Circle Informed Consent

Introduction.


This Informed Consent reviews the benefits, risks and limitations of undergoing genetic testing as selected on your order form or in your account settings (“Test(s)”, as described in further detail below) provided through Circle (“Circle”), DNAFit Life Sciences Limited (“DNAFit”), and their parent company, Prenetics Limited, collectively referred to as “Prenetics”, “we”, “us”, or “our”. It also explains how your information and sample will be used in connection with the Test. Throughout this Informed Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and sample is being provided for this Test. If you are a parent or guardian requesting a Test for a minor, “you” may also refer to “your child”, as contextually appropriate. In order for us to process your sample and provide you and your healthcare provider with your report you must confirm by signing below or otherwise acknowledging that you have read, understood, and agree to this Informed Consent. You understand that the Test is voluntary and that you are not required to have the Test. Prior to signing this Informed Consent, you (and your guardian or parent, as appropriate) may wish to speak with a healthcare provider about the Test.


The Cancer DNA Test provided by Circle aims to detect clinically relevant variants within 35 genes analyzed, subject to the Limitations of the Test section below. All genes in this test have been implicated in cancer predisposition and are associated with an increased lifetime cancer risk, although these risks may differ, depending on the particular gene.


The Diet Fitness Pro 360 Test provided by DNAFit aims to detect clinically relevant variants within the panel of genes analysed, subject to the Limitations of the Test section below. Genes analysed in this test may reveal insights for your training intensity response, aerobic trainability and recovery capacity, to a detailed breakdown of your macro- and micronutrient needs, diet type recommendations, and caffeine, salt, gluten and alcohol sensitivities and detoxification ability. These insights will allow you to make genetically informed choices for your lifestyle.


The Tests and laboratory.


We, via Prenetics, operate a clinical testing laboratory accredited under the international standard. The Tests were also externally validated by recognized Universities and supported by a rigorous volume of research conducted by leading science and research institutes around the world.


What we collect and how it is used.


If you request a Test, you will be asked to provide your Personal Health Information (PHI). In order for the Test to perform as intended, you must provide accurate and correct information. If another person is submitting your PHI or related information on your behalf, by signing this Informed Consent, you represent and warrant that such person is authorized to provide such information, and that all such information is accurate and correct. If you are providing personal information about your relatives, you also represent and warrant that you have obtained permission from such relatives to disclose such information to us.


You will also be asked to provide a DNA sample in accordance with our collection procedures. Your sample and PHI will be transferred to our laboratory in Hong Kong SAR for processing. DNA will be extracted from the submitted sample and analyzed. Genetic data includes information about genes and regions relevant to the ordered Test. All genetic data may be used for regulatory compliance, and de-identified for internal quality control, validation studies, and research and development purposes. Reporting on genes and regions beyond those relevant to the ordered Test will not occur unless you consent to future products or services, or unless you opt into third party research and our research database as described below.


Upon successful completion of the Test, you hereby request that a report be made available to you for review. You should consult with your healthcare provider about your results.


Benefits of the test.


  • Your Cancer DNA Test results may show you have an increased risk of developing certain types of hereditary disorders. Knowing this may help you and your healthcare provider make more informed healthcare decisions to prevent or detect hereditary disorders at an earlier and potentially more treatable stage. Because relatives share some genetic features, your results may also be informative to your biological relatives.
  • Your Diet Fitness Pro 360 Test results may give you further understanding of your own macro- and micronutrient needs, your response to power or endurance exercise and recovery speed and sports injury risk. Such insight may allow you to use your Genetic Information to explore personalised solutions to reach your fitness and nutritional goals. Genetics is only one part of the picture, and so the value comes from understanding your genetic profile so that you can make sustainable changes that support your own goals, lifestyle and environment.


Risks of the test.


The Test is a genetic test that may cause you to discover sensitive information about your health or disease risks. If you live outside of Hong Kong, depending on your country of residence, there may be significant differences in the laws and regulations governing the use and disclosure of genetic information, or there may not yet be any laws or regulations governing the use or disclosure of genetic information.


Limitations of the test.


Depending on the Test you have selected, such Test is intended to detect variants within a specified reportable range of selected genes known to be associated with an increased risk for certain types of inherited disorders, and/or associated with nutrient needs and exercise responses. However, this test may not detect every variant associated with disease risk, and/or detect every variant associated with exercise responses, nutrient needs or sensitivities.


Analysis of results is based on currently available information in the medical literature and scientific databases, as well as laboratory informatics and algorithms that may be subject to change. New information may replace or add to the information that was used to analyze your results. Based on this new information and/or modifications to our laboratory informatics and algorithms, you understand and agree that we may, at its sole discretion, amend or modify your Test report. This may result in a change in your risk assessment; the reclassification of a variant; a change or update to a previously reported allele; or a reclassification of a reported diplotype. You hereby irrevocably waive any and all claims against us for any amendment or modification of the Test report in accordance with our standard operating procedures.


As part of the Cancer DNA Test, we may also identify the presence of Variants of Uncertain Significance (VUS), which are genetic variants that require further research to determine if they are associated with an increased risk for a hereditary disorder. We will provide further detail about such VUSs if: (a) you or your healthcare provider elects to receive such information; (b) additional research enables us to reclassify a variant; or (c) we determine at our reasonable discretion that you should be made aware of this information. You should discuss the results of the Test and the presence of VUSs (if any), as well as any changes to your Test report, with your healthcare provider or a genetic counselor. In order for us to provide you with updates regarding your test results (including the reclassification of VUSs), your Circle account must remain active with your up-to-date contact information.


We implement several safeguards to avoid technical errors, but as with all medical tests, there is a chance of a false positive or a false negative result. A false positive result means that genetic variation was reported which is not in fact present. A false negative result means the Test failed to identify a genetic variation that is in fact present and within the reportable range.


Other sources of error, while rare, include sample mix-up, sub-standard sample quality or contamination, inherent DNA sequence properties, and technical difficulty in the laboratory. In addition, if you have certain rare biological conditions or have had certain bone marrow, kidney, liver or heart transplants, transfusions, or hematologic malignancies, these conditions may limit the accuracy or relevance of the results or prevent the Test from being completed. We expressly disclaim any liability for the inaccuracy of Test results resulting from such conditions or the failure to provide accurate, correct or complete PHI (including your medication history), and you expressly waive any claims against us with respect thereto.


Potential Results for Cancer DNA Test.


For genes related to disease risk, a positive result means that we’ve identified a genetic variant that may increase your risk for a certain type of disorder, and a negative result means that no variants that are known to increase risk were found. The Test is not a diagnostic test. Positive results do not necessarily mean that you have that hereditary disorder or that you will develop the disorder in your lifetime. Negative results do not eliminate your risk of developing a disorder, and do not guarantee that you will be healthy or will never develop any of the disorders that we test for.


Test results may have implications for family members. If you are found to carry a variant in any of the genes analyzed, this may also have implications for your family members as certain genes are hereditary. This should be discussed with your healthcare provider. In addition to increasing cancer risk, some genes on this panel have also been implicated in other genetic conditions which are inherited in a recessive manner. This means that if you are identified to carry a variant in one of these genes and your child’s other biological parent also carries a variant in the same gene there is a 25% chance of a child being affected by one of these recessive conditions. The overall risk of having a child affected with one of these conditions is low. Further testing of you or your reproductive partner may be recommended based on the results of this test.


You should consult with your healthcare provider or a genetic counselor to ensure you understand your Test results and how they may inform your personalized healthcare plan going forward. By signing this Informed Consent, you understand and agree that your results must be considered in the context of broader medical management by a healthcare provider, and that you should not make medical decisions without consulting a healthcare provider. We do not provide medical services, diagnosis, treatment, or advice.


Privacy and data security.


Your privacy is important to us. Details about our policies governing customer privacy and health information, including customer rights regarding such information, can be found at www.circledna.com/privacy, or will be made available to you upon request by emailing care@circledna.com. We comply with the applicable requirements of the Personal Data (Privacy) Ordinance in Hong Kong SAR and other applicable regulations specific to Hong Kong SAR. We implement certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your protected information. We cannot, however, guarantee the security of any information you transmit to us or store on our websites, and you do so at your own risk. You agree that we are not liable for the unauthorized release of your information, unless such release was the result of gross negligence or willful misconduct on our part. In the event of a data breach, we intend to comply with all applicable reporting requirements. If you are domiciled outside of the Hong Kong SAR, you should consult with your physician and/or appropriate adviser because genetic testing may be subject to specific regulatory constraints, or be prohibited, in certain countries. By agreeing to this Informed Consent you agree that the laws and regulations of the Hong Kong SAR regarding collection, use, processing, and storage of patient information shall govern our performance of the Test and handling of your sample and information, even if they may differ from those of your country of residence. You further agree that by providing your sample, you are not violating any export ban or other legal restriction in your country.


Use of your information and leftover specimens.


  • Upon completion of the Test, you are requesting that your results be made available to you as specified in your account or order form. By agreeing to this Informed Consent, you also agree that your genetic information, PHI, and results can be shared with any healthcare provider that you designate. You also agree that we may communicate with you about your collection kit, order, results, account details, and other Test logistics and procedures.
  • We store your genetic sequencing and related data as required by applicable laws and regulations, and we may use this data to conduct subsequent testing or analysis in the event that (a) you consent to any new product or service offering; or (b) our review of medical literature and/or changes in technology indicate that such analysis is useful or necessary to confirm results provided.
  • We will retain the DNA sample only for the maximum duration permitted under applicable law or regulation (“Retention Period”), after which point it will be destroyed. Until such time that your sample is destroyed, we may de-identify your sample and use or store it for regulatory compliance purposes; internal quality control; laboratory validation studies; or research and development.
  • Data and Sample Use for Public Variant Databases, Regulatory Compliance, Internal Quality Control, Laboratory Validation Studies, Research and Development, and Publications:

    > By signing this consent, you acknowledge and agree that we may de-identify the sequenced and genotyped genetic information and aggregate this genetic information with de-identified genetic information from other clients. De-identification means that personal identifiers associated with your genetic information will be removed. The de-identified genetic variants may be submitted by us to public variant databases like ClinVar to advance scientific and/or medical research.

    > You also agree that your genetic information, PHI, personal data, and results may be stored and used by us for regulatory compliance purposes.

    > With your consent, your genetic information, PHI, personal data, and results may also be de-identified, stored and used for internal quality control; validation studies; research and development; and in publications authored by us, either on our own or in collaboration with academic or commercial third parties (which publications may include, for example, blinded pedigree diagrams or de-identified family history).


Optional use of your information.


Participation in Circle Research and Inclusion in Circle’s Research Database (Optional):


  • You have the option of consenting to the use of your de-identified sample (if you have chosen to store it), genetic information, PHI, personal data, and results in our research with third party collaborators, and inclusion of such information in our research database.
  • Such third parties may include government, academic, or commercial third parties. We may engage in research with such third parties to develop new tests and inventions, or to validate and improve existing technologies or processes. You acknowledge and understand that we may receive financial compensation to conduct such research, which may include providing your de-identified data to such third parties.
  • Our research database supports research in genetics. If you consent, we may de-identify your demographic, health history, and genetic information in order to aggregate it with other participants’ data and make it accessible, searchable, and downloadable from the database by researchers and the general public, for an indefinite period of time. Genetic information in the database may include variants beyond those relevant to the product or service you consented to, but they will be de-identified. Participation in this database involves the possible risk that your information might become known to individuals outside of us, or that you may be identifiable from information in the database. We will attempt to protect your identity and preserve the confidentiality of your information, and will use commercially reasonable efforts to restrict any searches that identify you as a unique or rare carrier of any variants.
  • You can opt out of such third party research and our research database by contacting us at care@circleDNA.com. However, if you have consented in the past and later change your settings to opt out, we cannot retract your de-identified sample (if you have chosen to store it), genetic information, PHI, personal data, and/or results from research already performed, or from previous releases of our research database that have already been published.
  • If any new tests, technologies, processes, or inventions are made as a result of the research activities described above (whether made by us or by a third party), you agree that you will not receive any compensation, nor will you have any right, title, and/or interest in or to such new or improved tests, technologies, processes, or inventions.


Consent.


I confirm that I have read or have had read to me, all of the information in this Informed Consent document, and I understand what it says. I have had the opportunity to ask any questions I may have about the Tests and related issues, and all of my questions have been answered to my satisfaction. I freely and voluntarily consent to undergo this Test, and I specifically acknowledge and consent to the following:


  • The sample being provided is mine and I am at least 18 years of age, or if consenting for someone else, I have the legal authority to consent for such person whose sample is being provided. If the sample being provided is from someone under the age of 18, I represent that I am the parent or legal guardian of the person being tested.
  • The Cancer DNA Test is not intended to diagnose whether I have or will get a certain disorder in the future. It is intended to tell me about my hereditary risk related to certain types of disorders as indicated above.
  • The reported results and information do not constitute medical advice by Prenetics. I should not make any medical decisions or medication changes based on these results without speaking to my healthcare provider first. My healthcare provider remains ultimately responsible for all diagnosis and treatment decisions.
  • My doctor and I can speak with Prenetics’ genetic counselors and/or health coaches at no additional charge.
  • My sample will be analyzed for the genes and regions identified in the Test(s) selected. Prenetics may also analyze additional genes and regions, up to and including the entire genome, and any other DNA present in the submitted sample. My genetic information, PHI, personal data and results may be stored and used by Prenetics for regulatory compliance purposes. My de-identified sample , genetic information, PHI, personal data, and results may also be stored and used for internal quality control; validation studies; research and development; and in Prenetics’ authored publications. Additional analysis and reporting of genes and regions beyond those relevant to the ordered Test will not occur, unless I consent to future products or services, or unless I opt into third party research and Circle’s research database.
  • My sample and all my related personal information will be transferred to Prenetics’ laboratory for analysis, use, processing, and storage, and will be subject to the laws, rules, and regulations of the Hong Kong SAR.
  • All samples will be destroyed after the end of the applicable Retention Period.
  • I agree to the Circle Terms of Service and Privacy Statement, which are available at circledna.com, or upon request.


I certify that all information provided is true and accurate. I agree that I have the authority to provide this consent. I understand that if I wish to withdraw consent, I may do so by contacting Circle.