Counsyl Reliant Informed Consent

Please review this information carefully and then indicate with your signature if you wish to move forward with testing. This is a voluntary test. You may wish to seek genetic counseling prior to consenting to testing.

PURPOSE

  • The Reliant Cancer Screen is designed to detect genetic changes, called mutations, that have been associated with hereditary cancer syndromes.
  • Hereditary cancer syndromes increase an individual’s risk of developing certain types of cancer.
  • More information about the genes on the Reliant Cancer Screen panel can be found at counsyl.com/reliant.

BENEFITS

  • Your Reliant Cancer Screen results may help you and your healthcare provider make more informed choices about cancer screening and prevention.
  • Your results may also benefit family members. If you test positive for a gene mutation associated with a hereditary cancer syndrome, your biological relatives can be tested for the same mutation in order to determine if they also have an increased risk to develop cancer.

WHAT YOU MIGHT LEARN

  • Results should be interpreted by a healthcare provider in the context of your personal and family medical history.
    Possible results are:
  • Positive: A positive result means that we have identified a mutation in one of the genes tested, which is known to cause an increased risk of developing one or more types of cancer over your lifetime. A positive result does not mean that you have cancer or that you will get cancer. You may test positive for more than one gene mutation.
  • Negative: A negative result indicates that no gene mutation was identified. A negative result does not mean that you will never develop cancer. You may still be at increased risk for cancer, compared to the general population, especially if you have a strong personal or family history of the disease.
  • Variant of uncertain significance: Sometimes a change is identified in a gene, but there is no conclusive evidence that it either increases risk for cancer or is benign. These types of changes are called “variants of uncertain significance” and they are quite common. Professional societies recommend that variants of uncertain significance be treated as negative results when it comes to making clinical decisions.
  • Counsyl periodically evaluates the evidence available for variants to determine if a variant should be reclassified. If a variant is reclassified in a manner that affects your results, Counsyl will reissue your report to your provider. It is recommended that you keep in contact with your healthcare provider in order to learn about any changes to the interpretation of your results or new developments in cancer genetics. You should also update your healthcare provider about any changes in your personal or family history, as they may affect your risks.

PROCEDURE

  • A small saliva or blood sample is taken and sent to Counsyl for screening.
  • Except in rare cases, your sample will be kept a maximum of 180 days.*

RISKS

  • Genetic testing may reveal sensitive information about your health and that of your family members.
  • This test may provide information that can have an impact on your medical decisions.

LIMITATIONS

  • The Reliant Cancer Screen is designed to detect DNA mutations associated with certain known hereditary cancer syndromes. It cannot detect every mutation associated with every hereditary cancer syndrome, nor does it analyze all known hereditary cancer syndromes or causes for cancer.
  • You and your healthcare provider together may decide which version of the Reliant Cancer Screen will be ordered for you. Your report will indicate which genes are included in your analysis and only variants in those genes requested will be reported.
  • As with all medical screening tests, there is a chance of error, including a false positive or false negative result.
    • A “false positive” refers to identifying a gene mutation that is not present.
    • A “false negative” is the failure to find a mutation that is present in the sample.
  • Certain factors, such as having blood cancer, prior blood transfusions, or previous bone marrow transplants can affect the accuracy of the Reliant Cancer Screen results. Be sure to discuss your medical history with your healthcare provider.
  • Occasionally it may not be possible to provide a result. A repeat specimen may be requested.

PRIVACY

  • Genetic information is protected under the federal Genetic Information Nondiscrimination Act (GINA), which generally prohibits health insurers and employers from discriminating against you based on your genetic information. However, you should be aware current federal laws do not specifically prohibit genetic discrimination in life insurance, long-term care insurance and disability insurance. More information about GINA and its limitations is available at ginahelp.org.
  • Your Reliant Cancer Screen results will be reported to your healthcare provider or his/her agent.
  • By agreeing to testing and signing this consent, you hereby authorize Counsyl to share your Reliant Cancer Screen results with other authorized representatives that you’ve identified to Counsyl or your healthcare provider, or as otherwise allowed by law.
  • Counsyl may find information that is not included in the original test requested by your healthcare provider and may report these additional results, if clinically relevant. You authorize Counsyl to share these results with you and your healthcare provider.
  • You authorize Counsyl to contact you about your screen, test or sample, as well as additional products or services offered as part of your Reliant Cancer Screen (e.g., cost estimates), as well as about additional products and/or offers that may be relevant and/or interesting to you.
  • Please refer to Counsyl’s Notice of Privacy Policy, available on the Counsyl website, for additional information about Counsyl’s privacy practices.

RESEARCH*

  • Unless you contact us to tell us otherwise, by agreeing to testing and signing this consent, you authorize Counsyl and its partners to use your sample and any information derived from your sample or otherwise collected about you for educational and/or research purposes. You will not be paid for this use.
  • De-identified information may additionally be submitted to external research databases.
  • You authorize Counsyl to contact you about potential educational and/or research opportunities.
  • Please contact us at support@counsyl.com or +1-888-COUNSYL if you wish to opt out of such research or future contact.

FINANCIAL RESPONSIBILITY

  • By agreeing to testing and signing this consent you authorize Counsyl to submit to your insurance carrier any and all of the information, including test results, necessary for processing your insurance claim.
  • If your insurance carrier does not reimburse Counsyl in full or in part because your insurance carrier determines the Reliant Cancer Screen is not a covered service, is not medically necessary, or for any other reason, you agree to be responsible for payment if you choose to proceed with the screen.

*Samples from residents of New York state will not be retained for more than 60 days after collection and will not be included in research studies.

This test is available only to individuals who are at least 18 years old. I represent and warrant that I have the right, authority and capacity to consent to testing and am at least 18 years old.

In addition, I represent and warrant that (1) all information that I have submitted or that is submitted on my behalf is complete, accurate and truthful, and (2) in the event that I have allowed a third party to assist me in providing any information, I have reviewed and confirmed that all such information is complete, accurate and truthful prior to its submission to Counsyl.

OR

I HAVE DECIDED NOT TO PURSUE TESTING and will discuss next steps with my healthcare provider.