Stratify Genomics Prompt Prostate Genetic Score Test Informed Consent

Last modified October 1, 2018

Introduction

This consent form (“Consent”) reviews the benefits, risks and limitations of utilizing the Stratify Genomics, Inc. (“we”, “us” or “our”) Prompt Prostate Genetic Score test (“Prompt test”). It also explains how your information and biological sample will be used after performance of the Prompt test. Throughout this Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and sample is being provided for the Prompt test. Capitalized terms used but not defined in this Consent have the meaning given to them in our Terms of Service and Privacy Policy

Description of the Prompt Test

The Prompt test analyzes a panel of single nucleotide polymorphisms (SNPs), small changes in the DNA, to evaluate a man’s genetic predisposition to prostate cancer.

Benefits of the Prompt Test

Utilizing our Prompt test to discover your genetic risk for prostate cancer can help you gain a better perspective on your health. Your healthcare provider may use this information to help you make more informed health care decisions and choices.

Risks and Limitations of the Prompt Test

To utilize our Prompt test, a biological sample must be collected using a cheek swab. There are no risks associated with collecting a sample using this method or the collection materials in our Prompt test kit.

The Prompt test is a genetic screening test that may cause you to discover sensitive information about your health or disease risks. Once you obtain this information, the knowledge is irrevocable. You should not assume that any information we may be able to provide to you will be welcome.

The Prompt test is intended to detect genetic changes at selected SNPs known to be associated with a risk of developing prostate cancer. However, the Prompt test currently available cannot detect all genetic components of prostate cancer risk, as not all causes are known. Furthermore, the Prompt test does not account for the environmental aspects of prostate cancer risk.

The analysis of your Prompt test is based on currently available information. Future scientific research may change the interpretation of your results as the scientific community may show previous information to be incomplete or inaccurate. Stratify Genomics is not obligated to notify you if there is a new understanding of genetic research that might result in a change to the interpretation of your results.

Stratify Genomics has implemented several safeguards to avoid technical errors, but there is a chance that errors in genotyping may lead to an incorrect risk category: below average risk, average risk or above average risk which may impact healthcare practitioner screening efforts. Other sources of error include sample mix-up, poor sample quality or contamination, and technical errors in the laboratory.

Having an above average risk increases your risk of developing prostate cancer. Screening efforts on those men who are at greatest risk better informs patients of their individualized risk. However, this result does not necessarily mean that you have or will develop prostate cancer. Similarly, if you are found to have below average risk,

Stratify Genomics does not provide medical services, diagnosis, treatment, or advice. Our Prompt test and Services are not intended to be used for any diagnostic purpose and your results must be considered in the context of broader medical management; you should not make medical decisions without consulting your healthcare provider.

Special Considerations for Genetic Information

Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. If privacy or confidentiality is inadvertently broken, there is the risk of misuse. Such misuse could lead to adverse psychological effects or undesired effects on the ability of your or your family members to obtain a job or insurance. All information relating to the samples will be stored in a secured database. In addition, the results obtained from the samples will be stored in a secured database.

The Genetic Information Nondisclosure Act of 2008 (GINA) was enacted to protect against discrimination based on genetic information by employers and health insurance companies in the United States. However, GINA does not protect against discrimination by, for example, life insurance, long-term care insurance, or disability insurance providers. It may be considered fraud if you are asked by one of these kinds of providers whether you have learned genetic information about your health conditions and you do not disclose that you have had this Test.

Genetic information that you share with others could be used against your interests. Genetic information that is shared with your healthcare provider may become part of your medical record and through that route may be accessible to other healthcare providers and/or insurance companies in the future. Sharing genetic information that has limited or no meaning today may also be used against your interests as that information could have greater meaning in the future as new discoveries are made.

Retention and Use of Your Information

In order for the Prompt test to be performed as intended, you must provide us with accurate and correct information. If you are submitting information on behalf of another person, you represent and warrant that you are authorized to provide such information and that all such information is accurate and correct.

We are subject to multiple laws regarding the retention of data. Accordingly, we will retain any information collected for as long as we are required to maintain it under applicable laws and regulations, for regulatory and compliance purposes, for legal or business necessity, or where we otherwise reasonably believe that we have a legitimate reason to do so.

Your biological sample will be sent directly to our laboratory partner to conduct the Prompt test. Stratify Genomics has no obligations or liability regarding the retention of your sample. However, our laboratory partner may establish sample retention policies and maintain certain information to comply with applicable legal, regulatory and accreditation requirements.

Withdrawal of Consent

Your use of our Prompt test is voluntary. You may choose to withdraw your Consent or to stop using our Services at any time. You do not need to inform Stratify Genomics when you stop using our Services unless you are requesting closure of your Account. Such requests should be sent to us using the contact information below.

Contacting Stratify Genomics

If you have questions or comments about our Prompt test or this Consent, please contact us at: Stratify Genomics Inc., #891 3525 Del Mar Heights Rd. San Diego CA 92130/ 888.571.8810/ support@promptpgs.com

Legal Agreement and Consent

I agree that I have chosen to use the Prompt test and give my informed consent to have my biological sample Prompt tested. I give my permission for my information and results to be disclosed in accordance with this Consent, Terms of Service and the Privacy Policy. I understand that this Consent is a legally binding agreement and acknowledge that I have read, understood, and agree to the terms of this Consent.
I acknowledge that I am the individual whose sample will be Prompt tested and that I am a United States resident of at least 18 years of age, or that I have legal authority to consent on behalf of another United States resident of at least 18 years of age whose sample will be Prompt tested.

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