miONCO-Dx : A novel multi cancer early diagnostic test

Cancer is a leading cause of death worldwide accounting for nearly 10 million deaths in 2020. In the UK alone, there are approximately 367,000 new cancer cases every year (CRUK).

It is well established that much of the morbidity and mortality in human cancer is related to late diagnosis, where radical therapies are less effective.

Late-stage diagnoses often leading to survival rates below 10% but identifying cancer early can increase survival rates to over 90% and reduce treatment costs by threefold (CRUK). Globally, healthcare systems are prioritising early diagnosis.

In the UK, the NHS has set ambitious goal of increasing survival rates for 55,000 people annually and diagnosing 3 out of 4 cancers at an early stage by 2028.

Currently, there are only four national cancer screening programmes in England for cervical, breast, bowel and more recently lung cancer.

These are performed individually using imaging tests, histopathological analysis of biopsied tissue but suffer from poor specificity.

Multi-cancer early detection (MCED) testing with a very low false positive rate across all cancer stages from a single blood draw would lead to a paradigm shift in cancer-screening resulting in major public health impact through both improved clinical decision making and patient survival outcome.      Xgenera has developed an innovative MCED test called miONCO, which can detect 12 of the most lethal cancers at even the earliest stages from only 100 mL of blood serum.

Developed and tested using microRNA data from 20,000 patients, miONCO-Dx shows superior performance to all other competing solutions achieving a >99% sensitivity and specificity for a cancer/no-cancer prediction for all 12 of these cancers, and at all stages (I-IV). Importantly, miONCO-DX can predict the tumour site of origin with an accuracy of 98%.

In a partnership between Xgenera, University of Southampton and University Southampton Hospital, the primary objective of this project is to advance the technology Readiness Level of miONCO-Dx from 4 to 7 ready for UKCA conformity assessment as an in vitro diagnostic.

This will be delivered through two integrated work packages (WP) for optimising efficiency and throughput (WP1) and evaluating the technical and clinical performance of miONCO-Dx using samples obtained from several retrospective pre-diagnosis/asymptomatic cohorts (WP2). This project will deliver a validated MCED for early detection of 12 of the most lethal and prevalent cancers.

Given the current sensitivity and specificity performance of miONCO-Dx, implementation of this MCED could save tens of thousands of lives each year through identifying cancer earlier, leading to more effective and less aggressive treatment, resulting in healthier and longer life for individuals.

Identifying cancer earlier will also reduce the cost to healthcare providers, not only because treatment at an early stage is cheaper, but because miONCO-Dx will offer a cost effective solution in comparison to other MCEDs.

This cost-effective and non-invasive blood-based test will deliver early diagnosis across a broad populations including those in socially deprived and remote areas. These impacts will be realised by commercialisaton of miONCO-Dx through Xgenera.