Genesis Preventable Cancer (BRCA1/2 Screen) Informed Consent

This consent form reviews the benefits, risks and limitations of undergoing DNA testing for the preventable cancer syndrome(s) available through Genesis that has been prescribed for you. Your sample will not be processed unless you or your provider confirm that you have read and understood the contents of this form. This is a voluntary test. You may wish to seek genetic counselling prior to agreeing to this form.

Purpose

This test is designed to detect genetic changes, called mutations, that are associated with preventable cancer syndromes. preventable cancer syndromes increase an individual’s risk to develop certain types of cancer. Disease descriptions, prognoses, and treatment options may be found on our website: http://www.genesis.org.in/consent/hereditary-cancer and should be discussed with your healthcare provider.

Test results and interpretation

If you have a family history of one of the conditions on the Genesis panel, you should inform the laboratory of the specific gene mutation(s) present in your family. Screening for the gene(s) on our panel may significantly reduce, but cannot eliminate, the likelihood of having or developing an preventable cancer syndrome. The following describes the possible results outcomes:

Positive: A positive result indicates that a gene mutation has been identified and that you are at increased risk to develop certain types of cancer. You may test positive for more than one gene mutation.

Negative: A negative result indicates that no gene mutation was identified. If a mutation was not previously identified in your family, this result may significantly reduce, but cannot eliminate, the likelihood of having an preventable cancer syndrome. Alternatively, if you test negative for a mutation known to be in your family, this result rules out a diagnosis of the same preventable cancer syndrome in you, but does not guarantee that you will be healthy or free from cancer due to environmental or other factors.

Variant of uncertain significance: A finding of a variant of uncertain significance indicates that a change in a gene was detected but it is currently unknown whether that change is associated with an preventable cancer syndrome. A variant of uncertain significance is not the same as a positive result and does not clarify whether you are at increased risk to develop cancer. The reporting of variants of uncertain significance is optional. Please speak with your physician regarding which version of the test is being ordered for you.

Genesis testing is highly reliable with >99% accuracy for targeted regions. As with all medical screening tests, there is a chance of a false positive or false negative result. A “false positive” refers to the identification of a gene mutation that is not present. A “false negative” is the failure to find a mutation that indeed exists.

Result interpretation is based on currently available information in the medical literature and scientific databases. Because literature and scientific knowledge are constantly being updated, new information may replace or add to the information we used to interpret your results. Genesis, at its discretion, may re-analyse test results based on additional information and contact you and/or your provider as appropriate.

Benefits

Your genetic test results may help you and your health care providers make more informed medical management decisions. Your results may also benefit family members. If you test positive for a gene mutation associated with an preventable 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.

Risks

Genetic testing may reveal sensitive information about your health or disease risks. Test results may reveal incidental, unsought information, such as discovering that a man is not the father of a child (non-paternity). Under some circumstances, test results could be used in connection with life insurance coverage.

Limitations

This test is designed to detect DNA mutations associated with preventable cancer syndromes. It cannot detect every mutation associated with every preventable cancer syndrome, nor does it analyse all known preventable cancer syndromes or causes for cancer. Negative results do not guarantee that you or your family members will be healthy and additional testing may still be indicated. Some biological factors, such as a history of bone marrow transplantation or recent blood transfusions limit the accuracy of results. Diagnostic errors may occur due to sample mix-up or contamination. Genesis offers the option to design custom panels as a special service to ordering physicians. As such, Genesis cannot be held liable for any missed mutation/disease detection due to omission of a disease from a clinic’s custom panel.

Research

De-identified samples, clinical information and test results may be stored in a repository and used for validation, educational, and/or research purposes. In addition, this de-identified information may be submitted in a compliant manner to research databases.

Any such research that results in medical advances, including new products, tests or discoveries, may have potential commercial value and may be developed and owned by Genesis or the researchers that analyse the data. If any individuals or corporations benefit financially from studying your genetic material, no compensation will be provided to you or your heirs.

Genesis has no obligation to retain your sample indefinitely and may destroy it once it no longer has a legal duty to retain it. By consenting to this agreement, you provide authorization for Genesis and its partners to use your sample and submitted information for such purposes as mentioned above.

Genesis may also contact you in the future for research opportunities.

Please contact us at contact@genesis.org.in or +91-11-4331-0000 if you wish to opt out of such research or future contact.

International Specimens

IIf you are a patient outside India, you represent that by providing the samples, you are not violating any export ban or other legal restriction in the country of your residence.Confidentiality

Confidentiality

By agreeing to this informed consent, you provide authorization for your results to be disclosed to your ordering physician and other covered entities. Federal law prohibits unauthorized disclosure of confidential personal health information and use of your genetic test results by employers and health insurers. In addition, some states prohibit use of this information by life insurers.

Legal Agreement

You give permission to Genesis, its contractors and assignees to perform genetic testing on the sample you provided and to disclose the results of the testing to your ordering physician. You are not an insurance company or an employer attempting to obtain information about an insured person or an employee. You take full responsibility for all possible consequences if you share your test results with others. You agree to hold and assign harmless Genesis, its employees, contractors and successors from any and all liability arising from your disclosure, whether intentional or inadvertent, of your medical Information and test results to any third parties for diagnostic or any other purposes. You may not permit anyone else under your reasonable authority to copy, modify, create a derivative work of, reverse engineer, decompile or otherwise attempt to extract the source code or other basis of this technology.

Any legal action or proceeding between Genesis and you related to this agreement will be governed exclusively by the laws of New Delhi, India. Any dispute, claim, or controversy in connection with or arising under the use of our Service or this agreement, its construction, existence, interpretation, validity, or any breach hereof which cannot be amicably settled between the parties, shall be finally and exclusively resolved by binding arbitration under the Rules of Arbitration of India then prevailing. The use of arbitration on an individual basis to resolve disputes is required; the right to class arbitrations and class actions is waived under the terms of this Agreement. The arbitration proceedings shall be held in New Delhi, India.

Financial Authorization

By agreeing to this consent, I acknowledge the following:

  • I authorize Genesis to provide my designated insurance carrier or healthcare reimburserany and all of the information, including test results, necessary for processing my insurance claim/reimbursement.
  • I authorize that benefits under this claim be payable exclusively to Genesis. I understand that my insurance carrier or healthcare reimbursermay not approve and reimburse my medical genetic services in full or at all, due to a variety of reasons, including but not limited to, usual and customary rate limits, benefit exclusions, coverage limits, lack of authorization, or medical necessity.
Financial Authorization

By agreeing to this consent, I acknowledge the following:

  • I am either (1) the patient providing the sample and am at least 18 years of age or (2) I have legal authorization to provide this informed consent on behalf of another person.
  • I have read and agree to the contents of this form.
  • I understand the benefits, risks and limitations of genetic testing.
  • I fully comprehend the distinction between risk-reduction and risk-elimination.
  • I have been informed of the availability of genetic counselling services.
  • I have been given the opportunity to discuss the results of the test with my physician, once I receive them.
  • I am responsible for informing my ordering physician of changes in my family history.
  • I understand that Genesis may contact me in the future for research opportunities.
  • I understand that Genesis may use my de-identified information and test results for validation, educational, and/or research purposes, and this data may be submitted in a compliant manner to research databases.

By agreeing to this Informed Consent, you are confirming that you understand the benefits, risks and limitations associated with genetic testing for preventable cancer. Furthermore, you are affirming that you recognize the seriousness of conditions for which you are being tested, and that disease descriptions, prognoses, and treatment options have been made available to you by your healthcare provider. Finally, if you have the legal authorization to provide this informed consent on behalf of another person, you are representing that the sample provided belongs to that person.