A National Health Service (NHS) trial of a new blood test for more than 50 types of cancer has shown promise after it correctly revealed two out of every three cancers in people who had visited their general practitioner (GP) with suspected symptoms in England or Wales, the University of Oxford researchers said on Friday.
The so-called Galleri test also correctly identified the original site of cancer in 85 per cent of those cases in what has been described as the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented to their GP for diagnostic follow-up for suspected cancer.
The SIMPLIFY study enrolled 6,238 patients, aged 18 and older, who were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible gynaecological, lung, lower GI or upper GI cancer, or who had presented with non-specific symptoms.
New tools that can both expedite cancer diagnosis and potentially avoid invasive and costly investigations are needed to more accurately triage patients who present with non-specific cancer symptoms, said Brian D Nicholson, Associate Professor at Oxford University's Nuffield Department of Primary Care Health Sciences and co-lead investigator of the study.
The high overall specificity, positive predictive value, and accuracy of the cancer signal detected and cancer signal origin prediction that was reported across cancer types in the SYMPLIFY study indicate that a positive MCED test could be used to confirm that symptomatic patients should be evaluated for cancer before pursuing other diagnoses, he said.
Participants provided a blood sample, from which DNA was isolated and tested. Most patients diagnosed with cancer in England and Wales first see a primary care physician for the investigation of symptoms suggestive of cancer.
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The most commonly reported symptoms leading to referral were unexpected weight loss (24.1 per cent), change in bowel habit (22.0 per cent), post-menopausal bleeding (16.0 per cent), rectal bleeding (15.7 per cent), abdominal pain (14.5 per cent), pain (10.6 per cent), difficulty swallowing (8.8 per cent) and anaemia (7.1 per cent).
This study is the first step in testing a new way to identify cancer as quickly as possible, being pioneered by the NHS earlier detection of cancer is vital and this test could help us to catch more cancers at an earlier stage and help save thousands of lives, said NHS national director for cancer Professor Peter Johnson.
The University of Oxford sponsored the SYMPLIFY study and was responsible for data collection, analysis and interpretation.
The study was funded by US healthcare company GRAIL which has developed the Galleri blood test with support from NHS England, NHS Wales, the National Institute for Health and Care Research (NIHR) and NIHR Oxford Biomedical Research Centre.
GRAIL's earlier PATHFINDER study previously demonstrated that adding GRAIL's MCED testing to the 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, said Sir Harpal Kumar, President of GRAIL Europe.
These exciting results will inform our development of an optimised classifier for use in symptomatic patients with a suspicion of cancer, he said.
The findings of the SYMPLIFY study will be presented at the American Society of Oncology conference in Chicago this week.
