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A clinical trial of a promising blood test that could offer faster and more accurate diagnoses for common cancers has received funding from the Department of Health and Social Care (DHSC).

The miONCO-Dx test  detects cancer at an early stage by analysing microRNA expression in blood. 

It uses artificial intelligence to identify the presence and origin of the disease. 

The test was developed by Xgenera, a University of Southampton spinout, in collaboration with the National Institute for Health and Care Research.

Initial analysis of data from more than 20,000 patients showed that the test detected 12 of the most common and lethal cancers at an early stage and with over 99% accuracy.

Bowel Cancer Among Key Targets

Bowel cancer, the fourth most common cancer in the United Kingdom, is a principal target for the test. 

Around 44,000 people in the UK are diagnosed with bowel cancer each year. At stage 1, approximately 90% of people survive for 5 years or more, but this drops to around 10% at stage 4. 

Wes Streeting, Secretary of State for Health and Social Care, said in a press release, “The key to surviving cancer is catching it as early as possible, so this government is taking the urgent action needed to make sure that happens.”

£2.4 Million Awarded for Clinical Trial

The DHSC has awarded Xgenera £2.4 million to advance development of the test, which has now been refined into a cheaper, faster, and more scalable version. 

The funding will support a clinical trial involving 8000 patients. The DHSC described this as “a formal and significant step towards bringing the test closer to patients by ensuring it is fit for purpose in the NHS.”

The trial will be run by Cancer Research UK Southampton Clinical Trials Unit.

Potential for NHS Use

Dr Victoria Goss, head of early diagnosis and translational research at the trials unit, said in a press release, “A reliable test such as this could have the potential to see a major shift in cancer screening, making it easier and cheaper to provide on the NHS, cutting health inequalities, and ultimately reducing the number of people who die from the disease.”

Xgenera co-founder Dr Andy Shapanis, a research fellow at the University of Southampton, said that the new study would evaluate the useability, accuracy, and cost-effectiveness of the test for use within the NHS in future. 

“The hope is that if the test is shown to be successful in the early diagnosis of the 12 cancers we have currently identified biomarkers for, then it could be expanded to look at over 50 other cancers in the future,” he said.

Comparison With Other Tests

The miONCO-Dx test follows other attempts at multicancer early detection, such as the Galleri test from Grail, which is already being trialled in the NHS.

Galleri screens for altered DNA methylation patterns in blood and claims to detect more than 50 types of cancer. It raised hopes for earlier diagnosis, less invasive treatment, and potential cost savings.

However, critics have raised concerns about low detection rates in early-stage cancers, high false-positive rates, imprecise cancer origin analysis, cost, and unproven mortality gains. Questions have also been expressed about possible political influence in its selection for NHS trials.

A Broader Screening Platform

Xgenera co-founder Professor Paul Skipp, director of the Centre for Proteomic Research at the University of Southampton, said earlier this year that the miONCO-Dx test was “a real game-changer.” 

The test can detect lung, breast, prostate, pancreatic, colorectal, ovarian, liver, brain, oesophageal, bladder, and gastric cancer and bone and soft-tissue sarcoma. It works by identifying imbalances in microRNAs, a class of small noncoding RNAs with functions in posttranscriptional regulation of gene expression, influencing cellular activities including cell growth, differentiation, development, and apoptosis.

The presence of microRNA imbalances can be identified from just 10-15 drops of blood, across all stages of tumour growth. 

In comparison, according to Skipp, screening is only available currently for three types of cancer in the UK, and each test targets a single type.

Xgenera has also received external investment from the innovation investment companies Qantx, Empirical Ventures, and Ascension Ventures to further develop the test. 

Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.