OneOme RightMed® informed consent for genetic testing

For patients purchasing the test online

This (“Informed Consent”) reviews the benefits, risks, and limitations of the test recipient, which may be you or your dependent, (“Recipient”) undergoing a pharmacogenomic genetic test called the OneOme RightMed comprehensive test (“Test”) provided by OneOme, LLC (“OneOme Testing Laboratory”) and authorizes PWN Remote Care Services (with its contractually affiliated professional entities, collectively, “Affiliated Professional Entities”) (collectively “PWN”), a third party provider and genetic counseling service to assess the Recipient’s information to determine if the Test is appropriate for the Recipient and to assist in understanding the Test and/or the Recipient’s results (the “Services”). It also explains how the Recipient’s information and sample will be used after performance of the Test.

The Recipient is not required to have the Test. Prior to signing this Informed Consent, you 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, you must confirm by agreeing to the consent or otherwise acknowledging that you have read, understood, and agree to this Informed Consent in its entirety.

ONEOME RIGHTMED TEST AND LABORATORY

OneOme operates a clinical 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. The purpose of this test is to assist the Recipient’s physician in determining how the Recipient’s genes may affect the Recipient’s response to certain prescription medications. By agreeing to this Informed Consent, you acknowledge that you have also reviewed and agree to OneOme’s TERMS OF SERVICE and PRIVACY POLICY.

PWN

The services are provided in collaboration with PWN. You acknowledge and agree that the services, including test review, authorization, outreach, and genetic counseling by PWN providers: (a) are provided solely for informational purposes, and do not constitute treatment or diagnosis of any condition, disease or illness, or otherwise constitute the practice of medicine; (b) do not and are not intended to replace the existing primary care or other relationship with the Recipient’s physician or other healthcare provider; (c) are provided by physicians and genetic counselors that do not have the authority to and will not prescribe or order medications or treatments for the Recipient; and (d) are solely for your personal use and are not being used or relied upon as a substitute for the care, medical advice, or treatment provided by the Recipient’s primary care provider or other personal physician.

Your consent is an acknowledgement that you are seeking the Services voluntarily without influence of another party. Advice and consultation provided as part of the Services shall not constitute a treatment decision and you are solely responsible for forwarding the Recipient’s Test results to the Recipient’s primary care or other personal physician and for initiating follow up care, diagnosis, medical treatment, or to obtain confirmation of any interpretation of the Test results you may have received from the Services.

You authorize OneOme to disclose to PWN and PWN to use and disclose to OneOme information, including the health information, provided by the Recipient or on the Recipient’s behalf, including Test results, for the purpose of PWN providing the Services and in accordance with the OneOme Terms of Service and Privacy Policy. Such information may be disclosed and/or exchanged as among OneOme and PWN (including its contractually affiliated professional entities) and physicians, genetic counselors, their staff, agents, designees, and administrative services provider for the purpose set forth above. PWN may use contact information provided by OneOme or you to contact you solely in connection with the Services.

You understand and agree that a fee will be collected by OneOme on behalf of PWN Remote Care Services and its affiliated professional entities (“PWN”), a third party service, for PWN’s services to assess the Recipient’s information and determine if the Test is appropriate for the Recipient. An additional portion of the total fee is collected by OneOme on behalf of PWN for genetic counselor services.

SAMPLE COLLECTION

After the purchase has been placed, the Recipient will be mailed a cheek swab test kit (“Kit”) to provide the Recipient’s DNA sample. A video illustrating how to provide the Recipient’s sample can be found at oneome.com/sample. The Recipient’s sample will then be sent to OneOme Testing Laboratory for analysis.

Biological sample(s) used to perform this test will be destroyed at the end of the testing process or within 60 days of sample receipt. No tests other than those authorized by the test order will be performed by OneOme Testing Laboratory.

PHYSICIAN ORDER PROCEDURE

Completion of a test purchase (“Purchase Form”) and activation form (“Activation Form”) includes Personal Health Information (PHI). In order for the Test to perform as intended, you must provide accurate and correct information.

Upon submitting a completed “Activation Form”, an authorized PWN healthcare provider will review the Recipient’s information, and upon his or her determination that the Test is appropriate for the Recipient, he or she will order the Test. Prior to placing the order, you may be asked to provide additional information or clarify any information that you have provided on the Activation Form.

RESULTS

Upon successful completion of the Test, you will undergo a counseling session with a certified PWN genetic counselor to review the Test results. You may also request that a report be made available to you for review.

The results of the OneOme RightMed comprehensive test will contain medications that are sorted in the following manner:

Red: Major gene-drug interaction:

  • i. medication is broken down or metabolized much slower ("poor") than normal
  • ii. medication is broken down or metabolized much faster ("ultra-rapid") than normal
  • iii. there is high-risk of severe adverse reaction
  • iv. as is typical, it may require a dose adjustment or determination not to use by your healthcare provider

Yellow: Moderate gene-drug interaction:

  • i. medication is broken down or metabolized slower ("intermediate") than normal
  • ii. medication is broken down or metabolized somewhat faster ("normal to ultrarapid") than normal
  • iii. there is an elevated risk of adverse reaction
  • iv. as is typical, it may require a dose adjustment by your healthcare provider

Green: Minimal gene-drug interaction:

  • i. medication is broken down or metabolized at a normal rate
  • ii. there is no known evidence to predict an elevated risk of adverse reaction
  • iii. your healthcare provider should take other factors into consideration even if it may typically be used as directed

The color-coded recommendations take into account:

  • a. the overall break down or metabolism of a drug
  • b. the likelihood for an adverse event to happen
  • c. the severity of the adverse event

BENEFITS OF THE TEST

The Test results may show that the Recipient has mutations in certain regions of the Recipient’s DNA that affect how the Recipient metabolizes certain medications. Knowing this information may help the Recipient’s healthcare provider make more informed prescription decisions.

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, you 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 organ transplant therapies. Although extremely rare, 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 you 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 HTTP://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 your state of residence. You 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.

LIMITATIONS OF THE TEST

The interpretations and clinical annotations provided by OneOme are intended solely for use by a medical professional and do not constitute medical advice by OneOme or PWN. The Recipient’s treating provider remains ultimately responsible for all diagnosis and treatment decisions for the patient. Information included in the Test 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 Test 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, including the ones listed in the Test report, requires careful therapeutic monitoring regardless of any Test-related information you may receive. As a matter of practice, OneOme routinely updates its pharmacogenomic database as new information becomes available to the scientific community. Drug binning and annotations found on the Recipient’s Test report are dependent on the date it was created and/or the database version used to generate that report.

Not all pharmacogenomic tests cover the same drug-gene interactions. 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, changes to published pharmacogenomic guidelines, or assay differences. OneOme and PWN are not in a position and will not compare or analyze differences between the Test and others. If the Recipient has previously taken a pharmacogenomic test before, the Recipient may not need to take the Test at all or seek the advice of the Recipient’s physician or licensed healthcare provider.

DATA PRIVACY AND SECURITY

Details about OneOme’s policies governing patient privacy and health information, including patient rights regarding such information, can be found at WWW.ONEOME.COM/PRIVACY. 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.

PAGE UPDATED AS OF: September 18, 2018