ColoClear Informed Consent

This Informed Consent reviews the benefits, risks and limitations of undergoing colorectal cancer screening using ColoClear (“Test”) provided through Prenetics Limited, hereinafter 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 are being provided for this Test. If you are a parent or guardian agreeing to the 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. By activating the Test, you confirm and acknowledge that you have read, understood, and agreed to this Informed Consent. You understand that the Test is voluntary and that you are not required to have the Test. Prior to proceeding with the Test, you may wish to speak with a healthcare provider about the Test. 

Please note that the laboratory which is processing your sample is a laboratory certified to ISO-15189:2012 in Hong Kong operated by Prenetics Limited.

1. Personal Information. You will be asked to provide certain information about yourself (“Personal Information”). In order for the Test to be performed as intended, you must provide accurate and complete Personal Information. If you are submitting Personal Information on behalf of another person, you represent and warrant that you are authorized to provide such Personal Information, and that all such information is accurate and complete.
2. Stool sample. You will be asked to provide a stool sample in accordance with our instructions. You should follow the instructions carefully, especially the collection, packing and return procedures.

Your results will be released to you or your authorised doctor, 5 working days after your sample is received by the laboratory.

Positive results: A positive result indicates that the sample you provided contains DNA biomarkers indicative of colorectal cancer, advanced adenoma or benign neoplasia and that you are likely to have lesions that can be observed with a colonoscopy. If you receive a positive result, you should seek medical attention for any follow up treatment and procedures. 

‍Negative results: A negative result indicates that based on your sample, you have a low probability of colorectal cancer or advanced adenoma (adenomatous polyps with more advanced pre-malignant features). The screening interval of stool-based DNA tests is 1 to 3 years. 

‍False positives or negatives: False positives or negatives do occur from time to time. Whether you receive a positive or negative result, if you are experiencing symptoms involving the colon, changes in bowel movement or alterations in stool characteristics, or if you are in doubt regarding the Test, you should consult your healthcare provider for further examination. 

‍Inconclusive results: On rare occasions, a result may be inconclusive due to issues with sample collection or processing errors. Prenetics will endeavour to identify and correct any such issue and may be required to obtain an additional sample from you. Prenetics will not be liable for any delays or additional costs due to an inconclusive result.

Your sample will be collected by yourself. If, for any reason, the sample is improperly collected or handled, you may not receive a valid result, or the results may be false. 

There is a risk of a false positive or negative result.

The Test may reveal sensitive information about your health in relation to colorectal cancer. There is a potential risk of loss or misuse of this information. To mitigate this risk, we implement and frequently review certain physical, managerial, and technical safeguards that are designed to protect the confidentiality, integrity and availability of your Information and to prevent information security incidents.  We adhere to international information security standards, including ISO 27001 Information Security Standards. In the event of a security incident or data breach, we will follow internal procedures to investigate the matter as well as comply with all applicable regulatory requirements.

The Test will provide you with an indication, not a conclusive finding, of whether you may have colorectal cancer, advanced adenoma or benign neoplasia based on the sample you provide. According to standard laboratory testing protocols, if a sample returns a positive result, a second test will be carried out with the same sample to confirm its status. You are advised to seek medical attention to confirm your results if you are in doubt.

The Test may return false negative or false positive results. A negative result does not mean that you do not have colorectal cancer, advanced adenomas or benign neoplasia. It may be in the early development stage of the cancer, the targeted biomarkers may not be detectable. A negative result could also be due to your sample not being collected properly.

Prenetics complies with the applicable requirements of the Personal Data (Privacy) Ordinance in Hong Kong SAR in its use of your personal information, and sets out details of how it collects, uses, stores, processes, and transfers your information when using its Services in its Privacy Statement, which is available on the following website (https://hicircle.com/en-hk/privacy). 

While we cannot guarantee that unauthorised access, disclosure, misuse or loss of Information will never occur, we implement and frequently review certain physical, managerial, and technical safeguards that are designed to protect the confidentiality, integrity and availability of your Information and to prevent information security incidents. In the event of a security incident or data breach, we will follow internal procedures to investigate the matter as well as comply with all applicable regulatory requirements.

Any information shared through surveys, or other features on our website, is voluntary and done at your sole risk. Unless due to gross negligence or misconduct on our part, we cannot take responsibility for any breach of your responsibilities, which includes but not limited to allowing others to access your account and password, or onwardly sharing or releasing publicly your Information and you will indemnify us and our affiliates against any liability or costs arising from claims by other people based on the access and use of your account.

Subject to statutory disclosure requirements, the only parties who would have access to your test results would be yourself, your physician and Prenetics. Prenetics does not share the data with any other third party without your consent.

Your information and results may also be shared with any healthcare provider that you designate. You also agree that we may use your information and share any information needed to third party logistics providers in order to deliver the Test to you.  

We store your information as required by applicable laws and regulations.

We will retain the 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.

Your sample and results may also be de-identified, stored and used for internal quality control; validation studies; and in publications authored by us, either on our own or in collaboration with academic third parties.

a) I have read the informed consent and fully understand its content. I willingly consent to taking the Test. I understand that the reported results and information do not constitute medical advice by Prenetics. I acknowledge that Prenetics has advised me to avoid making 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.

b) I agree to the analysis, use, processing and storage of my sample and information, including personal information and health information, by Prenetics. 

c) I agree to the use of my sample for regulatory and compliance purposes, internal quality control, laboratory validation studies, and research and development purposes, provided that my sample is de-identified. De-identified study data means that all personal information about me (such as name, address, birthdate and phone number) will be removed and replaced with a code number. This deidentified study data may be used for clinical studies or other studies for the detection of colorectal cancer as determined by Prenetics. All samples will be destroyed after the end of the applicable retention period.

a) I confirm that the sample provided is mine and I am at least 18 years of age, or if I am submitting a sample for someone else, I have the legal authority to consent for the 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.

b) I confirm that all information provided by me is true and complete.

c) I confirm that I have the authority to provide this consent.

Please collect your sample according to the calendar below. Dates in gray boxes are not recommended for sample collection. Note: sample collection refers to sampling stool specimens from your body, not sample pick-up by courier.