Informed Consent
PHARMACOGENOMIC TESTING: INFORMED CONSENT
Testing for genetic conditions can be complex. You have the right to consult with your physician or obtain professional genetic counseling prior to consenting to genetic testing. Refer to pharmacogentic testing information found at: www.Pro- GeneX.com.
I hereby consent to participate in pharmacogentic testing. I understand that I must provide a biologic specimen by following the instructions found in the swab kit provided by Pro-GeneX Laboratories, Inc. I understand that this biologic specimen will be used for the purpose of obtaining pharmacogentic results. I understand the information listed below and I’ve had the opportunity to contact my provider and discuss any questions I have about this test.
Information about Pharmacogentic Testing:
- Participation in genetic testing is completely voluntary.
- A positive result is an indication that I may be predisposed to or have a specific condition related to the use of certain pharmaceuticals. Further testing may be needed to confirm the results.
- You can request to have your results sent to your physician or genetic counselor for consideration in your healthcare treatment plan.
- Due to limitations in technology and incomplete knowledge of genes, some changes in DNA or protein products that cause disease, may not be detected by the test.
- There may be a possibility that the laboratory findings will be uninterpretable or of unknown significance.
- At this time, it is not standard practice for the laboratory to systematically re-review variants of uncertain significance that have been detected.
- Most tests are highly sensitive and specific. However, sensitivity and specificity are test dependent.
- The tests offered are considered to be the best available at this time. This testing is often complex and utilizes specialized materials; however, there is always a small chance an error may occur.
- Because of the complexity of genetic testing and the important implications of the test results it is recommended that you consult with a physician, genetic counselor, or other identified health care provider. You can request that your test results be sent to your provider at any time.
- Your results are confidential to the extent allowed by law. They will only be released to medical professionals or other parties with your written consent or as otherwise allowed by law.
- Pro-GeneX Laboratories, Inc. is not a specimen banking facility and your sample will not be available after 60 days or for future clinical studies.
- Your specimen will only be used for the genetic testing as authorized by this consent and your sample will not be used in any identifiable fashion for research purposes without your consent.
- Additional testing information can be found at: www.Pro-GeneX.com