How will my sample be used?

My buccal swab sample ("Sample") will be used to test for genetic markers using the Genomind® pharmacogenetic (“PGx”) test, performed by Vanta Diagnostics (“the Performing Laboratory”), which assists clinicians in making treatment decisions based on your genetic profile. Results may indicate which medications are likely to work or cause adverse effects, and I may wish to consult the clinician managing my medications, seek genetic counseling, or consider further independent testing. No other testing will be performed with my Sample other than as described herein.

What are the limitations and risks of the test?

The test will not detect all variants possible within my genes, nor will it indicate if I am allergic to certain medications. Several sources of error are possible, including, but not limited to, clinical misinterpretation, sample misidentification, sample contamination, and inaccurate results due to donor genetic material in transplant recipients. The results of this test may indirectly reveal familial information (e.g., paternity/non-paternity) and/or be indeterminate due to technical limitations.

What are my rights?

I have the right not to agree to have my Sample tested. I may wish to obtain professional genetic counseling prior to consenting to testing. I may withdraw my consent to testing at any time until my results are received by my ordering provider. My Sample and test results are confidential and will be released to me and to the clinician who ordered the test. I may also choose to permit the sharing of my results with other healthcare providers.

I understand that Genomind® PGx is an analysis of genes to identify variations. Variations can help inform my prescribing clinician as to the medication options they recommend for me. I understand the purpose of this test, as well as the limitations and risks.

I consent to the collection of a Sample for myself or any listed minor or other dependent for the purpose of receiving the PGx test. Testing will be performed by Vanta Diagnostics, a CLIA-certified laboratory with Genomind acting as the reporting vendor. I understand that Genomind and its representatives are not responsible for any medical or other decisions made based on the results of the PGx test ordered by a clinician. I agree that I have the authority under the laws of the state or jurisdiction in which I reside to provide this release.

I understand and agree that Genomind, operating under a Business Associate Agreement with Vanta Diagnostics, will gather my Protected Health Information (PHI), as that term is defined by the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (HIPAA). Genomind employs a number of organizational, technical, and physical safeguards designed to protect the confidentiality of my PHI. I understand and agree that Genomind will only use or disclose my PHI with my consent or for purposes of my treatment, payment of my treatment, normal business operations, or as otherwise be permitted by applicable law, including HIPAA.

I understand that after my testing is complete, my leftover Sample may be useful for future research, including future genetic tests. If I consent to allow my leftover Sample to be used for such research, including research conducted by third parties, I understand that my sample will be stripped of all information that identifies me so that the researchers would not be able to identify or link the sample to me. I acknowledge that my sample will be retained and NOT be destroyed within 60 days of testing, as may otherwise be required by state law. The Performing Laboratory's policy is to conduct research in accordance with federal human subject protection laws and applicable privacy laws.

I acknowledge that I am ordering the Genomind PGx test and will receive a report containing my genetic test results. I understand that this test does not include management of my medications and I must consult with my prescriber for questions regarding my current or future medications. I accept full financial responsibility for all costs associated with this test and agree to ensure payment. I understand that this is a self-pay test, and Genomind will not submit claims to my insurance. However, I may be eligible to use my HSA/FSA to cover the cost if applicable.

The use of "I" or "me" or "my" in this document refers to the person for whom testing was ordered by an authorized clinician. I authorize the Performing Laboratory to test my sample. My signature constitutes my acknowledgement that I have read, or have had read to me, all of the above statements, and fully understand and agree to their terms.