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US-based healthcare company GRAIL and the University of Oxford, UK, have announced encouraging first prospective study results at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023 for their multi-cancer early detection (MCED) test for patients who were referred for diagnostic follow-up for suspicion of cancer.

SYMPLIFY is the first large-scale evaluation of an MCED, enrolling 6,238 patients aged 18 or older in England and Wales who were referred for urgent imaging, endoscopy or other diagnostic tests to investigate potential gynaecological, lung, lower or upper gastrointestinal tract (GI), or non-specific cancer symptoms. The most commonly reported symptoms included: unexpected weight loss (24.1%); change in bowel habit (22%); post-menopausal bleeding (16%); rectal bleeding (15.7%); abdominal pain (14.5%); pain (10.6%); difficulty swallowing (8.8%); and anaemia (7.1%).

The MCED test’s predictions were compared with diagnoses obtained from traditional methods or investigated. It detected a cancer signal in 323 people, of which a cancer diagnosis was made in 244 ‒ apositive predictive value (PPV) of 75.5%, negative predictive value (NPV) of 97.6%, and a specificity of 98.4%. The overall sensitivity was 66.3%, with a range from 24.2% in stage I cancers to 95.3% in stage IV, that also increased with age.

Sir Harpal Kumar, president of GRAIL Europe, stated: “GRAIL’s earlier PATHFINDER study previously 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.”