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myriad informed consent policies

Please review this information carefully alone or with your doctor. This is a voluntary test. You may wish to seek genetic counseling prior to testing.

MYRISK® HEREDITARY CANCER
FORESIGHT® CARRIER SCREEN
PREQUEL™ PRENATAL SCREEN

MYRIAD MYRISK INFORMED CONSENT 

PURPOSE 

  • This test analyzes a specific gene or gene(s) for genetic changes called mutations. The gene(s) analyzed are associated with specific hereditary cancer risks. This test will help determine if a person has a significantly increased risk of developing certain tumors due to a mutation(s) in a cancer-predisposing gene(s). Genetic testing allows a more precise estimate of an individual’s risk for hereditary cancer than personal and family history alone. In some cases the results of this testing may also provide information about risks for non-cancer related medical conditions.

PROCEDURE

  • Usually, a tube(s) of blood will be drawn or a saliva sample will be obtained and sent to Myriad Genetic Laboratories, Inc. (“Myriad”). In some instances other types of cells will be submitted. Myriad will analyze the DNA of a specific gene or genes to look for mutations associated with specific hereditary cancer risks. Additional information about the testing and the genes analyzed for each of the specific tests available can be found on Myriad’s patient website at http://www.MySupport360.com.

YOUR RESULTS AND INTERPRETATION 

Your results should be evaluated in the context of personal and family health history, the results of physical examination, laboratory and hospital tests, and the clinical impression of your healthcare provider. Possible result outcomes include positive, negative and uncertain.

  • Positive – A mutation that is associated with an increased risk for hereditary cancer was identified. Knowing this information may help you and your doctor make more informed choices about your health care, such as screening, risk-reducing surgeries and preventive medication strategies.
  • Negative – A mutation was not identified in any of the genes included as part of your testing.
    • If you are the first person tested in your family, you still have at least the same risk of cancer as does a person in the general population. You may still be at greater than average risk for hereditary cancer due to a genetic predisposition that cannot be detected by this test, either in the gene(s) for which you were tested or in another gene linked to hereditary cancer.
    • If you test negative for a mutation known to be in your family, you may be considered to have the same genetic risks as others in the general population.
  • Uncertain – A genetic change was detected but it is not known if this change is linked to cancer risk. You still have at least the same risk of cancer as the general population. In addition, you may still be at greater than average risk due to this change or a genetic predisposition that cannot be detected by this test, either in the gene(s) for which you were tested or in another gene linked to hereditary cancer.

Genetic tests results have implications for blood relatives. In consultation with an appropriate healthcare provider, you may wish to discuss sharing your test results with certain blood relatives who may be at risk. If you decide to do this, you should also consider the best way to make this disclosure.

Myriad keeps test results confidential and is fully in compliance with all Health Insurance Portability and Accountability Act (HIPAA) regulations. Myriad will only release your test results to your healthcare provider, his or her designee, or to another healthcare provider as directed by you (or a person legally authorized to act on your behalf) in writing, or otherwise as required by federal and state laws.

BENEFITS 

  • Your genetic test results may help you and your doctor make more informed choices about your health care, such as screening, risk-reducing surgeries and preventive medication strategies.
  • The identification of gene mutation(s) in a family enables other blood relatives to determine whether or not they share the same hereditary cancer risks. If you are positive, you should discuss with your healthcare provider how hereditary cancer is inherited and learn about the chance your children and blood relatives may have inherited the same mutation(s) in the gene(s) tested.
  • If you test negative for a known mutation in your family, you cannot pass on that mutation to your children and you may be considered to have the same genetic risks for cancer as others in the general population.

RISKS 

  • Genetic testing requires DNA most often provided from a sample of blood or from a saliva sample. Side effects of having blood drawn are uncommon, but may include dizziness, fainting, soreness, bleeding, bruising and rarely, infection.
  • To address concerns regarding possible health insurance discrimination, most states and the federal government have enacted laws to prohibit genetic discrimination. In addition, some states have enacted laws that limit use of this information by life insurers and by employers. Furthermore, broad federal legislation prohibits unauthorized disclosure of confidential personal health information.

LIMITATIONS

  • This test analyzes only certain important gene(s) associated with specific hereditary cancer risks. Genetic testing clarifies cancer risks for only those cancers related to the genes analyzed.
  • If you are found to be a carrier of a gene that predisposes you to cancer, there may be differing opinions among physicians about the best steps to take. Your medical care is best determined by you in consultation with your healthcare provider.
  • Analysis for a specific genetic variant of uncertain significance may be considered investigational and may not provide additional cancer risk information to blood relatives.

FOR THE STATE OF NEW YORK

  • The State of New York requires that samples be destroyed at the end of the testing process or not more than sixty days after the sample was taken

NEW INFORMATION AND FUTURE CORRESPONDENCE 

  • Due to the dynamics of this field, there continues to be new information and data that may change the interpretation of your test results. It is recommended that you keep in contact with your healthcare provider, at least annually, to learn of any changes to the interpretation of your results or new developments in cancer genetics and to provide any updates to your personal or family history which may affect your cancer risks.

MYRIAD FORESIGHT INFORMED CONSENT 

PURPOSE 

  • The Foresight Carrier Screen is designed to determine whether you carry genetic changes, called mutations, that could cause serious genetic conditions in your children.
  • For most of the conditions on the panel, both parents must carry a mutation in the same gene for their children to be at risk of developing symptoms. However, there are certain conditions on the Foresight Carrier Screen for which only the mother needs to carry a mutation for her children to be at risk of developing symptoms.
  • More information about each of the conditions on the Foresight Carrier Screen panel can be found at myriadwhstage.wpengine.com/foresight.

BENEFITS 

  • Your Foresight Carrier Screen results can help you and your partner make more informed decisions regarding your family, particularly if screening is performed prior to pregnancy.
  • If it is early in your pregnancy, you can pursue further testing to determine if the pregnancy is affected, and receive guidance from your healthcare provider about how best to plan and prepare for birth.
  • Your Foresight Carrier Screen results may also benefit your other family members. If you test positive, your biological relatives are more likely to test positive for the same mutation(s), thereby allowing them to discover previously unknown conditions and risks.

WHAT YOU MIGHT LEARN

  • Carrier (Positive): A positive test result indicates that a mutation has been identified and that you are a carrier of the indicated condition. You may be identified as a carrier for more than one condition. Carriers usually do not experience symptoms of the condition.

  • No mutations detected (Negative): A negative test result indicates that no gene mutations were identified. This reduces but does not eliminate the possibility of you being a carrier for a condition on the panel.

PROCEDURE 

  • The Foresight Carrier Screen can be done before pregnancy or early in pregnancy, as ordered by your healthcare provider.
  • A small saliva or blood sample is taken and sent to Myriad 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 Foresight Carrier Screen is not intended to detect all genetic mutations.
  • You and your healthcare provider together may decide which version of the Foresight Carrier 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 mutation that is not present.
    • A “false negative” is the failure to detect 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 Foresight Carrier 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.
  • If you and your partner have both received Foresight Carrier Screen testing, the status of each of your tests and your individual results may be revealed to one another and to each other’s ordering providers.
  • Your Foresight Carrier Screen results will be reported to your healthcare provider or his/her agent.
  • By agreeing to testing and signing this consent, you hereby authorize Myriad to share your Foresight Carrier Screen results with other authorized representatives that you’ve identified to Myriad or your healthcare provider, or as otherwise allowed by law.
  • Myriad 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 Myriad to share these results with you and your healthcare provider.
  • You authorize Myriad to contact you about your screen, test or sample, as well as additional products or services offered as part of your Foresight Carrier Screen (e.g., cost estimates), as well as about additional products and/or offers that may be relevant and/or interesting to you.
  • When receiving notifications from Myriad and its affiliates (“Myriad”), email, SMS, and text message may be sent to you to inform you that Myriad has prepared an estimate of your testing costs and to provide you status updates about your test and results. These communications may be unsecure and carry typical risks associated with such transmissions. By agreeing to testing and signing this consent, you agree that (a) you understand the foregoing warning and understand the typical risk of email, SMS, and text message transmissions, and (b) you give Myriad permission to communicate with you by email, SMS, or text message.
  • Please refer to Myriad’s Notice of Privacy Policy, available on the Myriad website, for additional information about Myriad’s privacy practices, including how your protected health information (including your samples and genetic information) may be shared with third-party vendors and service providers that we partner with to provide testing services to you.

RESEARCH

  • Unless you contact us to tell us otherwise, by agreeing to testing and signing this consent, you authorize Myriad 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 Myriad to contact you about potential educational and/or research opportunities.
  • Please contact us at prenatalsupport@myriad.com or +1-888-268-6795 if you wish to opt out of such research or future contact.

FINANCIAL RESPONSIBILITY 

  • By agreeing to testing and signing this consent you authorize Myriad to submit to your insurance carrier any and all of the information, including test results, necessary for processing your insurance claim.
  • Definition of medical necessity and coverage may vary based on payor medical policy. If you are using insurance, your Foresight Carrier Screen disease panel may be modified to align with the medical policy of your insurance carrier.
  • By agreeing to testing you also authorize Myriad to obtain a consumer credit report on you from a consumer reporting agency selected by Myriad. You understand and agree that Myriad may use your consumer credit report to confirm whether your income qualifies you for financial assistance. You further understand that this is not a credit application and will not impact your credit score.
  • If you qualify for financial assistance, you agree to provide Myriad with any additional information or documentation that may be needed to confirm your qualification for the financial assistance program.
  • If your insurance carrier does not reimburse Myriad in full or in part because your insurance carrier determines the Foresight Carrier 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 or the Services are being performed during pregnancy. I represent and warrant that I have the right, authority and capacity to consent to testing and am at least 18 years old or am taking this test during pregnancy.

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 Myriad.

MYRIAD PREQUEL INFORMED CONSENT 

PURPOSE 

  • The Prequel Prenatal Screen is a non-invasive prenatal screen that uses cell-free DNA to assess the risk of a current pregnancy having a chromosome condition, such as Down syndrome.
  • The Prequel Prenatal Screen is intended for women who are at least 10 weeks pregnant with a single fetus or twins.
  • A screening test indicates whether there is an increased or decreased chance for a condition while a diagnostic test indicates whether the condition is actually present or not. The Prequel Prenatal Screen is a screening test.
  • More information about each of the conditions included in the Prequel Prenatal Screen can be found at myriadwhstage.wpengine.com/Prequel. For all of these conditions, severity can vary.

BENEFITS 

  • Compared to other screening methods, non-invasive prenatal screening has fewer false positives and false negatives. This can lead to fewer unnecessary invasive tests like chorionic villus sampling (CVS) or amniocentesis. More information is available at myriadwhstage.wpengine.com/Prequel.
  • Your results may help you and your healthcare provider make more informed medical management decisions.

WHAT YOU MIGHT LEARN

  • The Prequel Prenatal Screen evaluates chromosome 13, chromosome 18 and chromosome 21. You and your healthcare provider may select additional studies to be ordered. Please speak with your healthcare provider regarding which version of the test you would like ordered for you.
  • The following describes the possible results for the Prequel Prenatal Screen:
    • Positive: An “Aneuploidy Detected” or “Aneuploidy Suspected” result indicates that analysis of cell-free DNA in the mother’s blood is consistent with an increased risk of the current pregnancy having the conditions(s) indicated (e.g., Down syndrome). Your may receive a positive result for more than one condition.
      • All “positive” results should be discussed with your healthcare provider to determine next steps, including pursuing diagnostic testing (such as chorionic villus sampling and/or amniocentesis) and additional evaluation, as well as genetic counseling. While follow-up testing is recommended according to professional guidelines, the decision of whether to pursue additional testing is entirely yours and should be made in consultation with your healthcare provider.
    • Negative: A “No Aneuploidy Detected” or “No Abnormality Detected” result indicates a reduced risk of your pregnancy being affected by the conditions being screened.
      • This result indicates a significantly reduced likelihood, but does not entirely eliminate the possibility, of your pregnancy being affected by one of these syndromes.
      • In addition, this result does not guarantee that your pregnancy will be healthy. If you wish to further reduce the risk of an affected pregnancy, additional testing may be available.

PROCEDURE 

  • The Prequel Prenatal Screen can be done 10 weeks into your pregnancy or later.
  • A blood sample is taken from your arm and sent to Myriad for screening.
  • Except in rare cases, your sample will be kept a maximum of 180 days.*

RISKS 

  • Non-invasive prenatal screening may reveal sensitive information about the health of your pregnancy or, rarely, your own health.
  • Your results may lead to your healthcare provider recommending additional testing and evaluation of your pregnancy, or otherwise impact your medical decisions.
  • This test may provide information that can have an impact on your medical decisions.

LIMITATIONS

  • The Prequel Prenatal Screen is designed to detect changes in the chromosomes associated with known syndromes in a current pregnancy. It cannot detect every case, nor does it look for all known genetic diseases or syndromes.
  • Only changes in the chromosomes associated with the conditions requested by the ordering healthcare provider will be reported. Your report will indicate which conditions are included.
  • Noninvasive prenatal screening results can reduce, but cannot eliminate, the likelihood a pregnancy has any changes in the chromosomes.
  • 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 an increased risk of changes in the chromosomes when in fact none is present.
    • A “false negative” is the failure to find an increased risk of a change in the chromosomes in a pregnancy that is affected.
  • It is important for any relevant personal medical history, family history, and pregnancy history to be communicated to your healthcare provider and Myriad for accurate interpretation of your results.
  • The Prequel Prenatal Screen can be performed on singleton or twin pregnancies only. Additional studies are limited in twin pregnancies.
  • Additionally, pregnancies that have experienced the demise of one or more fetuses may not receive reliable results. Please check with your healthcare provider.
  • If either the patient or the pregnancy has cells with different chromosome contents (called “mosaicism”), the results of the Prequel Prenatal Screen may not be accurate.
  • 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 Prequel Prenatal Screen results will be reported to your healthcare provider or his/her agent.
  • By agreeing to testing and signing this consent, you hereby authorize Myriad to share your Prequel Prenatal Screen results with other authorized representatives that you’ve identified to Myriad or your healthcare provider, or as otherwise allowed by law.
  • Myriad 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 Myriad to share these results with you and your healthcare provider.
  • You authorize Myriad to contact you about your screen, test or sample, as well as additional products or services offered as part of your Prequel Prenatal Screen (e.g., cost estimates), as well as about additional products and/or offers that may be relevant and/or interesting to you.
  • When receiving notifications from Myriad and its affiliates (“Myriad”), email, SMS, and text message may be sent to you to inform you that Myriad has prepared an estimate of your testing costs and to provide you status updates about your test and results. These communications may be unsecure and carry typical risks associated with such transmissions. By agreeing to testing and signing this consent, you agree that (a) you understand the foregoing warning and understand the typical risk of email, SMS, and text message transmissions, and (b) you give Myriad permission to communicate with you by email, SMS, or text message.
  • Please refer to Myriad’s Notice of Privacy Policy, available on the Myriad website, for additional information about Myriad’s privacy practices, including how your protected health information (including your samples and genetic information) may be shared with third-party vendors and service providers that we partner with to provide testing services to you.

RESEARCH*

  • Unless you contact us to tell us otherwise, by agreeing to testing and signing this consent, you authorize Myriad 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 compensated for this use.
  • Myriad may collect additional information regarding the outcome of your pregnancy from your healthcare provider for purposes of quality assurance and research.
  • De-identified information may additionally be submitted to external research databases.
  • You authorize Myriad to contact you about potential educational and/or research opportunities.
  • Please contact us at prenatalsupport@myriad.com or +1-888-268-6795 if you wish to opt out of such research or future contact.

FINANCIAL RESPONSIBILITY 

  • By agreeing to testing and signing this consent you authorize Myriad to submit to your insurance carrier any and all of the information, including test results, necessary for processing your insurance claim.
  • By agreeing to testing you also authorize Myriad to obtain a consumer credit report on you from a consumer reporting agency selected by Myriad. You understand and agree that Myriad may use your consumer credit report to confirm whether your income qualifies you for financial assistance. You further understand that this is not a credit application and will not impact your credit score.
  • If you qualify for financial assistance, you agree to provide Myriad with any additional information or documentation that may be needed to confirm your qualification for the financial assistance program.
  • If your insurance carrier does not reimburse Myriad in full or in part because your insurance carrier determines the Prequel Prenatal 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 or the Services are being performed during pregnancy. I represent and warrant that I have the right, authority and capacity to consent to testing and am at least 18 years old or am taking this test during pregnancy.

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 Myriad.