SG-OCRA™ Informed Consent Form

SG-OCRA™ Oral Cancer Risk Algorithm Test

Test Covered:

• SG-OCRA™ Oral Cancer Risk Algorithm Test

Introduction

This Informed Consent explains the benefits, risks, and limitations of undergoing the SG-OCRA™ test (“Service”) developed by Studium Genetic, distributed by MEDIVEN, and supported by OktoAI for technology and data services. It also explains how your biological sample and personal information will be collected, used, and processed.

“You”, “your”, “I”, or “my” refer to the individual undergoing the test. If the test is ordered or facilitated by a clinician or healthcare professional, consent may be obtained through that clinician in accordance with applicable laws and professional standards.

By continuing, you confirm that you have read, understood, and agree to this Informed Consent. You understand that the test is voluntary and you may choose not to proceed.

Purpose of Testing

SG-OCRA™ is intended to assess oral cancer risk using molecular and/or genetic markers. This test is for screening and risk assessment purposes only and is not a diagnostic test. Results should be interpreted by a qualified clinician and do not replace medical diagnosis or treatment.

Voluntary Participation

Your participation is voluntary. You may withdraw consent at any time before sample analysis by notifying MEDIVEN or the ordering clinician. Withdrawal will not affect results already processed.

Sample Collection & Analysis

Your biological sample will be collected by a clinician or trained personnel and analysed in laboratories designated by Studium Genetics or its authorised partners, in accordance with applicable quality and safety standards.

Data Handling & Privacy

All personal, clinical, and test-related information collected in connection with the SG-OCRA™ test will be handled in accordance with the Personal Data Protection Act (PDPA) and applicable data protection regulations. Studium Genetic is responsible for the development of the test and the scientific interpretation of results, MEDIVEN acts as the authorised distributor and service coordinator, and OktoAI provides secure technology and data processing services in support of system operations, analytics, and result management. OktoAI operates strictly as a service provider and does not own, independently access, or use personal or test data beyond what is necessary to deliver these services. Test results and related information will be disclosed only to the individual tested and/or the ordering clinician, unless explicit consent is provided for sharing with insurers, healthcare providers, or other authorised third parties. All data is stored and processed using appropriate administrative, technical, and organisational safeguards to protect confidentiality, integrity, and availability.

Insurance & Third-Party Use

If you choose to share your SG-OCRA™ results with an insurer or third party, such sharing will occur only with your explicit consent. Results may be used for wellness, screening, or preventive health purposes and will not be used for exclusionary underwriting or adverse decisions unless separately agreed.

Limitations of the Test

SG-OCRA™ provides risk information, not a confirmed diagnosis. A high-risk result does not confirm disease, and a low-risk result does not rule it out. Clinical evaluation and follow-up are required.

Acknowledgement

By clicking “I Agree”, you confirm that you:

1. Have read and understood this Informed Consent.
2. Understand the purpose, benefits, and limitations of the SG-OCRA™ test.
3. Voluntarily consent to sample collection, data processing, and result reporting.