SUMMIT Study: Cancer screening study with or without low-dose lung CT to validate a multi-cancer early detection test (Previously ODR1718_316)

University College London (UCL) and GRAIL, Limited Liability Company (LLC) are requesting NHS Digital record level data for the Study: "SUMMIT: Cancer screening study with or without low-dose lung CT* to validate a multi-cancer early detection test"

(*low-dose computed tomography (also called a low-dose CT scan, or LDCT) is a screening test for lung cancer. During an LDCT scan, you lie on a table and an X-ray machine uses a low dose (amount) of radiation to make detailed images of your lungs. The scan only takes a few minutes and is not painful.)

Data for this study has previously been shared when the data were controlled and managed by Public Health England (PHE). PHE facilitated data release via its Office of Data Release service (ODR). ODR was responsible for providing a common governance framework for responding to requests to access PHE data for secondary purposes, including service improvement, surveillance and ethically approved research. All requests to access data were reviewed by the ODR and were subject to strict confidentiality provisions. The responsibility for the management of the National Disease Registration Service of which the National Cancer Registration and Analysis Service is a part, transferred from PHE to NHS Digital on 1st October 2021. The SUMMIT study previously accessed data via Public Health England under the reference: ODR0718_316.

MAIN AIM AND PURPOSE OF SUMMIT

The SUMMIT Study aims to understand ways to detect lung cancer before there are any symptoms, when treatment can be simpler and more successful.

The SUMMIT Study is a prospective cohort study of approximately 13,000 participants from London designed to investigate how cancer screening can be improved and delivered. The study will recruit individuals at high risk for cancer, especially lung cancer, due to significant smoking history. The study has two main aims:

1. To develop and evaluate the performance of the GRAIL blood test for the detection of multiple cancer types and the identification of tissue of cancer origin

2. To examine the performance and feasibility of delivering a low dose CT (LDCT) screening service for lung cancer to a high-risk population in London and the surrounding area.

***THIS VERSION (v1): OCTOBER 2022***

This is a request to Renew and Amend a Data Sharing Agreement (DSA) with University College London (UCL) and GRAIL, LLC.

STUDY AIMS

The data requested are key to the SUMMIT Study, as it will allow the study team at UCL to understand what types of cancers the participants may develop during the course of, and after LDCT screening. Thereby identifying what types of cancer signals may be present in participants blood. The data requested will also allow the study team to analyse the performance of LDCT screening. LDCT screening has been shown to reduce lung-cancer mortality in at-risk populations by 20-26% and it is hoped that by demonstrating the feasibility of LDCT screening it will enable the study team to make a case for the adoption of a UK national lung cancer screening programme, vastly improving lung cancer outcomes. Similarly the development of a blood test (Galleri Test) for screening would reduce morbidity and mortality for many types of cancers through early detection.

Both GRAIL and UCL blood samples are taken from consenting patients during the SUMMIT study. Genetic testing is being performed by GRAIL, LLC on the samples taken for the purpose of developing the blood test to detect cancer early. UCL may also conduct genetic testing on the samples taken and stored by UCL, however the purpose of this will not be to develop a blood test to detect cancer, but for the purpose of research into lung, cardiac and other diseases. This information is provided to participants on the Patient Information Sheet and Informed Consent form which have received ethical approval from the London - City & East Research Ethics Committee.

NEW DATA REQUESTED

UCL and GRAIL, LLC are requesting further access to the following National Cancer Registration and Analysis Service (NCRAS) National Disease Registration Service (NDRS) datasets (formerly available via Public Health England (PHE):

- NDRS Rapid Cancer Registrations

- NDRS Cancer Registry

- NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

- NDRS National Radiotherapy Dataset (RTDS)

- NDRS Linked HES Admitted Patient Care (APC)

- NDRS Linked HES Outpatient (OP)

- NDRS Somatic Molecular Dataset

- Emergency Care Dataset (ECDS)

- NDRS Linked Diagnostic Imaging Dataset (DIDS)

- NDRS National Lung Cancer Audit (NLCA)

How the data requested will achieve the study aims:

The NDRS Rapid Cancer Registry data and NDRS Cancer Registry data are requested to clinically validate a cell-free nucleic acid (cfNA) based GRAIL blood test for early detection of multiple types of cancer, including lung cancer and also investigate how low dose CT lung cancer screening can be improved and delivered. The additional datasets ECDS, DIDs, HES APC, HES OP, NLCA, RTDS Somatic Molecular Dataset and SACT will all be used for these aims as well as to answer the secondary endpoints of the study including, investigation of the uptake of LDCT screening (and demographic and psychological characteristics of this), examining the harms associated with LDCT screening, and to explore the outcomes following lung cancer screening and subsequent treatment.

All elements of the GRAIL test will be pre-specified prior to combining the assay results with the clinical data including the classifier and the cut-points for defining positive vs negative results. In addition the data should inform on efficient implementation of an LDCT screening service to detect early-stage lung cancer among current and former smokers. This includes understanding important operational parameters such as screening interval, uptake and adherence, and also psychosocial issues such as psychological impact and harms and quality of life measures.

NHS Digital pseudonymised record level data (linked to SUMMIT study ID) from consented participants are required to link to the Galleri Test and LDCT scan test results obtained within the study at participant study visits. In this agreement, NDRS NCRAS data is requested 6 months (183 days) prior to the date the participants consented up to around Winter 2027 (with monthly data drops until December 2023 and then quarterly until the end date of this agreement). The Cancer Registry provide historical cancer data dating back to 1995. Ascertaining the historic cancer diagnosis background of each study participant is important as a historic diagnosis may impact SUMMIT test results or treatment decisions.

The SUMMIT study is currently scheduled to last until 10 years after the last participant was enrolled in the study (last participant enrolled 14/05/2021) at which point the end of study will be declared. An extension to the NDRS Cancer Registry Dataset may be requested in the future to coincide with the end of the study.

Long term follow up data is required to ensure any cancers identified after/outside of SUMMIT LDCT screening or developing late can be linked to any potential biomarkers of cancer in the Galleri blood test or any early radiological signs at screening. In addition, long term follow up data (such as recurrence data) can be assessed alongside radiological parameters collected at LDCT screening (for example assessing whether radiological growth rates can predict post treatment outcomes).

PREVIOUSLY HELD DATA

To note: The study team at UCL currently hold data which was collected via PHE (under ODR0718_316).

The Data sharing contract between UCL and Public Health England (which transferred to NHS Digital via novation agreement on 13/12/2021) granted UCL access to cancer registration data from a bespoke ‘early ascertainment’ dataset. In this version of the agreement (v1) the study team wish to transfer from receiving the Early ascertainment dataset over to the Rapid Registry Dataset. Additionally, the study team also request that GRAIL, LLC and GRAIL Bio UK Ltd are permitted access to the ‘early ascertainment’ datasets which UCL already hold. These datasets will be transferred from UCL to GRAIL, LLC and GRAIL Bio UK Ltd in the same way as described for the NDRS NCRAS datasets applied for in this agreement.

It is hoped that the ODR Early Ascertainment datasets, NDRS Rapid Registry Dataset and NDRS Cancer Registry dataset can all be used to inform on future work related to the development of the blood test to detect cancer early and also for the implementation of a UK National Lung Cancer Screening programme. This work will follow on from the SUMMIT study.

Cancer Research UK (CRUK) provides core funding to UCL Clinical Trials Unit (CTU). All employees working for 'Cancer Research UK and UCL Centre Trials Centre' (UCL CTC) are substantive employees of UCL and not employed directly by CRUK. CRUK does not have direct impact on how the SUMMIT study is to be run, and no CRUK employees will be able to view, access or process any NHS Digital record level data, and are therefore not included as a Data Processor on this agreement.

COMMON LAW DUTY OF CONFIDENTIALITY

The study team at UCL will be providing one cohort for this request containing approximately 13,000 individual records.

Consent to data linkage has been sought for all participants in the study. NHS Digital will not apply National Data Opt-Out for these participants and are content that the consent materials are compatible with the flow of data described in this agreement.

LAWFUL BASIS FOR THE PROCESSING OF PERSONAL DATA (GDPR)

University College London is relying on GDPR Article 6 (1)(e): processing is necessary for the performance of a task carried out in the public interest, and additionally (as health data is a special category or Personal Data), Article 9(2)(j): processing is necessary for the archiving purposes in the public interest, scientific or historical research purposes. Participants that lack capacity to provide fully informed consent were not included in the SUMMIT study and consultee consent was not permitted. Data minimisation processes are being followed and only data that is required specifically for the purposes of this study has been requested, to protect the rights of the data subjects. In addition data will not be collected from participants that have withdrawn their consent to future data collection.

GRAIL LLC is using GDPR Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for GRAIL, LLC’s legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests. GRAIL, LLC has completed a legitimate interests assessment (LIA). The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. Additionally (as health data is a special category of Personal Data), GRAIL, LLC is also relying on Article 9(2)(j): special category data used for “archiving in the public interest, scientific or historical research or statistical purposes,” with a basis in law. The data in the SUMMIT study is being requested to be used in the public interest, as the SUMMIT study aims to understand ways to detect lung cancer before there are any symptoms, when treatment can be simpler and more successful. If the study team are successful in their endeavours, this intervention could be brought to a wider UK population, thereby vastly improving lung cancer outcomes for UK patients and benefiting the NHS.

PATIENT AND PUBLIC INVOLVEMENT (PPIE):

The acceptability of the SUMMIT study has been discussed with and approved by PPIE and General Practitioner (GP) groups, who have been involved throughout the design and running of the study.

There have been three separate SUMMIT specific face-to-face PPIE sessions, with different members in each session. These members were representative of the group being invited to this study (i.e. smokers and former smokers in the eligible age bracket). The earlier sessions discussed the design and concept of the study, particularly the invitation process. The later sessions were extremely focused and looked in detail at the Participant Information Sheet (PIS), consent form and other documents including the collection and processing of personal data. This group also looked at invitation and results letters sent to the participants in order to report back the results of their LDCT scans. All feedback received from both PPI members and GPs has been considered and incorporated appropriately into the study design.

It was important to get input from a diverse PPI group and these included:

• Eleven attendees plus one phone feedback.

• Nine of the attendees were males and three were females (including phone feedback)

• Cancer patients – 5 of them have received or are currently receiving treatment for cancer but not lung cancer

• Smoking history – 8 of the attendees were either light or heavy smokers

• Three attendees work in the construction industry

• Four attendees are members of the UCLH Cancer Patient and Public Advisory Group

• Two people indicated that they have caring responsibilities for a family member or friend with a cancer diagnosis

The study team have two PPIE members on the Project Steering Group and also a centralised UCL Cancer Trials Centre (CTC) PPIE group to call upon when needed. These members have continued to assist the SUMMIT team understand and accommodate the public perspective on LDCT screening, sampling and data processing throughout the duration of the study. The PPIE members will also be key in interpreting and disseminating the study results.

Organisation Roles and Responsibilities:

The SUMMIT study is an academic study sponsored by UCL and funded by, and run in collaboration with GRAIL, LLC.

• UCL are a joint data controller and lead for this agreement, who also process the data and are responsible for sending participant identifiers to NHS Digital for data linkage and for receiving NHS Digital record level data, downloading onto the Data Safe Haven and sharing with GRAIL, LLC.

• GRAIL, LLC are a joint data controller who also processes the data and are responsible for receiving NHS Digital pseudonymised record level data and sharing with GRAIL Bio UK Ltd.

• GRAIL Bio UK Ltd will be receiving pseudonymised record-level NHS Digital data via GRAIL, LLC and are therefore listed as a Data Processor in this agreement.

NOTE: GRAIL, LLC is the successor in interest to GRAIL, Inc. GRAIL, LLC encompasses all GRAIL locations including GRAIL Bio UK Ltd which is also a data processor located in the UK. GRAIL Bio UK Ltd were not in existence when SUMMIT was set up and open to recruitment. It is agreed by UCL and GRAIL that from the participant information sheet and consent documentation that participants would be aware that their data would be processed by GRAIL encompassing both locations.

For full transparency of the Commercial element of this agreement, it is noted that GRAIL LLC and/or GRAIL Bio UK Ltd may take the results of the SUMMIT study to further refine the algorithm of their MCED test that could add commercial value to their product(s). Therefore in the future, GRAIL LLC and/or GRAIL Bio UK Ltd may receive commercial benefit (including intangible or indirect commercial benefits such as positive publicity) from the successful outcomes of the trial.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract). There will not be any access to the data by any third parties.

This application is to request the renewal and amendment of data previously provided under the agreement with the Office for Data Release ODR0718_316.

DATAFLOW

The data flow outlines the high level workflow for how data flow occurs between UCL, GRAIL LLC, GRAIL Bio UK Ltd and NHS Digital for the SUMMIT study. The flow covers two key steps:

1. Transfer of linkage file/identifiers from UCL to NHS Digital.

2. Transfer of linked data from NHS Digital back to UCL, GRAIL LLC and GRAIL Bio UK Ltd.

Transfer of linkage file/identifiers from UCL to NHS Digital:

• UCL will send the list of Patient Identifiable Data (PID) - including participant Study ID, NHS Number, Gender, Date of Birth and Postcode - securely to NHS Digital via a Secure Electronic File Transfer Service (SEFT) or other secure, NHS Digital approved file transfer mechanism. This identifiable data is stored in the SUMMIT Clinical Records Management system (“SCRMS”). This list will only include participants that have consented to SUMMIT and have not withdrawn their consent for future data collection. This is to ensure that participant’s rights to object are respected and to abide by data minimisation principles.

• The NHS Digital data production teams will link patient identifiers to the datasets requested in section 3.

• The NHS Digital production team to remove patient identifiers from the linked data to mitigate any risk of reidentification of participant data.

Transfer of linked data from NHS Digital back to UCL, GRAIL LLC and GRAIL Bio UK:

• NHS Digital transfers the data via SEFT or other secure, NHS Digital approved file transfer mechanism. This data is pseudonymised (only the Study ID from the linkage transfer is kept and identifiable fields are removed).

• UCL team downloads the data onto the UCL Data Safe Haven (DSH) (see below).

• GRAIL, LLC has a UK-specific, permission controlled and encrypted AWS S3 bucket created. A UCL user is designated and given access by the GRAIL team to transfer data from the DSH to this S3 bucket to GRAIL, LLC.

• Once the data is in the S3 bucket, it is replicated to the US and a copy can be ingested into the GRAIL, LLC analysis pipeline.

• GRAIL LLC can then provide the pseudonymised data set to GRAIL Bio UK via a separate AWS S3 bucket.

• UCL, GRAIL, LLC and GRAIL Bio UK Ltd will have a copy of the same dataset.

• Pseudonymised dataset is available in a permission-controlled manner to GRAIL study team users.

STORAGE AND PROCESSING LOCATIONS

Amazon Web Services (AWS UK) supply IT infrastructure for GRAIL Bio UK Ltd and are therefore listed as data processors. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. AWS UK use only UK data centres and provides a private cloud platform which hosts the Clinical Records Management System (“CRMS”) which was developed by GRAIL, INC (now GRAIL, LLC) and is currently managed by GRAIL Bio UK Ltd. The record-level pseudonymised data extracts referred to in section 5a (above) will be stored in secure S3 folders which are hosted on Amazon Web Service (AWS UK). The PID will be stored separately in the CRMS and is the main PID used to invite and book patients into study appointments . Only authorised study team members of GRAIL Bio UK Ltd and UCL have access to NHS Digital record-level pseudonymised data and PID data stored in the secure S3 folders hosted by AWS in the United Kingdom. Enrolled participants also consent to the transfer and storage of their health data to Grail Bio UK Ltd for the purposes of processing the pseudonymised data extracts for this application.

Amazon Web Services, Inc (USA) supply IT infrastructure for GRAIL, LLC and are therefore listed as data processors. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. Enrolled participants also consent, as expressly stated in the consent form and participant information sheet, to the transfer of their pseudonymised health data to GRAIL, LLC in the US for purposes permitted by the study participant consent form. The pseudonymised data will be transferred by UCL from the UCL Data Safe Haven to a secure S3 folder hosted on Amazon Web Services, Inc. (USA). The transfer will be undertaken using a secure, encrypted network connection.

The UCL Data Safe Haven (DSH) is a safe haven system which conforms to NHS Digital’s Information Governance Toolkit. Access is via a remote desktop arrangement served via Citrix. Access is controlled via the use of a username, password, PIN and one-time token-based password. The token-based password is generated algorithmically and is changed every minute. Access will only be granted to substantive UCL employees for the purpose of processing outlined in the section above. The data analyses the performance of screening delivery (e.g. uptake and factors that affect uptake) will be undertaken by statisticians at UCL all using pseudonymised data. The Data Safe Haven is subject to external professional penetration testing on an ongoing basis. Failed logon attempts are recorded in the Data Safe Haven system and are managed by the Data Safe Haven Service Operation Manager. Intrusion attempts and port scans are detected and reported to the UCL security function for investigation as necessary. Data is transferred into the system via a secure gateway technology and is then retained via policy and systems that prevent data leakage (for example, through transfer of data to USB media or copy and paste to the client machine). Whilst using the DSH users are prevented from accessing any external network resources (web sites, email, etc). The SLMS Data Safe Haven is certified to ISO 27001:2013. Limited PID is also stored in the DSH for the purposes of SUMMIT research and NHS-D data linkage, this includes Date of birth, Age, GP practice name, NHS number, Postcode, Gender, Ethnicity, IMD score and rank and smoking status. This is stored securely in the UCL DSH, access to which is carefully controlled and only those that have permission to view this PID have access to the UCL data safe haven. Those that do not have permission to access PID will not be able to access to the DSH where the data linkage documents are stored and will not be able to link the data to a specific patient.

Data analysis related to the Galleri Blood test will led by one of GRAIL’s senior bio-statistician/bio-informaticians (employed by the funder, GRAIL LLC), in the US and UK, all using pseudonymised data. Data may be transferred by GRAIL LLC to GRAIL Bio UK.

Data processing will only be carried out by substantive employees of UCL, GRAIL, LLC and GRAIL Bio UK Ltd. All employees with access to NHS Digital Record level data have been appropriately trained in data protection and confidentiality.

The ultimate result of the data processing for the SUMMIT study is to develop a blood test to detect cancer early and also implement a national LDCT lung cancer screening programme in the UK.

The expected outputs include submission to peer-reviewed journals, conferences and presentations. The planned journals include; Lancet respiratory medicine, Lancet oncology, European Respiratory Journal and Annals of Oncology.

The first primary outputs are expected in with the target end date of 2023/mid-2024. The study team intend to release further publications once the data matures and more NDRS NCRAS data is received. Primary outputs will be linked to study endpoints:

• To examine LDCT screening delivery using established measures of performance and risk prediction.

• To quantify the uptake of LDCT screening, and examine the demographic and psychological characteristics and smoking status of those who consent to be screened.

• To examine adherence to and practicability of a biennial LDCT versus annual screening.

• To identify the psychological and screening-related factors which predict uptake of, and repeat adherence to, LDCT screening for lung cancer, as well as their sociodemographic and smoking-related correlates.

• To investigate QoL over time, to explore associations with screening adherence, the frequency of screening and abnormal LDCT results.

• To examine the harms associated with LDCT screening.

• To evaluate the performance of the GRAIL test for the detection of lung cancer within 12 months of Y0, Y1 and Y2 timepoints.

• To evaluate the performance of the GRAIL test for the detection of invasive cancer and identification of tissue of cancer origin within 12 months of Y1 and Y2 timepoints.

• To evaluate the performance of the GRAIL test for the detection of invasive cancer and identification of tissue of cancer origin within 24 months of Y0 and Y1 timepoints.

• To evaluate the performance of the GRAIL test by cancer type, stage and method of diagnosis.

• To evaluate association of the GRAIL test result and cause-specific survival (e.g. cancer, cardiovascular) and overall survival.

The plan is to disseminate aggregate results (with small numbers supressed according to the HES Analysis Guide) to public and patient communities, for example on the UCL CTC website, Cancer Research UK (CRUK) website, clinicaltrials.gov and via the HRA Final Report. The study team also plan to send a newsletter summarising the results in lay language for all participants that have taken part in SUMMIT. Newsletters will be reviewed by the SUMMIT PPIE members and by the UCL CTC PPIE group before submission to REC for review. The study team also intend to include the PPIE group in any other dissemination activities within patient groups, such as lung cancer charities, conferences and PPIE Open days.

In addition the outputs of data processing at the end of the study aim to include conference abstracts, reports to NHS England and GRAIL, and submissions of SUMMIT findings to peer reviewed journal(s). The publications will not contain the data, only the results of its statistical analysis that will be summarized overall.

GRAIL may take the results of the SUMMIT study to further refine the algorithm of their MCED test that could add commercial value to their product(s).

Analysis of interim study data has already been published in various journals (see below), posters presented at BTOG 20/22, World Lung 19/20 and ERS 22, and abstracts submitted to BTS 20 and ATS 21:

- Horst C, Dickson JL, Tisi S, Ruparel M, Nair A, Devaraj A, Janes SM. Delivering low-dose CT screening for lung cancer: a pragmatic approach. Thorax 2020;75:831-832.

- Quaife SL, Waller J, Dickson JL, Brain KE, Kurtidu C, McCabe J, Hackshaw A, Duffy SW, Janes SM. Psychological Targets for Lung Cancer Screening Uptake: A Prospective Longitudinal Cohort Study. J Thorac Oncol. 2021 Dec;16(12):2016-2028.

- Dickson JL, Hall H, Horst C, Tisi S, Verghese P, Mullin AM, Teague J, Farrelly L, Bowyer V, Gyertson K, Bojang F, Levermore C, Anastasiadis T, Sennett K, McCabe J, Devaraj A, Nair A, Navani N, Callister ME, Hackshaw A; SUMMIT Consortium, Quaife SL, Janes SM. Telephone risk-based eligibility assessment for low-dose CT lung cancer screening. Thorax. 2022 Jul 21:thoraxjnl-2021-218634.

- Dickson JL, Bhamani A, Quaife SL, Horst C, Tisi S, Hall H, Verghese P, Creamer A, Prendecki R, McCabe J, Gyertson K, Bowyer V, El-Emir E, Cotton A, Mehta S, Bojang F, Levermore C, Mullin AM, Teague J, Farrelly L, Nair A, Devaraj A, Hackshaw A, Janes SM; SUMMIT consortium. The reporting of pulmonary nodule results by letter in a lung cancer screening setting. Lung Cancer. 2022 Jun;168:46-49.

A newsletter has also been disseminated to participants in June 2021 providing an update on the study’s progress.

Demonstrating the feasibility of LDCT screening for lung cancer should enable the study team to add to the evidence needed to establish a national screening programme in the UK. By successfully carrying out the SUMMIT study, the study team could bring this intervention to a wider UK population, thereby vastly improving lung cancer outcomes. Should a national lung cancer screening programme go ahead, SUMMIT will also be able to provide valuable information to shape this programme. This includes improving current lung cancer risk models (such as Prostate, Lung, Colorectal and Ovarian risk (PLCO)), finding optimal invitation strategies, understanding the demographic and psychological characteristics of participants undergoing screening, optimising screening processes, and also informing how best to implement LDCT screening (e.g. annually vs biannually). It is hoped that this data will improve the uptake and efficiency of future screening programmes and increase the accuracy and sensitivity of lung cancer detection of those participating, ultimately improving treatment outcomes and survival.

As the largest population based LDCT screening study in the UK, the SUMMIT Study continues to be of considerable public benefit; both directly through screening high-risk adults for lung cancer and indirectly through answering outstanding questions the national screening committee have on how to implement LDCT screening in future UK screening programmes. SUMMIT has also helped direct and inform the NHS England commissioned Targeted Lung Health Check programme currently being implemented. Many of the key points learnt from running SUMMIT will be implemented into the roll out of this programme at UCLH.

In the medium term, the development of an early cancer blood test will provide improved cancer screening and earlier diagnosis. A minimally invasive, relatively inexpensive blood test to detect multiple types of cancer will be invaluable to future healthcare worldwide where cancer can be detected earlier when it can be better treated and cured. It is expected that the Galleri test will also predict the origin of the cancer signal with high accuracy to help guide diagnosis. Using the Galleri test alongside existing screening tools is expected to improve early cancer detection for patients at an elevated risk of cancer, such as those aged 50 or older.

Through implementation of LDCT lung cancer screening and a blood test to detect cancer, most patients should be diagnosed earlier that they would otherwise be, with an expected decrease in cancer stage for patients presenting in cancer clinics (a general downshift in cancer stage). Although it is understood that an earlier diagnosis might not benefit every patient, in the majority of cases most cancers will be detected and treated earlier where treatment success and survival rates are better. The 1-year survival rates based on cancer stage between 2013-2017 are below (data from CRUK):

- Stage 1: 87.2%

- Stage 2: 73.0%

- Stage 3: 48.7%

- Stage 4: 19.3%

There are no current yielded benefits from receipt of the Early Ascertainment data to document as yet.