The independent platform for news, articles and advice for professionals in laboratory medicine

NEWS

Multi-cancer blood test shows real promise in NHS trial

Multi-cancer blood test shows real promise in NHS trial

An NHS trial of a new blood test for more than 50 types of cancer correctly revealed two out of every three cancers in more than 5000 people who had visited their GP with suspected symptoms, in England or Wales. The test also correctly identified the original site of cancer in 85% of those cases.

The SYMPLIFY study is 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 study enrolled 6238 patients, aged 18 and older, in England and Wales 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. Participants provided a blood sample, from which DNA was isolated and tested. The most commonly reported symptoms leading to referral were unexpected weight loss (24.1%), change in bowel habit (22.0%), post-menopausal bleeding (16.0%), rectal bleeding (15.7%), abdominal pain (14.5%), pain (10.6%), difficulty swallowing (8.8%) and anaemia (7.1%).

“Earlier cancer detection and subsequent intervention has the potential to greatly improve patient outcomes,” said Brian D Nicholson, Associate Professor at Oxford’s Nuffield Department of Primary Care Health Sciences, and co-lead investigator of the study.

“Most patients diagnosed with cancer first see a primary care physician for the investigation of symptoms suggestive of cancer, like weight loss, anaemia, or abdominal pain, which can be complex as there are multiple potential causes. 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. 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.”

Within the study, 368 (6.7%) of the 5461 evaluable patients were diagnosed with cancer through standard of care. The most common cancer diagnoses were colorectal (37.2%), lung (22.0%), uterine (8.2%), oesophago-gastric (6.0%) and ovarian (3.8%).

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 with support from National Health Service (NHS) England, NHS Wales, the National Institute for Health and Care Research (NIHR) and NIHR Oxford Biomedical Research Centre.

GRAIL’s MCED test detected a cancer signal in 323 people, 244 in whom cancer was diagnosed, resulting in a positive predictive value (PPV) of 75.5%, negative predictive value (NPV) of 97.6%, and specificity of 98.4%. The overall sensitivity of the MCED test was 66.3%, ranging from 24.2% in stage I cancers to 95.3% in stage IV, and increased with age and later cancer stage. The overall accuracy of the top CSO prediction after a positive MCED test was 85.2%. The mean age of patients in the study was 62.1 years old.

“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,” 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.”

FEATURES

The continued evolution of PCR diagnostics into the community

James Beckett explains how the use of molecular point-of-care testing (POCT) has seen exponential growth in recent years, from its hospital-based origins to its widespread community use for detection of infections, sexual health screening and, more recently, respiratory disease diagnosis during the COVID-19 pandemic.

Improving efficiency in oestradiol testing for rapid IVF support

Testing for oestradiol is a crucial first step in the time-sensitive IVF process. Detailed here are the steps a French-based laboratory was able to take to automate this previously time-consuming and labour-intensive task safely and effectively, while still meeting important deadlines.

The importance of an integrated diagnostic pathway within sepsis care

Current challenges within sepsis diagnostics and AMR show the need for a standardised blood culture pathway. Stefan Schraag explores how the med tech industry can support this through greater education and innovation. This article follows on from a stakeholder event taking a holistic view of the blood culture pathway and encouraging diagnostic integration beyond the walls of laboratories.

Endogenous retroviruses: research published in the recent scientific literature

Relics of ancient viruses, endogenous retroviruses that can be found in human DNA, have recently found exposure in the media. But what range of applications can be found in the recent literature? Here, Pathology in Practice Science Editor Brian Nation compiles a small selection of current research interest in the field.

PRODUCTS

LATEST ISSUEs

June 2023
January 2023
September 2020

Upcoming Events

UKMedLab23

Royal Armouries, Leeds
12-14 June 2023

Liverpool Pathology 2023

University of Liverpool
27-29 June

Microscience Microscopy Congress 2023 (mmc 2023, incorporating EMAG 2023)

Manchester Central Conference Centre
4-6 July 2023

Annual SHOT Symposium 2023

Etihad Stadium, Manchester, M11 3FF
4 July 2023

SHOT webinar: Positive patient identification for safe transfusions in adults

Online
11 July

SHOT webinar: Accurate and complete patient identification for safe transfusions in children

Online
19 July

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

Upcoming Events

UKMedLab23

Royal Armouries, Leeds
12-14 June 2023

Liverpool Pathology 2023

University of Liverpool
27-29 June

Microscience Microscopy Congress 2023 (mmc 2023, incorporating EMAG 2023)

Manchester Central Conference Centre
4-6 July 2023

Annual SHOT Symposium 2023

Etihad Stadium, Manchester, M11 3FF
4 July 2023

SHOT webinar: Positive patient identification for safe transfusions in adults

Online
11 July

SHOT webinar: Accurate and complete patient identification for safe transfusions in children

Online
19 July

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR
Tel: 01892 779999 Fax: 01892 616177
www.step-communications.com
© 2023 Step Communications Ltd. Registered in England. Registration Number 3893025