You are ordering one or more genetic screens or tests offered by Healthspan’s partner, Invitae Corporation (“Invitae”). More information about the screen(s) or test(s) ordered is available from Healthspan and can also be found on the Invitae website (www.invitae.com).
How is screening performed?
Screening is performed on a small sample of your blood, saliva, or isolated DNA. Once collected, the sample will be sent to Invitae to perform the screen. During processing, Invitae will look for changes in the DNA sequence, known as “variants.”
What might you learn from this screening?
The results of this DNA screen could be:
a. Positive, and may:
i. alert you to a predisposition or an increased risk for developing a genetic disease in the future.
ii. have implications for risk of disease in other family members.
b. Carrier, and may:
i. indicate that you carry a genetic change that does not increase your own risk of developing a specific medical condition, but that may be passed within your family (also known as carrier status).
c. Negative, and may:
i. indicate disease risks close to that of the general population but not eliminate the risk for developing a genetic disease in the future.
What are the risks and limitations of this screen?
This screen may or may not help your healthcare provider better understand your health and management options. Some types of DNA variants that could cause a specific genetic disorder may not be detected by this screen. When available, testing an affected family member may be more informative. As with all molecular genetic tests, Invitae’s test has technical limitations that may prevent detection of some rare gene variants, or may give an inaccurate result, due to: poor DNA quality, rare technical errors in the laboratory, incorrect reporting of family relationships or clinical diagnosis information, or other types of limitations. In some circumstances, additional testing or testing of other family members may be appropriate and provide additional information. Invitae generates a report for the genes that you have ordered and will not report variants of uncertain significance. In the course of performing the ordered tests, Invitae may rarely find variants that are unrelated to any concern that prompted your having the test but are associated with a significant risk for another condition that could negatively impact your health. These are known as “incidental findings.” In accordance with well established medical guidelines, Invitae will consult with Healthspan and/or your healthcare provider when there are accepted medical interventions available and Healthspan and/or your healthcare provider can discuss these with you. There is a possibility that, if multiple family members are tested, this test may find that your family relationships are not what you believe them to be. Invitae will only report these findings if necessary to provide correct test results. It is your responsibility to consider the possible impact of your test results as they relate to insurance rates, obtaining disability or life insurance and employment.
How will you learn your results?
Invitae’s clinical reports are released to Healthspan. Clinical reports are confidential and will only be shared in accordance with applicable laws. Your clinical report is available for you to download from the Invitae patient portal (www.invitae.com/patients/signin) after it has been released to you by Healthspan or upon your request in accordance with the law.
Who can you speak to about your screening and results?
Healthspan and Invitae recommend that you consult with a genetic counselor or your healthcare provider before consenting to this screen. Healthspan and Invitae also recommend that you speak to a genetic counselor or your healthcare provider about your results.
Will your results ever change?
Knowledge of genetic information will improve over time, so new information may become available in the future that could impact the interpretation of your results. Invitae may notify you of clinical updates related to your genetic screen, in consultation with Healthspan or your healthcare provider. You may request additional notifications and resources relevant to your genetic screen by creating an Invitae patient portal account at www.invitae.com/patients/signin. This section describes how Invitae uses and protects your data and the choices available to you to determine how it is used. Two of Invitae’s founding principles are 1) patients own and control their own genetic information and 2) genetic information is more valuable when shared.
What types of data does Invitae use? As a genetic testing laboratory, Invitae receives your sample (e.g. blood, saliva) along with your relevant health information. Invitae then analyzes the genetic information contained within the sample and delivers a genetic test report to Healthspan. Your sample and the health and genetic information Invitae receives and generates about you (collectively, “your data”) is considered as sensitive personal data by regulators. Your data is subject to strict legal requirements regarding how it can and cannot be used and how it must be protected.
How does Invitae protect your data? Invitae takes robust measures to help keep your data safe and secure and limit use of your data only for permitted purposes. Invitae uses technical, administrative and physical safeguards to secure your data and protect it against misuse, loss, or alteration. Invitae also takes steps to de-identify or anonymize your data in accordance with applicable laws. De-identified data (also called pseudonymized data) is data that has been stripped of identifying information (such as your name or email address), although the data may contain a key that Invitae can use to link back to the individual where required. Anonymized data is similar to de-identified data except that there is no ability to link the data back to an individual.
How may your data be used or shared?
The following activities are a core part of Invitae’s genetic testing services such that when you consent to a genetic test, you are consenting to and understand you cannot opt out of these activities:
a. Providing genetic testing services, including preparing and delivering a genetic test report to Healthspan and/or your healthcare providers.
b. Performing operational activities in support of genetic testing services, such as billing for services Invitae provides. Invitae may contact you via text or email (per your contact preference) as part of delivering the genetic testing services.
c. Internal uses for validation, quality improvement, refining and updating Invitae’s classification of genetic variants, and product development related to genetic testing.
d. Sharing of anonymized variant information with ClinVar, a federal program that enables research on genes and health.
e. Sharing of data that is summarized at a group or aggregate level rather than data that is specific to a single individual.
f. Sharing of the contact information of Healthspan and your healthcare provider with third parties if your healthcare provider has provided consent.
You are also consenting to the research and commercial activities as set forth below, and you understand you can opt out of any of the following activities by setting your preferences in the Invitae patient portal or by emailing email@example.com:
a. Performing internal research activities. These are activities where Invitae uses patient samples or data to generate new knowledge.
b. Sharing de-identified data and samples with third parties for research or commercial activities. Third parties may include academic researchers, commercial entities, and other genetic testing laboratories. Recipients of the de-identified data and samples are prohibited from attempting to reidentify me. Recipients may link de-identified data from Invitae with other data sources to create a combined data set as long as the data remains de-identified. Invitae will NOT share your identifiable data or sample without your additional, explicit consent. If you opt out of data sharing after your data has already been shared, you understand your data cannot be “un-shared”. If you choose to participate in a sponsored testing program or other data sharing program offered by Invitae to help individuals access genetic testing, you are consenting to de-identified data sharing through the program. You understand that (1) you cannot opt out of data sharing through the program (except where required by law) and (2) your general data sharing preference will not apply to data sharing through the program.
c. Contacting you about research opportunities, opportunities to connect with others, product feedback, and new products and services.
What happens to your data if you are outside the United States?
Invitae is located in the United States and Invitae will process your data and sample in the United States.
How long may your data or sample be retained?
By agreeing to this form on the Healthspan Website, you confirm that: (1) you have read (or had read to me) and you understand the information provided in this consent; (2) you understand that genetic testing is voluntary, and you may choose not to have your sample tested; (3) you have received a copy of this consent form; (4) all your questions have been satisfactorily answered; and (5) you hereby consent to genetic testing and to the retention, use, and sharing of your data and sample as described in this form.