Prostate Cancer Genetic Risk Score Product Terms and Consent - updated March 15, 2019
We provide the prostate cancer GRS product to you under these Product Terms & Consent. When you agree to the Product Terms & Consent, you agree to the following:
Purpose of the Product(s)
The Prostate Cancer GRS is a population-standardized, genetic risk score offered to East Asian, non-Hispanic European, and African American males age 18 and older to evaluate their prostate cancer risk. The GRS is intended to provide you with information about how your genetics alter your risk for developing prostate cancer at some point in your life.
Due to advances in medical science, connections have been established between one’s genetics (DNA) and the likelihood of developing specific medical conditions, such as certain types of cancers and other diseases. Some variants in DNA (called “single nucleotide polymorphisms” or SNPs) are associated with specific diseases. The more risk-associated variants one has in his or her DNA, the more likely one is to develop prostate cancer .
Males who have a high prostate cancer GRS should contact their healthcare provider to learn more about ways to screen, prevent, diagnose, or treat prostate cancer. With increased knowledge of your genetic risk for prostate cancer, you and your doctors will be able to better address your medical needs, and you will be able to make more fully-informed decisions about your health.
The Prostate Cancer GRS cannot predict with 100% certainty if a particular person will develop prostate cancer. Instead, the GRS can inform some males if they are at higher risk than the general population for prostate cancer. For instance, the odds for males in the U.S. developing prostate cancer are 14% in the general population, but it can rise with an increase in prostate cancer associated SNPs. The reported range of the Prostate Cancer GRS is <0.1 and >6.
What to expect from the Prostate Cancer GRS Product
In order to use the NorthShore Prostate Cancer GRS, you must first register with Helix. As part of that registration you will also complete a health history questionnaire. Upon completion, Helix will notify NorthShore University HealthSystem (“NorthShore” or “Us” or “We”) of your request for interpretation and Helix will send Us your health history answers pursuant to your authorization.
We will then share information about you (such as your name, date of birth, gender) with Genome Medical Services, P.C. (“Genome Medical”). Genome Medical is a nationwide specialty medical practice that is solely dedicated to genomic medicine. A physician affiliated with Genome Medical will determine whether it is appropriate for you to obtain the GRS interpretation. As part of this determination Genome Medical may contact you. Once Genome Medical has approved this test for you, you will be notified and upon completion of your sequencing, Helix will share your Product Genetic Information with Us.
On average, NorthShore will provide your Prostate Cancer GRS within 2 weeks of receipt of your sequencing information from Helix (typically 4-8 weeks). Upon completion of the interpretation, NorthShore will send your GRS to Genome Medical, which will share it with you. If you are found to have an elevated GRS, Genome Medical will be available to help you understand your results and what it means for you and your family.
If you are not found to have an elevated GRS, you may still choose to contact a genetic counselor, particularly if you have a personal or family history of prostate cancer, to discuss other cancer-risk screening recommendations.
You may also want to share your results with your healthcare provider, and in some cases your results may require follow up with a prostate cancer specialist or other specialist.
What You May Learn
This product provides your risk score and remaining lifetime risk at your current age:
You may learn that you have an increased risk of developing prostate cancer. This information may enable you to increase prostate cancer screening or start prostate cancer screenings at an earlier age. Your insurance may or may not cover these interventions.
Limitations of this Product
More than 160 prostate cancer risk-associated SNPs have been identified using genome wide association studies (GWAS) in multiple populations. The prostate cancer GRS checks the most common risk-associated SNPs (variants) linked to prostate cancer. However, it does not check all genes associated with prostate cancer. Certain variants in high penetrance genes (HPGs), also called major susceptibility genes, are also associated with prostate cancer. One example of HPGs is BRCA2.Through the Helix and NorthShore GRS test, HPG testing is not currently offered due to limitations with the current technology available at NorthShore. A comprehensive genetic test including GRS and HPGs is recommended if there is family history of prostate cancer. The GRS does not take into account other factors that may influence prostate cancer risk, including family history, environmental and lifestyle factors, and other currently unknown factors.
This product uses SNPs that have primarily been studied in non-Hispanic European, African American, and East Asian populations. As such, results for customers from other backgrounds may not be as accurate.
Genetics is a field that is evolving quickly. Scientists are always discovering new details about how to interpret DNA data. They are also learning that some previous discoveries are not valid. The Prostate Cancer GRS is based on the current state of knowledge. As our knowledge improves, the insights relating to your GRS may change and your GRS may offer new insights based on the same genetic information.
The GRS is only a risk assessment tool; it is not a diagnostic tool. The GRS can help identify prostate cancer risk, but it does not predict with 100% certainty whether an individual will develop prostate cancer.
You may learn something that you did not want to know. In some cases, someone may learn that one or both of their parents are not biologically related to them. This may happen due to adoption or non-paternity/non-maternity. You may also learn that your parents are biologically related to each other, such as in cases where the parents are cousins. You may learn that your ancestry differs from what you may have expected, or you may learn about an unexpected risk for a health condition. There may be risks that are not known at this time. You may want to discuss your options with your doctor, a mental health professional, or a genetic counselor before or after you get your results.
When sending data over the internet and maintaining data, security cannot be guaranteed. In obtaining a prostate cancer GRS, there is a risk of a security incident impacting your health information or genetic information. In such an event, someone could access information we have about you. This could include your raw sequencing data, your date of birth, address or other personal information. The privacy and security of your medical and genetic information is of utmost importance to NorthShore and Genome Medical, and we constantly review our security practices to ensure that your data is maintained as securely as possible. No system, however, can perfectly guard against risks of intentional intrusion or inadvertent disclosure of information sent to Us.
Under the Genetic Information Nondiscrimination Act (GINA), if you work for a company of 15 or more people, your employer may not ask you about your Genetic Information. They are also barred from using any Genetic Information in hiring or other employment decisions. Your health insurer cannot use genetic testing information in decisions about coverage and health premiums.
This restriction only applies to employment and health insurance companies. For example, companies that offer life, long-term care, or disability insurance are not covered by GINA. Neither are the US Armed Forces. Some states have safeguards on top of the safeguards in GINA. You should be aware of the laws in your state and be careful with whom you choose to share your Genetic Information.
For your family:
This test looks at several dozen prostate cancer risk-related SNPs. Each of these SNPs might be passed on to a future generation. Since, the genetic risk score is truly a personalized score and is calculated based on the combined effect of the SNPs you have, your family member’s genetic risk score may be different than yours, based on the SNPs they have. This means that a high risk score for one person does NOT mean other family members will be in the same risk category. If one relative is in the 'average risk' category, there is a chance that other relatives could be in the 'high risk' category. That means each of your male relatives should have his own test to understand his genetic risk score and chance of developing prostate cancer.
Use of your data
To get the prostate cancer GRS product, you must let Helix share your Product Genetic Information with Us. You must also let Helix share the answers to your health history questionnaire with Us. You must then let us share those answers with Genome Medical.
We may choose to perform research that may be published in academic journals. We will only use your data for such research if you give us your separate consent. We will ask for that consent through our Research Consent. The Research Consent will have been approved by an Institutional Review Board (IRB). You can choose to decline taking part in this research. Your choice will not affect any services or opportunities you may otherwise be entitled to.
Data deletion and/or cancellation
We adhere to Clinical Laboratory Improvement Amendments (CLIA) standards for data management and storage, including the requirement to store all test results for 10 years. After the ten-year period, you may contact us at 847.570.2000 to request data deletion.
To have Helix stop sharing your information with Us, contact Helix’s Customer Care.
If you have questions, please contact us at firstname.lastname@example.org or (224) 364-7696.
US Preventive Services Task Force, et al., Screening for Prostate Cancer: US Preventive Services Task Force Recommendation Statement. JAMA 319, 1901-1913 (2018)
American Academic of Family Physicians, et al., Prostate Cancer: Clinical Preventative Service Recommendation. https://www.aafp.org/patient-care/clinical- recommendations/all/prostate-cancer.html.
American Urological Association, et al., Prostate Cancer: Early Detection (2013; reviewed for currency 2018). https://www.auanet.org/guidelines/prostate-cancer-early-detection-(2013-reviewed-for-currency-2018)