GlyHealth Research Services/ Research and Development

Project name: Blood plasma glycan traits of health and disease across different ethnic populations.

Principal Investigator: DrĀ Daniel I R Spencer

Organisation: Ludger Ltd and Avenna Ltd

Email: Daniel.Spencer@ludger.com and info@avenna.com

Purpose of the Research


What is the Research Project?

Glycosylation is one of the most essential processes occurring in the human body, contributing to its correct functioning. It is present on more than half of all proteins, which are the main structural and functional biomolecules in nature. Technically, glycosylation consists of the addition of individual sugar units to protein fragments, to build up long chains of sugar molecules (glycans), resulting in very specific and strictly defined structures. It is critical for a wide range of biological processes, as it regulates the interaction of the molecules, and cells they are attached to, with the surrounding environment. As such, glycans are involved in virtually every biological process in the human body, from fertilization and embryogenesis, through cell proliferation, differentiation and development, to immunity and aging.

Glycosylation carries valuable information about the processes occurring inside the human body. However, many of the correlations between glycosylation and individualsā€™ health and lifestyle factors have not been studied before and remain undiscovered. Ludger is studying the associations between different glycosylation features, abnormalities and differences in blood plasma glycosylation profiles between individuals, in order to better understand those correlations. In the future, this research could contribute to the expansion of glycan biomarker panels for each individual, allowing for more personalised health advice and treatment. This approach is commonly known in medicinal sciences as ā€˜precision diagnosticsā€™ or ā€˜precision medicineā€™.

Our overarching goal for this project is to discover novel glycan biomarkers which can be used as a prodromal signal for inflammatory diseases. Ā We are looking how particular glycan structures can be an early-warning molecular signals for chronic inflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease and acute inflammatory diseases such as COVID-19. We are also looking at non disease specific glycan biomarkers which can determine health risks and personal predispositions to disease, and identification of individualsā€™ response to treatment.

How do I Participate in the Project?

You have already decided to give a blood sample in order to obtain your GlyHealth Index. If you agree to this consent document, the researchers will be able to use the information obtained from your sample, along with your self-reported information obtained during the service registration process, for research purposes. All the information will be anonymised and combined with other peopleā€™s results when disclosed to the wider public.

There is no additional financial cost to you, neither additional effort other than accepting this consent document, to be able to participate in the project. Whether or not you decide to participate in the project, you will be asked to accept the GlyHealth service Terms & Conditions.

What Information will be Collected? How will the Information be Used?

Ludger and Avenna will collect, preserve and analyse the following information as part of this research project: general information (e.g. date of birth, gender, ethnicity), health-related information provided by you prior to giving consent (e.g. medical conditions, diseases), lifestyle information may be provided by you retrospectively or collected as part of this study (e.g. sleep patterns, movement/activity data) and your glycosylation analysis results (e.g. GlyHealth Index). Your name and contact information will NOT be subject of research but will be stored securely for the purpose of unique sample identification. Any other sensitive personal information (e.g. credit card details, used ID, passwords) will NOT be stored or analysed as part of research.

Your glycosylation analysis results along with the information provided by you (self-reported information) will be used for research purposes ā€“ which includes discovery of new traits and correlations between glycosylation profiles and health/chronic inflammation status /inflammatory disease status. Our discoveries may be published in scientific journals or disseminated to the scientific community in other ways (e.g. presentations and talks during scientific events), as well as used as marketing material. In such cases anonymised information, and information combined with other peopleā€™s results will be made public, and your personal information will remain private.

There are clinical methods for measuring acute inflammation in patients known as CRP (C-reactive protein). We would like to see if there is correlation between chronic inflammation as found by the GHI test and acute inflammation as found by the CRP test. For the CRP measurement: C-reactive protein will be measured using a high sensitivity enzyme linked immunosorbent assay (ELISA) acquired from Invitrogen and compared against internationally recognised determinations of CRP levels representative of patients with non, minor and major chronic inflammation levels. To gain CRP levels we will use the same blood samples that are collected using the Lancet puncture method.

Benefits and Risks of Participation


Benefits

The main goal of our research is to make meaningful scientific contribution in a field of precision medicine. By qualifying our customers to participate directly in the study, we enable them to contribute to the success of the project. This project is intended to assist us and other researchers to better understand the glycan features associated with health and wellbeing, as well as aging and disease to determine novel biomarkers. Participating in this project may not benefit you directly, however it is possible that our discoveries will contribute to expanded health assessment services in the future. The more information contributed to the project, the better the potential results could be and better clinical tools can be developed and integrated in healthcare ecosystem for IDs. Additionally, if Ludger and Avenna publishes the study results in peer-reviewed journals, there will be added benefits for the wider research community.

There is no additional financial cost to you, neither additional effort from your side for allowing the information from this analysis to be used in the project. The blood sample you provide will be analysed to provide the GlyHealth Index to you regardless of whether or not you decide to participate in the project.

Based on the results of this study, Ludger and Avenna may develop intellectual property and/or commercialise products and services. In such cases you will not receive any financial compensation. We will own the results of the project and any subsequent publication of the results.

Risks

Your test results may reveal information about certain health conditions and predispositions, however there are no physical risks for providing a blood sample and having your sample and information used in this project. While our discoveries and the self-reported information may be shared through scientific publication or within the research community in generalised form, this will not contain any personal information, or the information that permits identification of you, such as your name and contact details. Also, research project results will not be communicated by Ludger Ltd directly to you or any physician.

As the GlyHealth service is in the initial stages of validation, any result provided to you may be delayed pending completion of any final validation required.

We work towards protecting your personal information. However, data can be stolen in the unlikely event of an incidental security breach, which may reveal your results associated with your personal information to the general public. This can happen whether or not you decide to participate in the research.Ā  However, we would like to assure that we have strong data security policies and comply with industry standards for data security to minimise the possibility of a breach. Our data protection practices are detailed under ā€˜Data Confidentialityā€™ section.

There may also be additional risks to participation that are currently unforeseeable.

Data Confidentiality


Data protection

Your personal information, your GlyHealth results and the information obtained from this research will be stored electronically in the United Kingdom, with all the data being securely backed up to an online server to avoid data loss. We use a range of physical, technical, and administrative procedures and follow industry standard protocols to protect the privacy of the information. Access to our databases and data centre is restricted by passwords, pass cards and encrypted Internet connections, and all the servers have firewall protections in place. Transfer of the personal information is protected by encryption.

Who do we share the data with?

Access to personal information (such as your name and contact details) will be restricted to specifically authorised individuals closely working on the research project. Similarly, any document containing your information and any sample provided by you will be identified with a code and not your name, to limit the number of individuals having access to your personal data. Any personal information, or any information that would allow identification of you as an individual (direct identifiers), will not be disclosed externally. When we collaborate with external third parties as part of the project, these parties will only have access to pooled information from which direct identifiers have been removed. We will never purposely release any personal information without asking for and receiving your explicit authorization to do so, except as required by law.

If you agree to this consent document, Ludger can use the information you have provided, along with the results from the analysis, for research that may be published in scientific journals or disseminated to the scientific community in other ways (e.g. presentations and talks during scientific events). In such cases, your identity along with your direct identifiers will not be disclosed by us in any case and your privacy will be protected.

What will Happen to my Sample?


Your blood plasma sample will be stored in our labs in the United Kingdom. Your sample will not be labelled with your name or other directly identifying information. Instead, it will be identified with a code. The list that matches the code with your name and information will be stored separately from your sample. Your sample will be kept indefinitely unless you ask the researchers to destroy it.

Can I Withdraw from the Study?

Participation in this project is purely voluntary. At any time, you may choose to withdraw our right to use some or all of the information you have provided by sending a request to info@Ludger.com. We will cease using the information you have provided for the project and any future studies promptly after receipt of your request. There will be no penalty to you, and you will continue to be able to use our services as before. Any research using your information that has already begun, studies that have been performed completely, and any study results or findings that have been published prior to this date cannot be reversed, undone, or withdrawn.

In addition, the research study can be terminated at our discretion without your consent. Your personal information will be kept private even after project is terminated or the data you provide is no longer in use.

Ā 

Who Can I Contact in Case of Questions?

If you have any general questions or concerns about the research study, or if you have a question about subjects’ rights, please contact us via email or post:

Ludger Ltd

Culham Science Centre

Oxfordshire

OX14 3EB

UK

info@avenna.com