This consent form reviews the benefits, risks and limitations of undergoing DNA testing for the inherited cancer syndrome(s) available through Counsyl, 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 counseling prior to agreeing to this form.
This test is designed to detect genetic changes, called mutations, that are associated with inherited cancer syndromes. Inherited cancer syndromes increase an individual’s risk to develop certain types of cancer. Disease descriptions, prognoses, and treatment options may be found in the Inherited Cancer Screen section of our website and should be discussed with your healthcare provider.
If you have a family history of one of the conditions on the Counsyl 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 inherited 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 inherited 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 inherited 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 inherited 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.
Counsyl 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. Only variants in the genes requested by the ordering physician will be reported. Incidental/secondary findings will not be reported. Counsyl does not routinely re-analyze test results or issue new test reports, and has no obligation to do so.
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 inherited 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.
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.
This test is designed to detect DNA mutations associated with inherited cancer syndromes. It cannot detect every mutation associated with every inherited cancer syndrome, nor does it analyze all known inherited 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. Counsyl offers the option to design custom panels. Counsyl will only interpret and report on the gene(s) requested by the ordering physician and will not report incidental/secondary findings. As such, Counsyl cannot be held liable for any missed mutation/disease detection due to omission of a disease from a clinic’s or ordering provider’s custom panel.
Samples, clinical information and test results may be stored in a repository and used for validation, educational, and/or research purposes. In addition, de-identified information may be submitted in a HIPAA-compliant manner to research databases. Samples from residents of New York state will not be included in research studies and will not be retained for more than 60 days after collection.
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 Counsyl or the researchers that analyze the data. If any individuals or corporations benefit financially from studying your genetic material, no compensation will be provided to you or your heirs.
Counsyl 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 Counsyl and its partners to use your sample and submitted information for such purposes as mentioned above.
Counsyl may also contact you in the future for research opportunities.
If you are a patient outside the United States, you represent that by providing the samples, you are not violating any export ban or other legal restriction in the country of your residence.
Genetic information is protected under the federal Genetic Information Nondiscrimination Act, which generally prohibits health insurers and employers from discriminating against you based on your genetic information. However, you should be aware that there are certain limitations to the protections afforded by this law. By agreeing to this informed consent, you provide authorization for your results to be disclosed to your ordering physician or other covered entities for purposes of treatment, payment or health care operations and to any other party to whom you have authorized Counsyl to release your results. You acknowledge that you have read and understand Counsyl’s Notice of Privacy Practices. You agree Counsyl is not liable for the unauthorized release of your results or medical information, unless such unauthorized release was the result of gross negligence or willful misconduct on the part of Counsyl. You acknowledge that certain email, SMS, telephone or video communications may not be encrypted and/or secure, and unless you request that Counsyl not contact you by these means, there are risks with such unsecured communications.
You give permission to Counsyl, 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 and any other person you have designated. You are not an insurance company or an employer attempting to obtain information about an insured person or an employee.
Any legal action or proceeding between Counsyl and you related to this agreement or Counsyl’s products or services will be governed exclusively by the laws of the State of California. It is understood that any dispute, claim, or controversy arising in connection with this agreement or the use of Counsyl’s products or services, including, but not limited to, claims as to whether any services rendered by Counsyl or persons employed or engaged by Counsyl were unnecessary or unauthorized or were improperly, negligently, or incompetently rendered, shall be finally and exclusively resolved by binding arbitration under the American Arbitration Association’s Commercial Arbitration Rules and Mediation Procedures and Consumer-Related Disputes Supplementary Procedures, and not by a lawsuit or resort to court process, except as California law provides for judicial review of arbitration proceedings. Both parties to this agreement are giving up their constitutional right to have such dispute decided in a court of law before a jury, and instead are accepting the use of arbitration. The parties agree that the arbitrator shall have exclusive authority to resolve any dispute relating to the interpretation, applicability, enforceability or formation of this agreement to arbitrate. Any such controversy or claim shall be arbitrated on an individual basis. The arbitration shall be held in San Mateo County, California.
You understand and agree that this agreement to arbitrate binds you and anyone else who may have a claim arising out of or related to all products and services provided to you by Counsyl or persons employed or engaged by Counsyl. You may cancel this agreement to arbitrate by giving written notice to Counsyl within 30 days of the date of your acceptance. Should you choose to withdraw from the arbitration provision, all other provisions of this agreement shall remain in full force and effect.
By agreeing to this consent, I acknowledge the following:
By agreeing to this consent, I acknowledge the following:
By agreeing to this Informed Consent, you are confirming that you understand the benefits, risks and limitations associated with genetic testing for inherited 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.