Patient Information Sheet for the TruCheck® Intelli Multi-Cancer Early Detection Test

This document provides information about the TruCheck® Intelli multi-cancer early detection blood test. It should supplement any discussions with a healthcare provider regarding the purposes, benefits, risks, and limitations of the test. The test can only be ordered by licensed healthcare providers, and deciding to undergo this test is your choice. We encourage you to ask any questions you may have about this test.

Purpose of the Test: TruCheck Intelli is recommended for use in asymptomatic adults with only age-associated risk for cancer. The TruCheck test is intended to be used as a tool for cancer screening. The use of TruCheck is not recommended in individuals who have previously had cancer, or who have symptoms of cancer. For those with symptoms of cancer, we recommend seeking expert medical advice without delay.

The purpose of the TruCheck test is to detect Circulating Tumor Cells (CTCs) and their clusters that may be present in the blood at the time a blood sample is provided. CTCs and clusters are present in the blood of almost all solid organ cancer patients and are undetectable in healthy individuals. If a malignancy signal is detected, the test is also designed to suggest the likely organ of origin and type of malignancy. The test detects cancer signals from CTCs in the blood but does not diagnose cancer. Information from this test is intended to help healthcare providers determine appropriate follow-up tests to confirm whether cancer is present.

Testing Process: The company that created and performs the TruCheck test will test your blood sample to look for CTCs that may have come from cancer cells. This may indicate the presence of cancer and if it is present, the location and the type of the cancer. TruCheck will report the results of the test to your healthcare provider, who will share the test results with you. Depending on the test results and other clinical and risk factors, you and your healthcare provider may decide what additional follow-up tests, using clinically established procedures, are needed to confirm if cancer is present based on the results of the TruCheck test.

Limitations of the Test: The TruCheck test does not detect all cancers and should be used as a tool for cancer screening. TruCheck is intended to detect cancer signals and suggest where in the body the cancer signal is coming from and its type. Results should be interpreted by a healthcare provider in the context of medical history, cancer risk factors, and clinical signs and symptoms. A test result of “negative for malignancy” does not rule out cancer. A test result of "positive for malignancy" requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer. False-positive (a malignancy signal detected when cancer is not present) and false-negative (a malignancy signal not detected when cancer is present) test results do occur. Laboratory/Test Information. TruCheck’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The TruCheck test has not been cleared or approved by the Food and Drug Administration. TruCheck’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The TruCheck test is intended for clinical purposes.

Disclosure of Test Results: Your TruCheck test results are confidential; these results, as well as your leftover blood sample and medical information, may be disclosed to the following limited group of individuals and organizations:

• Your healthcare providers (or their designated representative); and/or
• Your health insurance company (if TruCheck seeks to receive payment from your insurer instead of from you directly or if your health insurance company needs information about your test result in order to provide coverage for any follow-up care).

Secondary Data Uses: The individuals or entities listed above may generate, keep, use, and/or share your test result information that has been removed of information that readily identifies you in accordance with applicable federal law. In addition to your TruCheck test results, your leftover blood sample and medical information (including certain follow-up clinical information) that have been removed of information that readily identifies you may be shared within TruCheck and with third parties. These secondary uses may:

• Improve or evaluate the performance, safety, effectiveness, or quality of TruCheck’s products;
• Help develop guidelines for health care providers to follow when other patients receive a “Positive for Malignancy” result from the test;
• Inform you or your healthcare provider about treatments, products, and services from TruCheck or other companies that are relevant to your test result;
• Inform you or your healthcare provider about clinical trials for which you may be eligible; and/or
• Be used for test validation, research, and/or other future purposes, unless prohibited by applicable law.

Retention of Sample: TruCheck may choose to destroy the sample at the end of the testing process or retain the processed blood sample indefinitely and use the blood sample without information that readily identifies you for certain activities, including research purposes, to the extent allowed by applicable law. Once a diagnosis is confirmed patients will be referred to their local hospital for standard of care treatment via the NHS. Patients with an indeterminate result will need to repeat the test. Repeat testing is provided free of charge.

Data Privacy: The patient's personal data and results are stored and managed in accordance with the European Union's General Data Protection Regulation (GDPR). The data is stored within a secure, encrypted cloud-based system and the use of the patient's data outside of the scope of the patient's consent will be a violation of the patient's rights under GDPR.

Customer Service: For any questions regarding the test or results, patients may contact us at +44 (0) 20 8133 8193 or info@cancerscanuk.co.uk. If you have medical concerns, we advise you to contact your doctor.

Patient Acknowledgement: We advise patients to consult with their healthcare provider before proceeding with this test. Patients should understand the benefits, risks, and limitations of the test, and are encouraged to ask any questions they may have before proceeding.

I agree to receive the services provided by CancerScan UK Ltd and our partners, including but not limited to laboratory testing oversight, clinical review of test requests, receipt of test results, counselling services, customer support, and any other related services (collectively referred to as the "CancerScan UK Services").

By consenting, I agree to the following:

1. I confirm that I am at least 18 years old and that I am providing the sample for the test.
2. I understand that providing accurate information is vital. I will not hold CancerScan UK Ltd or its healthcare providers responsible for any errors or omissions that I may have made in providing such information.
3. I confirm that I am a UK resident.
4. I understand I have the right to speak with a healthcare provider about the test and/or my results. Counselling is available to help me understand what the results mean for me.
5. I understand that the information I have submitted will be reviewed by healthcare providers affiliated with CancerScan UK Ltd.
6. I understand that before my request for the test is approved, the CancerScan UK Ltd clinical team will evaluate my personal and family history information to determine if the test is appropriate.
7. I am responsible for sharing any results with my GP and for initiating follow-up with such doctors for care, diagnosis, or medical treatment.
8. I will not make medical decisions without consulting a healthcare provider, nor will I disregard medical advice or delay seeking such advice based on the CancerScan Services.
9. I understand that testing is voluntary, and I may withdraw my consent to the CancerScan UK Services by contacting our customer service team at help@cancerscanuk.co.uk.
10. I have received satisfactory answers to all my questions and understand the purpose of the test.
11. I have been provided with enough information regarding the test and have had the opportunity to discuss it with a provider. I understand the reliability of a positive or negative result and the level of certainty of a positive result as a predictor of the disease or condition being tested for.
12. I understand that I can contact CancerScan UK Ltd’s customer service team with any questions before or after my test.
13. I understand that if I have any changes to my personal information that I provided in connection with the CancerScan UK Services, it is my responsibility to contact CancerScan UK Ltd’s customer service team.
14. I understand that the CancerScan UK Services are provided electronically. I also understand that there are potential risks associated with the use of technology, including disruptions, loss of data, and technical difficulties.
15. I understand that alternative services exist, such as visiting a primary care provider, but I choose to proceed with the CancerScan Services at this time.

Data Authorisation

I specifically authorise the transfer and release of my information, including my lab test results and other health information, to and among the following individuals, organisations, and their representatives:

1. The applicable laboratory and its staff, agents, and healthcare providers, including physicians and counsellors.
2. CancerScan UK Ltd and its affiliates, and their staff, agents, and healthcare providers.
3. Any service providers as required or permitted by law.

I understand that I can refuse to agree to this authorisation, in which case it may affect the services provided to me. I also understand that my information may be subject to redisclosure by the recipient and may no longer be protected by privacy laws.

I have the right to revoke this authorisation in writing at any time, except that the revocation will not apply to any information already disclosed by the parties referenced in this authorisation. This authorisation will expire ten (10) years from the date of consent. My written revocation must be submitted to CancerScan UK Ltd’s Legal Department at: CancerScan UK Ltd Attn: Legal Department, 5 Beaufoy Walk, London, SE11 6AA

Please review the CancerScan UK Ltd Privacy Policy and Terms of Use.

By clicking "Continue," you acknowledge that you have read, accepted, and agreed to be bound by this informed consent. If you do not click "Continue," you will not be able to use or receive the services.

In addition, by clicking "Continue" and requesting the test, you agree to the consent for services.