Published: 15 June 2023
A new multi-cancer early detection blood test could speed up diagnosis.
The test is called Galleri. It correctly identified two thirds of cancers in more than 5,000 people who visited their GP with non-specific symptoms that may be a result of cancer. It also pinpointed the original cancer site in 85% of those cases.
SYMPLIFY is the first large-scale evaluation of a multi-cancer early detection (MCED) test. It was supported and delivered by the National Institute for Health and Care Research (NIHR).
Researchers from the University of Oxford presented at the American Society of Clinical Oncology (ASCO) conference in Chicago. The results are due to be published in the Lancet Oncology.
How does the cancer blood test work?
Galleri can detect over 50 types of cancers with a single blood draw. Forty-seven of these cancers lack recommended screening in the UK today.
The test detects tiny fragments of cancer DNA in the bloodstream. It was developed by US biotechnology company GRAIL.
People taking part in the SYMPLIFY study had their diagnostic tests in the normal way. They also gave a blood sample, which was later compared against their health record.
The Galleri test detected a cancer signal in 323 people - 244 of whom were diagnosed with cancer. Overall, 368 patients of the 5,461 evaluable patients were diagnosed through standard of care.
Patients in the study were either referred for tests for possible gynaecological, lung, lower or upper gastrointestinal cancers, or had non-specific symptoms that could be caused by cancer.
Earlier diagnosis and fewer tests
Diagnosing cancer can take time and involve many expensive tests or invasive biopsies. Especially when symptoms are non-specific and could be caused by other conditions.
Galleri has the potential to simplify this process and find cancer earlier - when treatment is more likely to be successful.
Professor Mark Middleton, former cancer co-theme lead at NIHR Oxford Biomedical Research Centre and co-lead investigator on the study, said: "The test was 85% accurate in detecting the source of the cancer - and that can be really helpful because so many times it is not immediately obvious when you have got the patient in front of you what test is needed to see whether their symptoms are down to cancer.
“With that prediction from the test, we can decide whether to order a scope or a scan and make sure we are giving the right test the first time."
Delivering research at scale
SYMPLIFY was funded by GRAIL with support from National Health Service (NHS) England, NHS Wales and NIHR. The University of Oxford led the study and was responsible for data collection, analysis and interpretation.
SYMPLIFY was supported by the NIHR Oxford Biomedical Research Centre. The NIHR Clinical Research Network carried out recruitment at 43 sites.
Professor Helen McShane, Director of the NIHR Oxford Biomedical Research Centre, said: “This is a fantastic example of how academia and industry can work together for patient benefit, recruiting over 6,000 patients to SYMPLIFY in under six months and within less than a year of launching the project.
“We are committed to diagnosing cancers earlier, when they can be cured, and this study is an important step on that journey. SYMPLIFY also shows that we can run trials at scale using digital systems to deliver research quickly and cost effectively, with the help of the NIHR Clinical Research Network.”
What’s next?
The SYMPLIFY study is one of two large UK-based clinical trials funded by GRAIL, the other being the NHS-Galleri trial.
Depending on the results, the test could be used in future in routine visits to the GP, or to complement existing tests and screening programmes.
Sir Harpal Kumar, President of GRAIL Europe, said: “GRAIL’s earlier PATHFINDER study demonstrated that adding GRAIL’s MCED testing to standard of care screening more than doubled the number of cancers detected compared with standard screening alone in adults with no symptoms or suspicion of cancer.
“Now, the SYMPLIFY data confirm the potential benefit of methylation-based MCED blood tests as a diagnostic aid for use in the symptomatic patient population. These exciting results will inform our development of an optimised classifier for use in symptomatic patients with a suspicion of cancer.”