Counsyl Prelude 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 signing this form.

PURPOSE

  • The Prelude 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 Prelude 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 Prelude Prenatal Screen is a screening test.
  • More information about each of the conditions included in the Prelude Prenatal Screen can be found at counsyl.com/prelude. 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 counsyl.com/prelude.
  • Your results may help you and your healthcare provider make more informed medical management decisions.

WHAT YOU MIGHT LEARN

  • The Prelude 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 Prelude 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 Prelude Prenatal Screen can be done 10 weeks into your pregnancy or later.
  • A blood sample is taken from your arm and sent to Counsyl 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.

LIMITATIONS

  • The Prelude 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.
  • Non-invasive 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 Counsyl for accurate interpretation of your results.
  • The Prelude 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 Prelude 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 Prelude 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 Counsyl to share your Prelude Prenatal 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 Prelude Prenatal 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.
  • Counsyl 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 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 Prelude 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 Counsyl.

I HAVE READ OR HAVE HAD READ TO ME AND UNDERSTAND ALL OF THE ABOVE INFORMATION AND HAVE HAD AN OPPORTUNITY TO ASK QUESTIONS ABOUT THE PURPOSE, PROCEDURE, RISKS, BENEFITS AND LIMITATIONS OF TESTING.

I HAVE DECIDED TO PURSUE TESTING and to be bound by the terms of this Consent and any policies referenced herein.

OR

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