Patient Informed Consent (Preconception Screens)

on Evolve Pre-Conception genetic screens

1. INTRODUCTION

This Informed Consent describes the benefits, risks, and limitations of our various genetic Pre-Conception screens: 1) Carrier Screens (Evolve FamilyReady Genetic Carrier Screen, 2) Fertility Genetic Screens (Evolve Female Fertility Screen, Evolve Premature Ovarian Failure Screen, and Evolve Male Fertility Screen), each of which is described in greater detail below. All of our screens are voluntary. You should seek genetic counseling prior to undergoing any of our screens. Genetic counseling is made available to patients through www.evolvegene.com. Prior to undergoing genetic screening, you are encouraged to visit the EvolveGene website for more information regarding the scope and extent of counseling services and support available through EvolveGene, as well as terms and conditions of its screening service. Please read this form and our website carefully before making your decision about screening.

2. INFORMATION REGARDING SPECIFIC SCREENS

CARRIER SCREENS

FAMILY READY GENETIC CARRIER SCREEN: We recommend the Evolve FamilyReady Carrier Screen for anyone thinking of having a child. This screen detects carrier status for 138 autosomal recessive disorders and 10 x-linked disorders. A full list of the conditions and diseases that may be detected by this screen can be provided upon request.

Uses of Carrier Screens

You may use the information derived from these screens to inform your decisions in preparing for a family. It allows you and your partner, prior to pregnancy, to assess your risk of having a child who may have a genetic disorder and, therefore, to make more informed decisions regarding your family. Results may also benefit other family members. If you test positive for a disorder, your biological relatives are more likely to test positive for the same mutation(s), and, therefore, your results can reveal potential risks of other family members as well. Mutations often differ from one population to another. You should share information about your family history and ethnic background, as well as that of your partner, in order to assist us in interpreting your screening results. If you have a family history of one of the conditions on the EvolveGene panel, you should inform us of the specific gene mutations(s) present in your family.

How the Carrier Screens Work

Carrier screens are done on a sample of your blood or saliva. They analyze specific changes in your DNA called mutations. For most of the conditions for which we screen, both parents must carry a mutation in the same disease gene in order for their child to be at risk of being affected. Such conditions are said to be inherited in an “autosomal recessive” manner. There are a few diseases, however, for which we screen that require only one parent to carry the mutation in order to be passed on the child. We refer to such conditions as “X-linked disorders.” Fragile X is an example of such condition.

Notification of Screening Results

You and/or your health care provider will be notified when the results of your screen are available. Your healthcare provider is responsible for interpreting the screening results and explaining the significance of those results to you. You may also contact us about counseling services provided by EvolveGene directly to patients.

What Do The Results Mean?

A positive result tells you that a gene mutation has been identified, and that you are a carrier of a particular disorder or disorders. If you receive a positive result, you may wish to consult with your healthcare provider, pursue genetic counseling and/or have your partner undergo genetic screening. Most individuals who are carriers of such genetic mutations have no symptoms of genetic disorders themselves, but if their partners are carriers of the same genetic mutation, the couple is at risk of passing on a disease to their offspring. If both parents are carriers of the same genetic disease, there is a 1 in 4, or 25%, chance that the disorder will be passed on to one or more of their children. If one parent is a carrier, the child will have a 50% chance of being a carrier as well but will have a much lower risk of actually having the condition or disease.

A negative result indicates that no gene mutation was identified. This reduces but does not eliminate the risk for being a carrier. An indeterminate result indicates that we cannot report a positive or negative result with confidence, using stringent quality-control guidelines.

WE RECOMMEND THAT NO IRREVERSIBLE CLINICAL DECISIONS BE MADE BASED ON THESE SCREENING RESULTS ALONE. CONSULT YOUR HEALTHCARE PROVIDER FOR MORE INFORMATION ABOUT THE LIMITATIONS OF THIS SCREEN, INCLUDING ERROR RATES (FALSE POSITIVES AND FALSE NEGATIVES). GENETIC COUNSELING BEFORE AND AFTER SCREENING IS RECOMMENDED AND AVAILABLE THROUGH EVOLVEGENE.

RISKS AND LIMITATIONS OF CARRIER SCREENS

Results Are Not Diagnostic

SCREENING RESULTS ARE NOT INTENDED OR DESIGNED TO BE USED TO DIAGNOSE, PREVENT OR TREAT ANY CONDITION OR DISEASE OR TO DETERMINE THE STATE OF YOUR HEALTH. EVOLVEGENE IS NOT A MEDICAL PROVIDER, AND ANY INFORMATION OR SERVICES PROVIDED BY EVOLVEGENE DO NOT CONSTITUTE MEDICAL OR OTHER HEALTHCARE ADVICE. YOU SHOULD NOT RELY EXCLUSIVELY ON ANY INFORMATION ON OUR WEBSITE SITE OR ANY SCREENING RESULTS RECEIVED FROM US OR ANY GENETIC COUNSELING PROVIDED BY US AS PROFESSIONAL MEDICAL ADVICE. YOU SHOULD SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL WITH ANY QUESTIONS YOU MAY HAVE REGARDING THE CURE, TREATMENT, MITIGATION OR PREVENTION OF ANY DISEASE OR OTHER MEDICAL CONDITION AND BEFORE BEGINNING OR MODIFYING ANY TREATMENT OR MEDICATION. A PHYSICIAN’S ORDER MAY BE NECESSARY FOR SOME OF OUR SERVICES.

Accuracy and Meaning of Results

Although our carrier screens are highly accurate for targeted mutations, no is not 100% accurate or predictive. First, screens only look for specific chromosomal abnormalities. Not every gene is analyzed, and it is not possible to identify every mutation associated with each disease or condition. This means that other chromosomal abnormalities may be present and could cause health concerns. Our screens do not test your health. A normal result does not guarantee that you or your offspring will be free of all genetic disorders.

False Positives and Negatives

Like many screens, our carrier screens have limitations, including the possibility of false positive and false negative results. This means that the chromosomal abnormality being screened for may be present even if you receive a negative result (this is called a “false negative”)l or that you may receive a positive result for the chromosomal abnormality being screened for, even though it was not really present (this is called a “false positive”).

Other Factors That May Affect Accuracy

The accuracy of carrier screening results may be further limited by certain biological factors, such as a history of bone marrow transplantation or recent blood transfusions. The interpretation of results is based on currently available scientific information and knowledge, which is constantly being updated. We do not routinely re-analyze screening results or issue new screening result reports and are not obligated to do so.

FERTILITY SCREENS

FEMALE GENETIC FERTILITY SCREEN: We recommend the Evolve Female Genetic Fertility Screen to any woman who has experienced infertility. Evolve Female Fertility Screen detects the most common genetic causes of female infertility. The screen provides mosaic chromosomal analysis as well as analysis of six genes associated with major female infertility issues including dysfunctional sexual development, which impacts ovarian function and health.

PREMATURE OVARIAN FAILURE SCREEN: We recommend the Evolve Premature Ovarian Failure Screen to any woman who has experienced infertility issues, especially with a personal or family history of ovarian insufficiency. Evolve Premature Ovarian Failure Screen reveals if a female has diminished ovarian reserves due to genetic contributions that lead to premature ovarian failure (POF). The screen detects FMR1 genetic permutations, which account for a significant proportion of POF cases, and in addition analyzes 20 genes known to be associated with low or poor reserves of eggs in females.

MALE GENETIC FERTILITY SCREEN: We recommend the Evolve Male Genetic Fertility Screen to any male partner in a couple that has experienced infertility. The screen detects genetic causes of sperm abnormalities and dysfunctional sexual development through mosaic chromosomal analysis, sex chromosome aneuploidy analysis, Y-chromosome deletion analysis, and accurate mutation analysis of five genes known to be associated with male infertility, including targeted mutation analysis of 39 cystic fibrosis transmembrane conductance regulator (CFTR) mutations.

Uses of Fertility Screens

Evolve fertility screens benefit males and females with a suspected genetic cause of infertility. Infertility is the failure to conceive after a couple has attempted to become pregnant for at least 12 months. Genetic causes of female infertility decrease the chance for a women to become pregnant. An estimated 10% of females with infertility have a genetic anomaly. Premature ovarian aging is one of the most common causes of female infertility, and it is a condition associated with a low or poor reserve of eggs relative to what is expected at any given age. The Fragile X (FMR1) permutation is one of the most significant risk factors for premature ovarian aging and female infertility in general. The FMR1 permutation is also surprisingly common in the general population, with a prevalence of approximately 1 in 150 females.

Genetic anomalies also constitute a significant risk factor for male infertility. Y microdeletions account for 15% of all male infertility, and chromosomal mosaicism accounts for 5-10% of all male infertility. Sex chromosome aneuploidies (i.e. Klinefelter Syndrome), genetic anomalies, such as numerical and structural chromosomal abnormalities, and genetic mutations, such as CFTR mutations have also been detected in males with unexplained azoospermia and oligospermia. Results may also benefit other family members. If you test positive for a mutation such as in the CFTR gene (as part of the male fertility panel), your biological relatives are more likely to test positive for the same mutation(s), and, therefore, your results can reveal potential risks of other family members as well. Mutations often differ from one population to another. You should share information about your family history and ethnic background, as well as that of your partner, in order to assist us in interpreting your test results. If you have a family history of one of the conditions on the Evolvegene panel, you should inform us of the specific gene mutations(s) present in your family.

How the Fertility Screens Work

Both male and female fertility screens are done on a sample of your blood. The male fertility screens involve analysis of specific mutations of genes known to be associated with male infertility, mosaic chromosome analysis and deletion analysis of the Y chromosome. The female fertility screen and premature ovarian aging screen both involve analysis of specific mutations of genes known to be associated with female infertility, mosaic chromosome analysis and FMR1 trinucleotide (CGG) repeat length analysis.

Notification of Screening Results

You and/or your health care provider will be notified when the results of your screen are available. Your healthcare provider is responsible for interpreting the screening results and explaining the significance of those results to you. You may also contact us about counseling services provided by EvolveGene directly to patients.

What Do The Results Mean?

A positive result tells you that either gene mutation or chromosomal abnormality has been identified.. If you receive a positive result, you may wish to consult with your healthcare provider and pursue genetic counseling

A negative result indicates that no gene mutation or chromosomal abnormality was identified. . An indeterminate result indicates that we cannot report a positive or negative result with confidence, using stringent quality-control guidelines.

WE RECOMMEND THAT NO IRREVERSIBLE CLINICAL DECISIONS BE MADE BASED ON THESE SCREENING RESULTS ALONE. CONSULT YOUR HEALTHCARE PROVIDER FOR MORE INFORMATION ABOUT THE LIMITATIONS OF THIS SCREEN, INCLUDING ERROR RATES (FALSE POSITIVES AND FALSE NEGATIVES). GENETIC COUNSELING BEFORE AND AFTER SCREENING IS RECOMMENDED AND AVAILABLE THROUGH EVOLVEGENE.

RISKS AND LIMITATIONS OF FERTILITY SCREENS

Results Are Not Diagnostic

SCREENING RESULTS ARE NOT INTENDED OR DESIGNED TO BE USED TO DIAGNOSE, PREVENT OR TREAT ANY CONDITION OR DISEASE OR TO DETERMINE THE STATE OF YOUR HEALTH. EVOLVEGENE IS NOT A MEDICAL PROVIDER, AND ANY INFORMATION OR SERVICES PROVIDED BY EVOLVEGENE DO NOT CONSTITUTE MEDICAL OR OTHER HEALTHCARE ADVICE. YOU SHOULD NOT RELY EXCLUSIVELY ON ANY INFORMATION ON OUR WEBSITE SITE OR ANY SCREENING RESULTS RECEIVED FROM US OR ANY GENETIC COUNSELING PROVIDED BY US AS PROFESSIONAL MEDICAL ADVICE. YOU SHOULD SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL WITH ANY QUESTIONS YOU MAY HAVE REGARDING THE CURE, TREATMENT, MITIGATION OR PREVENTION OF ANY DISEASE OR OTHER MEDICAL CONDITION AND BEFORE BEGINNING OR MODIFYING ANY TREATMENT OR MEDICATION. A PHYSICIAN’S ORDER MAY BE NECESSARY FOR SOME OF OUR SERVICES.

Accuracy and Meaning of Results

Although our carrier screens are highly accurate for targeted mutations, no is not 100% accurate or predictive. First, screens only look for specific genetic mutations and chromosomal abnormalities. Not every gene is analyzed, and it is not possible to identify every mutation associated with each disease or condition. This means that other genetic mutations or chromosomal abnormalities may be present and could cause health concerns. Our screens do not test your health. A normal result does not guarantee that you or your offspring will be free of all genetic disorders.

False Positives and Negatives

Like many screens, our carrier screens have limitations, including the possibility of false positive and false negative results. This means that the genetic mutation or chromosomal abnormality being screened for may be present even if you receive a negative result (this is called a “false negative”)l or that you may receive a positive result for the chromosomal abnormality being screened for, even though it was not really present (this is called a “false positive”).

Other Factors That May Affect Accuracy

The accuracy of fertility screening results may be further limited by certain biological factors, such as a history of bone marrow transplantation or recent blood transfusions. Infertility may also be caused by one of or any number of biological, physiological, anatomical, idiopathic or other known or unknown genetic factors. These screens only investigate a subset of possible genetic abnormalities associated with male infertility, female infertility and female premature ovarian aging. The interpretation of results is based on currently available scientific information and knowledge, which is constantly being updated. We do not routinely re-analyze test results or issue new screening result reports and are not obligated to do so.

3. GENERAL RISKS ASSOCIATED WITH SCREENS

Non-Medical Risks

These screening services will require the physical transport of a screen kit containing your blood or saliva samples to an independent offsite laboratory. Mindful efforts have gone into the design of the packaging and selection of the shipping service used to transport your screen kit to the laboratory site. However, whenever such medical transportation is undertaken, circumstances may occur, such as temperature changes, delivery delays, shipper negligence and packaging damage that could alter or impact the accuracy, functionality or ability to complete the screen. EVOLVEGENE SHALL NOT BE RESPONSIBLE OR LIABLE FOR ANY NONMEDICAL ERRORS OR OMISSIONS OR DAMAGES ARISING FROM OR RELATED TO THE MANUFACTURING OF YOUR SCREEN KIT OR THE SHIPPING, HANDLING, POSSESSION, OR ORGANIZATIONAL MANAGEMENT OF YOUR SCREEN KIT OR SAMPLE BY ANY OTHER PERSON OR ENTITY, INCLUDING, WITHOUT LIMITATION, ANY SUCH ERRORS, OMISSIONS OR DAMAGES THAT MAY RESULT IN YOUR SAMPLE BEING SUBMITTED TO ANY DESIGNATED INDEPENDENT LABORATORY IN AN UNSAFE OR UNSTABLE CONDITION. THE NONMEDICAL ERRORS, OMISSIONS OR DAMAGES FOR WHICH EVOLVEGENE SHALL NOT BE RESPONSIBLE OR LIABLE HEREUNDER INCLUDE, WITHOUT LIMITATION, THOSE ARISING OUT OF ANY OTHER PERSON’S OR ENTITY’S NEGLIGENCE, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

Discrimination Risks

Genetic information could be used as a basis of discrimination. To address concerns regarding possible health insurance and employment discrimination, some countries, U.S. states and the U.S. government have enacted laws (e.g., the Genetic Nondiscrimination Act) to prohibit genetic discrimination by employers and health insurance carriers on the basis of genetic information. These laws, however, may not protect against genetic discrimination in other circumstances, such as when applying for life insurance or long-term disability insurance. Talk to your healthcare provider or genetic counselor if you have concerns about genetic discrimination prior to screening. BY AGREEING TO THIS INFORMED CONSENT, YOU ACKNOWLEDGE AND UNDERSTAND THAT SCREENING RESULTS MAY BECOME PART OF YOUR MEDICAL RECORD, WHERE THEY CAN BE MADE AVAILABLE TO INDIVIDUALS OR ORGANIZATIONS WITH LEGAL ACCESS TO SUCH MEDICAL RECORD, INCLUDING, WITHOUT LIMITATION, PHYSICIANS AND NURSING STAFF DIRECTLY INVOLVED IN YOUR CARE, YOUR CURRENT AND FUTURE INSURANCE CARRIERS AND OTHERS SPECIFICALLY AUTHORIZED BY YOU TO GAIN ACCESS TO YOUR MEDICAL RECORDS OR TO WHOM YOU HAVE AUTHORIZED US TO RELEASE YOUR RESULTS.

Incidental Findings

In the course of performing the analysis for the indicated screens, information regarding other chromosomal alterations may become evident (called Incidental Findings). For example, genetic screening may reveal sensitive information about your own health or that of your relatives, or other incidental, unsought information, such as discovering that a man is not the father of a child. Our policy is to NOT REPORT on any Incidental Findings that may be noted in the course of analyzing the screening data.

Recommendation to Consult Healthcare Professional

CONSULT YOUR HEALTHCARE PROVIDER FOR MORE INFORMATION ABOUT THIS SCREEN, INCLUDING THE LIMITATIONS AND RISKS OF THIS SCREEN, PERFORMANCE DATA, AND ERROR RATES, DESCRIPTIONS OF THE COMMON ANEUPLOIDIES AND SEX CHROMOSOME ANEUPLOIDIES, AND WHAT THE SCREENING RESULTS MAY MEAN TO YOU. BY UNDERGOING THIS SCREEN, YOU ACKNOWLEDGE THAT YOUR HEALTHCARE PROVIDER HAS DETERMINED THAT THIS SCREEN IS APPROPRIATE FOR YOU.

4. PRIVACY AND SECURITY OF YOUR PERSONAL INFORMATION AND RESULTS

How May We Use and Share Your Information?

The confidentiality and security of the information you provide to us and your screening results are critically important to us. We will keep your screening results confidential and will only release them in connection with the screening service to your healthcare provider, his or her designee, other healthcare providers involved in your medical care, or to another healthcare provider or person as directed by you (or a person legally authorized to act on your behalf) in writing, except as otherwise provided herein.

Generally, speaking, we may use and share your information as we do the following:

A. Treat you: We may use your health information and share it with other professionals treating you, e.g., we may share your genetic testing results with your doctor.

B. Run our organization: We may use and share your health information to run our practice, improve your care and contact you when necessary, e.g., we use your health information to manage your treatment and services, provide customer service when you have questions about your results, or to develop new screenings and other services.

C. Bill for your services: We may use and share your health information to bill and receive payment from health plans or other entities, as applicable.

D. Help with public health and safety issues: We may be allowed or required to share your information in other ways that contribute to the public good, such as public health and research, e.g., for the purpose of preventing disease, helping with product recalls, reporting adverse reactions to medications, reporting suspected abuse, neglect or domestic violence, or preventing or reducing serious threats to a person’s health or safety. Before we may do so, however, we need to meet many legal conditions. For more information, see the HHS Guidance Materials (https://www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html).

E. Do research: We may use or share your information for health research, as authorized in Section 9 of this Informed Consent.

F. Comply with health oversight audits or inspections: We may use or share your information to comply with audits or inspections by the Department of Health and Human Services to show that we are complying with federal privacy laws.

G. Comply with the law: If we reasonably believe that sharing your information is necessary to comply with a law, regulation or legal process, we will share it, but we will make our best efforts to give you written notice in advance of such disclosure, unless prohibited by law or court order.

H. Respond to organ and tissue donation requests: We may share health information about you with organ procurement organizations.

I. Work with a medical examiner or funeral director: We may share health information with a coroner, medical examiner or funeral director when an individual dies.

J. Address workers’ compensation, law enforcement or other government requests: We may use or share health information about you for workers’ compensation claims, for law enforcement purposes or with law enforcement officials, with health oversight agencies for activities authorized by law, or for special governmental functions, such as military, national security, and presidential protective services.

K. Respond to lawsuits and legal actions: We may share health information about you in response to a court or administrative order or in response to a subpoena.

We may only disclose your personal information without your consent in the following limited circumstances:

A. To third party vendors with which we contract to provide services that are necessary to our website or with designated independent laboratories who will analyze your samples, to the extent the release of such information is necessary for their analysis. Such vendors and laboratories are contractually or, in some cases, legally required to protect the information we share with them and may only use such information for that purpose; or

B. We may disclose information we maintain if (1) we believe, in good faith, that doing so is reasonably necessary to comply with the law or legal process or to comply with a legal duty to inform others; (2) to protect and defend our rights and property; (3) to address fraud, security or spam in order to protect against the misuse or unauthorized use of our website; (4) to protect the personal safety, property, or rights of our users or the public, including, without limitation, as we believe that it is necessary to prevent imminent and serious bodily harm to a person, or (4) in connection with a corporate transaction, such as a merger, consolidation, divestiture or asset sale.

If we are going to release your information in these circumstances, we will use our best efforts to provide you with notice in advance of such release, unless we are prohibited by law or court order from doing so. We will never sell your personal information.

When your sample is submitted to us, you agree that we may use the information you provide, as we describe in this notice. If we need to share your information for other purposes, we will ask for your written or electronic authorization, which you may later revoke by notifying us in writing of your desire to do so. We will inform you promptly if a breach occurs that may have compromised your privacy or the security of your information.

Digital Security and HIPAA Compliance of Our Cloud-Based Environment (“Cloud”)

In all circumstances, we take your personal information seriously and maintain rigorous technical and organizational protections to prevent the unauthorized disclosure or access to your information. EvolvGene employs a range of physical, technical and administrative safeguards to secure the information you entrust to us and protect it from loss, misuse and unauthorized access, disclosure, alteration or destruction. Information you provide to EvolveGene through our website is encrypted using industry standard Secure Socket Layer (SSL) technology, and your protected health information is processed and stored in a Cloud behind firewalls on controlled servers with restricted access. In addition, EvolveGene limits our employees’ and contractors’ access to your protected health information. Only properly authorized employees and contractors with a valid purpose for accessing your information have such access. Our information security governance is in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and also meets the requirements and guidelines of the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP). We do not store any credit card information, and we are compliant with PCI data security standards.

You understand and agree that you also play a crucial role in protecting your own personal information. When registering on our website, you should choose a password of sufficient length and complexity. You should not share your password to any third parties, and you should notify us immediately if you become aware of any unauthorized access to your account. We will never ask you for your password in an unsolicited call or an unsolicited email. We may ask you to confirm personal identifiers when registering an account or requesting support, which we use in conjunction with other security measures, such as email verification, to confirm your identity and safeguard your personal information.

HOWEVER, YOU ACKNOWLEDGE THAT SECURITY SAFEGUARDS, BY THEIR NATURE, ARE CAPABLE OF CIRCUMVENTION, AND EVOLVEGENE DOES NOT AND CANNOT GUARANTEE THAT PERSONALLY IDENTIFIABLE INFORMATION ABHOUT YOU WILL NOT BE ACCESSED BY UNAUTHORIZED PERSONS CAPABLE OF OVERCOMING SUCH SAFEGUARDS (I.E., HACKERS), WHO MAY USE VIRUSES, WORMS, TROJAN HORSES AND OTHER UNDESIRABLE DATA AND SOFTWARE TO OBTAIN ACCESS TO OR DAMAGE OUR SITE.

YOU AGREE THAT EVOLVEGENE IS NOT LIABLE FOR THE UNAUTHORIZED RELEASE OF YOUR RESULTS OR MEDICAL INFORMATION, UNLESS SUCH UNAUTHORIZED RELEASE WAS THE RESULT OF GROSS NEGLIGENCE OR WILLFUL MISCONDUCT ON THE PART OF EVOLVEGENE. YOU ACKNOWLEDGE THAT CERTAIN E-MAIL, SMS, TELEPHONE OR VIDEO COMMUNICATIONS MAY NOT BE ENCRYPTED AND/OR SECURE, AND, UNLESS YOU REQUEST THAT EVOLVEGENE NOT CONTACT YOU BY THOSE MEANS, THERE ARE RISKS ASSOCIATED WITH SUCH UNSECURED COMMUNICATIONS.

Your Rights Concerning Your Health Information and Medical Record

You have the rights listed below regarding your health information and medical record:

A. To receive a paper or electronic copy of your health information: You may ask us to see or receive a paper or electronic copy of your medical record and other health information we have about you. We will provide such copy to you, usually within 30 days of your request, and we may charge a reasonable, cost-based fee.

B. Correct your paper or electronic medical record: You may ask us to correct health information about you that you think is incorrect or incomplete. If we disagree with the proposed correction, we may deny your request, but we will provide you a written explanation for doing so within 60 days.

C. Request confidential communications: You may ask us to contact you in a specific way (for example, by calling a specific number or sending mail to specific address). We will accommodate all reasonable requests.

D. Ask us to limit what information we share: You may ask us not to use or share certain health information for treatment, payment, or other internal operations. We are not required to agree to your request, and we may say “no” if it would affect your care or our ability to be paid for the services we provide you. If you pay for our services, or any particular services or items from us, out of your own pocket, you can ask us not to share your information with your health insurer. We will accommodate that request unless a law requires us to share that information. If you prefer not to have any health information used about you in research, you may request this by contacting our client services.

E. Get a list of those with whom we have shared your information: You can ask for a list (also known as an “accounting”) of the times we have shared your health information for six years prior to the date you ask, persons and entities with whom we shared such information and why. We will include all the disclosures except for those about treatment, payment, and health care operations, and certain other disclosures (such as any you asked us to make). We will provide one free accounting per year but will charge a reasonable, cost-based fee if you ask for another one within 12 months.

F. Get a copy of this privacy notice: You may ask for a paper copy of this notice at any time, even if you have agreed to receive the notice electronically, and we will promptly provide you a paper copy.

G. Choose someone to act for you: If you have given someone medical power of attorney, or if someone is your legal guardian, that person can exercise your rights and make choices about your health information. We will verify that the person has this authority and may act for you before we take any action.

H. File a complaint if you believe your privacy rights have been violated: If you are concerned that we have violated your privacy rights, you may contact us by e-mail at Support@EvolveGene.com or by telephone in the United States or Canada by dialing 1-800-963-3203 or outside of the United States or Canada by dialing 001-519-763-2720. If you are not satisfied with our response, you may file a written complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 877-696-6775, or visiting the HHS website (https://www.hhs.gov/ocr/privacy/hipaa/complaints/). We will not retaliate against you for filing a complaint.

5. USE OF INFORMATION AND LEFTOVER SPECIMENS

Storage of Leftover Specimens

Pursuant to best practices and clinical laboratory standards, leftover, de-identified specimens (unless prohibited by law), as well as de-identified genetic and other information learned from your screening, may be used by EvolveGene or by the designated independent laboratory that analyzes your sample, or by others on their behalf for purposes of quality control, laboratory operations, laboratory screen development, and laboratory improvement. All such uses will be in compliance with applicable law. Leftover specimens from New York State will be destroyed within 60 days.

Research

We may use your leftover specimen and your health information, including genetic information, in an anonymized or de-identified form (unless otherwise allowed by applicable law) for research purposes. All such uses will be in compliance with applicable law. This does not apply to leftover specimens collected from New York State.

Such uses may result in the development of inventions, discoveries, commercial products, screens or services. You acknowledge that EvolveGene owns and all intellectual property rights that may result from the use of your de-identified sample or genetic information. You will not receive notice of, nor will any compensation be paid to you due to inventions, new products, screens or discoveries resulting from any research or development using your de-identified sample.

6. NOTICE TO INTERNATIONAL USERS

Genetic screening services provided by EvolveGene and/or any of our designated independent laboratories, as well as any genetic counseling services provided by EvolveGene and any information provided by us on our website or collected by us from any patient are governed by and in accordance with the laws of the United States of America, the State of Florida and the states in which any of our designated independent laboratories are located. We make no representation as to the compliance of any such services or information with the laws of any other jurisdiction. If you are located or gaining access to our website or any of our services outside the United States, you acknowledge and agree that your access and use of our website and any services provided by us or by any of our designated independent laboratories is in compliance with the laws of the jurisdiction where you are located or from which you have gained access to our website or any of such services, including, without limitation, all laws regarding online conduct and acceptable content, data storage, export controls and import laws, or any laws governing the provision of blood or saliva samples or genetic screening or counseling. It is your responsibility to notify us if the storage of your data in the United States is prohibited by your local law.

The software, technology and other information made available through our website are further subject to the United States export controls and, potentially, the import laws of jurisdictions outside the United States. No software, technology or other information from our website may be downloaded or otherwise exported or re-exported to any person or entity on the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Commerce Department’s Table of Denial Orders or otherwise prohibited by United States export control laws. By downloading or otherwise using any software, technology or other information from our website in any manner whatsoever, you represent and warrant that you are not on any such list or located in, under the control of, or a national or resident of, any such country.

YOU FURTHER ACKNOWLEDGE AND AGREE THAT EVOLVEGENE SHALL NOT BE RESPONSIBLE OR LIABLE FOR THE VIOLATION OF THE LAWS OF ANY JURISDICTION OUTSIDE THE UNITED STATES DUE TO YOUR ACCESS OR USE OF OUR WEBSITE OR ANY OF OUR SERVICES.

7. LEGAL AGREEMENT / DISPUTE RESOLUTION

Agreement Regarding Screening and Disclosure

By consenting to undergo our screening, you hereby give permission to EvolveGene, its contractors and assignees to perform genetic screening on the sample you provided and to disclose the results of the screening to your ordering physician and any other person you have designated. You acknowledge that you are not an insurance company or an employer attempting to obtain information about an insured person or employee.

Governing Law

This consent shall be governed by the laws of the United States of America and the State of Florida, without regard to its conflicts of laws principles. All lab screen kits are processed at our designated independent laboratories in accordance with the laws of the states in which such laboratories are located. Each of our designated independent laboratories is licensed in the state in which it is located.

Disputes to Be Resolved By Binding Arbitration

You acknowledge and agree that any disputes, claims or controversies between you and EvolveGene relating to any services provided, not provided or to be provided by EvolveGene, whether in tort (intentional or negligent), contract or otherwise, including, without limitation, any dispute, claim or controversy regarding whether any services provided hereunder were improperly, negligently or incompetently rendered, or claims for wrongful death, discrimination, emotional distress or punitive damages, will be determined by submission to binding arbitration, as provided by Florida law. Such arbitration shall take place in Saint Petersburg, Florida.

By your agreeing to the terms hereunder, you acknowledge that both EvolveGene and you are giving up our constitutional right to have any such dispute decided in a court of law before a jury instead of accepting the use of binding arbitration. Arbitration pursuant to the terms hereof shall bind all parties whose claims arise out of, or in any way relate to, services provided, not provided, or to be provided by EvolveGene, or any employee, agent, or independent contractor of EvolveGene. You further understand and agree that, if you are agreeing to the terms hereof on behalf of some other person for whom you have responsibility, then, in addition to yourself, such person(s) will also be bound by these terms, along with anyone else who may have a claim arising out of the services rendered, not rendered, or to be rendered to such person(s).

The plaintiff shall initiate arbitration by serving a Demand for Arbitration on each defendant. The claim shall be mailed by Certified, Return Receipt Requested, U.S. Mail, to said defendant, which, in the case of EvolveGene, shall be 12105 28th Street, Suite A, Saint Petersburg, Florida 33716. A Demand for Arbitration must be communicated in writing to all parties, identifying each defendant, describing the claim against each party, the amount of any damages sought, and the names, addresses and telephone numbers of the plaintiff and his or her attorney.

The plaintiff and defendant shall each select an arbitrator (party arbitrator) within 45 days of the Demand, and a third arbitrator (neutral arbitrator) shall be selected by the party arbitrators within a reasonable time thereafter. In the event the claim is less than $15,000, the arbitration will be determined by a single, neutral arbitrator, selected by the parties.

The plaintiff shall pursue his or her claims with reasonable diligence, and the arbitration shall be governed pursuant to the provisions of the Florida Arbitration Code, Florida Statutes §682.01, et. seq. and the Florida Rules of Civil Procedure. The arbitrator(s) shall apply the Florida Rules of Evidence and the Florida Rules of Civil Procedure in the arbitration proceeding. The arbitration award shall be final and binding, without the right of appeal, except as may be provided under Florida law.

The parties shall bear their own attorney fees and costs in relation to all preparation and attendance at the arbitration hearing. The arbitration panel’s fees shall be divided evenly among the parties. Any party who unsuccessfully challenges the enforcement of this agreement shall be required to pay the successful party’s reasonable attorney fees and costs incurred to enforce such agreement (i.e., Motion to Compel Arbitration).

If this arbitration provision is found to be unenforceable, and arbitration is not compelled, then, as a default, the parties agree that any and all disputes described herein shall be resolved solely by a judge via a bench trial. Under no circumstances will a jury decide any dispute hereunder. If any part of this arbitration provision is held invalid or unenforceable, the remaining provisions shall remain in full force and shall not be affected by the invalidity of any other provision.

8. FINANCIAL AUTHORIZATION

By agreeing to this Informed Consent, you acknowledge and agree to the following:

A. That you authorize EvolvGene to provide your designated insurance carrier any and all of the information, including screening results, necessary for processing your insurance claim.

B. You authorize the benefits under this claim to be payable exclusively to EvolveGene.

C. You understand that your insurance carrier may not approve and reimburse your genetic screening or counseling services in full or at all, due to a variety of reasons, and you agree that if your insurance carrier determines that such services are not covered or not medically necessary, you will be responsible for payment if you choose to proceed with such services.

9. PATIENT AGREEMENT AND CONSENT

By agreeing to this Informed Consent, you acknowledge and agree to the following:

D. That you are at least 18 years old or are legally recognized as an “emancipated minor” by the state in which you reside (e.g., under the age of 18 and pregnant).

E. That you have read, understand and agree to the contents of this Informed Consent.

F. That you have been offered the opportunity to ask questions and discuss with your healthcare provider the benefits, risks and limitations of the screen to be performed.

G. That you have discussed with the healthcare provider ordering this screen the reliability of positive or negative screening results and the level of certainty that a positive screening result for a given disease or conditions serves as a predictor of that disease or condition.

H. That you have been informed of the importance and availability of genetic counseling.

I. That you are responsible for informing your ordering physician of relevant personal medical history and family history.

J. That you understand that EvolveGene may contact you in the future for research opportunities, and that EvolveGene may use your de-identified information and screening results for validation, educational and/or research purposes, and this data may be submitted in a HIPAA-compliant manner to research databases.

K. That if you have the legal authorization to provide this Informed Consent on behalf of another person, you are representing that the sample provided belongs to that person.

L. That you will not use our website or any of our services for any purpose that violates local, state, national or international laws, or that is misleading, malicious, discriminatory or prohibited by the terms hereof, and that you will not use any of our services in any manner that could interfere with any other party’s use and enjoyment of our services.

By agreeing to this Informed Consent, you consent to the following:

A. The storage of your data in the EvolveGene database, which is maintained exclusively through and under encrypted Cloud storage processed in the United States according to United States Law.

B. The use of the leftover specimen and health information as described in this consent.

C. Having this screen performed by an of our designated independent laboratory, operating and undertaking such laboratory work in the manner required by and in accordance with the state in which such laboratory is located.

D. The release of your results to your medical provider, and you agree to discuss the results and appropriate medical management of your healthcare with your provide.

E. To undertake this screening service subject to your full understanding of the information and limitations set forth in this consent and the acknowledgements and understandings set forth herein.