Limitations of the test
The Test results provided by OneOme are intended solely for use by a medical professional and do not constitute medical advice by OneOme. The Test results are not an indicator of the Recipient’s health status. The Recipient’s treating provider remains ultimately responsible for all diagnosis and treatment decisions for the patient. OneOme disclaims liability for any errors, omissions or ambiguities in any translation or interpretation of a report by a third party, including without limitation direct, indirect, incidental, special, consequential or exemplary damages, whether such damages arise in contract, negligence, tort, under statute, in equity, at law or otherwise. Information included in the Report is based upon scientific literature and does not take into account other genetic variations, environmental or social factors that may affect the Recipient’s results. Other factors that may impact genomic results that are NOT included in the Report include, but are not limited to, environmental factors (e.g., smoking), health factors (e.g., diet), social and familial factors, various medical conditions, and drug-drug interactions. Administration of any medication requires careful therapeutic monitoring regardless of any Test-related information Recipient may receive.
Not all pharmacogenomic tests cover the same genes and alleles. If the Recipient has had a prior pharmacogenomic test, results from this Test may be duplicative or may vary due to different genes or alleles being tested, or assay differences. OneOme is not in a position to, and will not, compare or analyze differences between the Test and others. If the Recipient has previously taken a pharmacogenomic test before, the Recipient should seek the advice of the Recipient’s physician or licensed healthcare provider to determine whether the test should be taken again. The effect of pregnancy on PGx interpretation is not well studied. It is recommended to proceed with PGx testing using standard caution interpreting the results if the Recipient may be pregnant.
Limitation of liability
By agreeing to take the Test, Recipient waives, releases, and agrees to hold harmless OneOme and its affiliates or their past or present officers, directors, employees, and agents from any legal claims, rights, or causes of action Recipient may have in connection with the Recipient’s Test results and/or Recipient’s use of the testing service. OneOme disclaims any liability arising out of Recipient’s use of the testing service or for any adverse outcomes from Recipient’s use of the information provided by OneOme for any reason, including but not limited to any misunderstanding or misinterpretation of the information provided through the testing service.
OneOme notice of privacy practices
Details about OneOme’s policies governing patient privacy and health information, including patient rights regarding such information, can be found in the OneOme NOTICE OF PRIVACY PRACTICES. OneOme complies with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (as amended) regarding the Recipient’s personal health information
Financial evaluation for OneOme's financial assistance program
This section is only applicable to Recipients with commercial health insurance coverage or no health insurance coverage. This section does not apply to Recipients with health insurance coverage through a Federal healthcare program (e.g., Medicare, Medicaid, Medicare Advantage, TRICARE).
By agreeing to take the Test, Recipient gives OneOme permission to conduct a financial evaluation through Experian. This evaluation determines if you qualify for OneOme's Financial Assistance Program, which offers eligible patients access to the Test for $199 or less. To do this, OneOme will share your name, address, and date of birth with Experian. This program involves checking your credit report with a "soft inquiry," which does not impact your credit score and is not visible to other creditors. If you have any questions or wish to avoid this soft inquiry, please contact OneOme.
Recipient consent to use and disclosure of personal information
By agreeing to this Informed Consent, Recipient acknowledges and agrees to:
- The using and sharing of personal information and Test results about the Recipient by and between OneOme and the Recipient’s health care providers for treatment purposes.
- The sharing of minimum necessary personal information about the Recipient by OneOme and the Recipient’s health care providers with the Recipient’s health insurance providers for purposes of payment and health care operations.
- OneOme aggregating and de-identifying personal information and Test results about the Recipient which will be used to improve the Test and increase testing accuracy. This aggregate data will be altered to prevent identifying individual patients.
- The uses and disclosures outlined in the OneOme NOTICE OF PRIVACY PRACTICES..
PAGE UPDATED AS OF: November 20, 2023