Circle Informed Consent
This Informed Consent is provided by Prenetics Limited, which together with its affiliated companies, is collectively referred to herein as
“Prenetics","we","us" or "our".Prenetics is the provider of the genomics test that you are purchasing (the "Service")
This Informed Consent:
1) reviews the benefits, risks and limitations of the Service which you have selected;
2) explains how your personal information, personal health information, genetic data, and biological sample will be used in connectionwith the Service; and
3) seeks your acknowledgement and consent to this document, the risks and limitations of the services, and to our processing of yourbiological sample and information in connection with your Service.
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 (as permitted by the TOS depending on your country of residence), “you” may also refer to your child, as contextually appropriate.
In order to proceed with the Service, you must confirm that you have read, understood, and agree to this Informed Consent.
Your use of the Service is voluntary . It is your choice whether to use our Service or not. Prior to proceeding with the Service, you (and your guardian or parent, as appropriate) may wish to speak with a healthcare provider.
What we collect and how it is used
● Personal Information. If you request a Service or create an account, you will be asked to provide certain information, including
personal information. We will only collect information that is necessary for our provision of the Service to you.
● Personal Health Information (“PHI”). You may voluntarily provide additional personal health information via surveys or during
calls if you request for a teleconsultation with our health consultants or genetic counsellors.
● Biological sample. You will also be asked to provide a sample in accordance with our collection procedures. Your sample and Personal Information will be transferred to our laboratory. DNA will be extracted from the submitted sample and analysed.
● Genetic Data. Genetic data includes information about genes and genomic regions relevant to the ordered CircleDNA Test.
● Report or test results. Upon successful completion of CircleDNA Test, your personal information, genetic data, and PHI will be used to create a report which would be made available to you (hereinafter referred to as “Report" or "test results”). You should not make important medical decisions on disease treatment or prevention in reliance on the test report without consulting your healthcare provider.
● Regulatory compliance, Internal quality control, Validation studies. Your sample and Genetic Data may also be processed for regulatory compliance, internal quality control and validation studies.
● Further opt-ins. You may consent to future products or services, or opt in for third party research and our research database, as described below. We will not use your information or report on matters beyond those relevant to your ordered Service without your consent.
(1) For the Service to perform as intended, you must provide accurate and correct information. Failure to do so may result in yourbiological sample not being tested.
(2) If another person is submitting information on your behalf, by agreeing to 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.
(3) In the event we determine that a biological sample is not suitable for processing and analysis due to incorrect collection,contamination of sample or violation of this consent or the TOS, we reserve the right to terminate the Service to you without providing anyrefund.
(4) You are responsible for ensuring that by providing your biological sample, you are not violating any export ban or other legalrestriction in your country.
Further details on the use of your information are set out under “Use of Your Information” below.
Benefits of the Services
Your disease and cancer categories 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 hereditarydisorders at an earlier and potentially more treatable stage. Because relatives share some genetic features, your results may also beinformative to your biological relatives.
Your Family Planning test results may show you are a carrier of genetic conditions that could affect your family by analysing the risk profileof 163 potential conditions based on your genes. You may be carriers of genetic conditions without knowing about it. If both of you andyour partner are carriers for a certain condition, in general, there is a 25% chance that your offspring could develop a condition.
Your diet and fitness categories test results may give you further understanding of your own macro- and micronutrient needs, yourresponse to power or endurance exercise and recovery speed and sports injury risk. Such insight may allow you to use your GeneticInformation to explore personalised solutions to reach your fitness and nutritional goals. Genetics is only one part of the picture, and sothe value comes from understanding your genetic profile so that you can make sustainable changes that support your own goals, lifestyleand environment.
Your drug response categories test results may give you insights to help you select the medication(s) and dose(s) that are best suited toyour condition and genetic makeup. The results will identify the right medication, the proper dosage as well as medications that may beharmful for you across more than 100 FDA-approved medications. With this information, you can help inform your physician and/orpharmacist about the optimal medication and dosage based on your genes and prevent potential adverse reactions to drugs.
Risks of the Services
The Services includes a genetic test that may reveal sensitive information about your health, personal traits, or potential risk fordeveloping certain tested diseases or conditions.
Depending on your country of residence, there may be significant differences in the laws and regulations governing the use and disclosureof genetic information, or there may not yet be any laws or regulations governing the use or disclosure of genetic information. While weare not aware of this being a current issue, in the future, the results of genetic testing may impact your ability to obtain life, disability orlong-term care insurance.
Limitations of the Services
Depending on the Service/ CircleDNA Test you have selected, such Service or CircleDNA Test is intended to detect mutations within aspecified reportable range of selected genes and/or genomic regions, which known to be associated with an increased risk for certaintypes of inherited disorders, personal traits, and/or associated with nutrient needs and exercise responses. However, CircleDNA Test maynot detect every mutation associated with disease risk, and/or detect every mutation associated with exercise responses, nutrient needsor sensitivities.
Analysis of results is based on currently available information in the medical literature and scientific databases, as well as laboratoryinformatics and algorithms that may be subject to change.
New information may replace or add to the information that was used to analyse your results. Based on this new information and/ormodifications to our laboratory informatics and algorithms, you understand and agree that we may, at its sole discretion, amend ormodify your CircleDNA Test report. This may result in a change in your risk assessment; a reclassification of a mutation or a reporteddiplotype; or a change or update to a previously reported allele.
You hereby irrevocably waive any and all claims against us for any amendment or modification of CircleDNA Test Report andcorresponding services in accordance with our standard operating procedures.
This Report reflects the analysis of an extracted DNA sample. In very rare cases (circulating hematolymphoid neoplasm, allogeneic bonemarrow transplant, recent blood transfusion), the results of CircleDNA Test will be interfered by the neoplastic or the donor DNAs and thatthe analysed DNA may not represent the patient’s constitutional genome. In addition, under rare genetic conditions, including mosaicismand genetic chimerism etc, the analysed DNA may not totally represent the patient’s constitutional genome.
CircleDNA Test utilizes whole exome sequencing (WES) technology. The test analyses the following types of mutations: single nucleotidevariations (SNVs) and small insertion/deletions (In/Dels; up to 50bp) in exonic region, nearby 5bp flanking regions, and a limited selectionof intronic regions.
● It is not intended to analyse the following types of variations: poly-structures, tandem repeats, GC-rich regions, and homologousregions (pseudogenes).
● This test may detect a varying percentages of known and unknown variations. This assay achieves 99% sensitivity and specificity for single nucleotide mutations and small In/Dels (<50bp). Sensitivity to detect insertions and deletions larger than 50bp but smaller than a full exon may be marginally reduced.
● This test will not detect mutations in promoter regions and other non-coding regions. Due to the limitations of technology, this testdoes not guarantee 100% coverage of target captured regions of exome, CNV variations, and all genetic mutations in the tested genes.Also, interpretation of mutations in exonic regions would be limited by the timeliness of literature and databases, the complexity ofdiseases and the limitations of medical and science development.
● The test results could not rule out the possibility of other disease development due to the genetic mutations detected.
The breakpoints of large HBA1/HBA2 deletions/duplications are not determined and similar size deletional mutations are notdistinguished. In addition, the phase of identified genotypes will not be provided. Individuals carrying both duplication and deletion withinthe alpha-globin gene cluster may appear to have alpha-globin gene copies with a normal number. This may rarely occur and othersimilar compensatory changes could exist in both HBA1 and HBA2 genes. This may not be detected by the current test. Acquired or raresyndromic forms of alpha thalassemia associated with ATR-X and ATR-16 syndrome will not be detected. Rare sequence variations canlead to detection errors during the testing process.
CircleDNA Test is not designed to detect chromosomal aneuploidy or complex gene rearrangements, including translocation, largeinsertions, and inversions. It also does not reliably detect mosaicism.
Information regarding genetic variations with no or unknown significant association with conditions may become evident (calledIncidental Findings). Circle’s policy is to not report or comment on any Incidental Findings that may be noted in the course of analysing thetest data.insertions, and inversions. It also does not reliably detect mosaicism.
CircleDNA Test does not constitute a definitive test for the selected condition(s) in an individual. Besides genetic factors, environmentaland other factors including:
● dietary factors,
● accumulation of somatic mutations in the genome,
● infection of the oncovirus,
● and / or a smoking history, etc.,
may also contribute to the development of different diseases or health conditions. CircleDNA Test is not a diagnostic test and should beused in context with other clinical findings by the healthcare provider to help with a diagnosis and treatment plan.
CircleDNA Test only reports the presence of inherited genetic variations of the selected genes, which were known to have association withdevelopment of certain diseases, health conditions or other traits.
Other known mutations and genes not listed are not reported and CircleDNA Test may not detect all known mutations that results inabnormal biological activity.
It is possible that untested site of variation may confer altered biological activity in an individual, leading to the rare possibility of a non-functional, decreased or increased functional allele being erroneously called as “wild-type”. CircleDNA Test only detects the DNAsequence in the protein-coding regions of the selected genes, DNA sequence other than the protein-coding regions or the selectedintronic regions are not investigated by this test.
CircleDNA Test results do not eliminate the possibility that the genetic variations may have risk of developing other diseases, includingother cancers and carrier diseases.
Risk estimation for particular categories will only be provided with satisfactory data quality. All risk estimation is approximate, sometimescannot be specifically calculated, and is based on previously analysed cohorts. Risk estimation of particular categories are:
● gender specific and they might only be applicable/available for certain gender.
● also population-specific, the estimated risks could be over- or under-estimated if you are not East Asian, Caucasian or South Asian.
An elevated risk of particular categories is not a diagnosis and does not guarantee that a person will develop the characteristics ofinterests (i.e. disease or traits etc). Risk calculation is only based on the ethnicity and gender provided by you. Incorrect/inaccurateinformation will greatly affect the accuracy of the risk calculation.
Informational Purposes Only
This Service does not provide diagnosis, or treatment. The Report and comments are for informational purposes only and should not beinterpreted as specific professional medical advice. This Report is based on tested genes and mutations. Untested genes, mutations, non-genetic factors and accumulation of somatic mutations also influence your disease, health status and other characteristics.Environmental and lifestyle factors also often play a large role in the risk of developing diseases or health problems.
Please speak with your healthcare provider for further advice and before making any changes to your diet or lifestyle or before makingdecisions about medical conditions, or before starting and stopping any treatment prescribed for you.
This Report is based solely on the sample and information provided to Prenetics and does not take all factors related to your health intoaccount. Therefore, Prenetics’ employees shall have no liability to any person or entity with regards to claims, loss, or damage caused, oralleged to be caused, directly or indirectly, by the use of information contained in the Report.
Privacy and data security
Your privacy is important to us.
● We comply with Hong Kong laws. 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. You understand and consent to our collection, use, processing andstorage of your information, and our handling of your biological sample in accordance with Hong Kong laws and regulations, which maydiffer from those of your country of residence.
● We implement physical, managerial, technical safeguards to protect your information. While we cannot guarantee that unauthorised access, disclosure, misuse or loss of information will never occur, we implement and frequently review physical, managerial,and technical safeguards to protect the confidentiality, integrity and availability of your information and to prevent information securityincidents. In the event of a security incident or data breach, we will follow internal procedures to investigate the matter as well as complywith all applicable regulatory requirements.
● Your responsibility. You are responsible for maintaining the confidentiality of your login credentials for your account and for all the
activities that happen under your account. Sharing information through surveys or other features on our website is voluntary and done atyour sole risk. We are not responsible for any breach of your responsibilities, which includes but is not limited to allowing others to accessyour account and password, or onwardly sharing or releasing your information publicly and you will indemnify us and our affiliates againstany liability or costs arising from claims by other people based on the access and use of your account.
Further details about our policies governing customer privacy and information, including customer rights regarding such information, canbe found at www.circledna.com/privacy, or will be made available to you upon request by emailing [email protected].
Use of your information
● To deliver test results to you . As part of the Service, you are requesting that your test results be made available to you, as may be
specified in your account or order form.
● To deliver test results and data to your healthcare provider . If you request that your test results be shared with your
healthcare provider or any other third party, you consent to our provision of your test results, including any related Personal Information,PHI, or Genetic Data, to your designated healthcare provider or third party. If your ordering provider is part of a clinic or health system,Prenetics may, with your consent, provide such clinic or health system with your results and information, other sequencing data, PersonalHealth Information, and related analyses, for your clinic’s or health system’s use for treatment, payment, healthcare operations, dataanalytics, research or other purposes, for which your clinic or health system has agreed to comply with applicable laws.
● To communicate with you . We may use your Personal Information to communicate with you about your collection kit, order, test results, account details, and other logistics and procedures in relation to the Service.
Retention of your information
● Storing of your data. 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 resultsprovided.
● Retention of your sample. We will retain your 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 anonymise your sampleand use or store it for regulatory compliance purposes; internal quality control; laboratory validation studies; or, with your consent,research and development.