Oncimmune Publication in peer reviewed journal validates clinical utility of EarlyCDT Lung

Oncimmune Holdings plc (LON:ONC.L), the leading global immunodiagnostics group, has announced that The European Respiratory Journal – a leading lung disease focused scientific publication and flagship journal of the European Respiratory Society – has published the peer reviewed results from the Early detection of Cancer of the Lung Scotland trial, delivered by the Universities of Dundee and St Andrews with NHS Tayside, and co-funded by Oncimmune, the Scottish Chief Scientist Office and the Scottish Government.

The paper titled ‘Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging’ which is now available online1 and will be replicated in print before Q3 2020, evaluates the effectiveness of Oncimmune’s EarlyCDT Lung test in reducing the incidence of patients presenting with late-stage lung cancer at diagnosis.

To determine whether the EarlyCDT Lung blood test reduced the incidence of patients with stage III/IV lung cancer, the ECLS trial in 12,208 patients compared the use of the EarlyCDT Lung blood test followed by low dose computerised tomography (“CT”) scanning to standard clinical practice. In Scotland, lung cancer affects more than 5,000 people every year of which approximately 4,000 will die of the disease, usually because the diagnosis is made too late for curative treatment.

The ECLS trial is believed to be the largest randomised controlled trial for the detection of cancer using blood-based biomarkers conducted anywhere in the world to date and demonstrated a 36% reduction in late stage diagnoses of lung cancer. In addition, the ECLS trial results indicated a lower rate of both all deaths and lung cancer-related deaths among people in the intervention arm of the trial after two years compared with people in the control group. This suggests that the EarlyCDT Lung test followed by CT imaging could produce a mortality benefit: the 3 year follow up data – scheduled to be analysed imminently – will be critical in substantiating this.

The paper concludes that blood-based biomarker panels, such as the EarlyCDT Lung test, followed by low dose CT, can detect stage I/II lung cancers earlier than standard clinical practice. Earlier diagnosis means that more patients should benefit from newer, more effective, chemotherapy, surgery and radiotherapy, and so reduce the impact of this disease.

Further follow-up analyses on this unique, globally significant cohort will be performed after 5 and 10 years.

Dr Adam M Hill, CEO of Oncimmune, said: “We are delighted to see the ECLS trial data published in the European Respiratory Journal, as it both expands the availability of these results in the wider pulmonology community and confirms through peer review the findings and clinical potential of EarlyCDT Lung. The ECLS trial data was presented on the Presidents podium at WCLC 2019 in Barcelona last year. This publication will unlock discussions with a number of health systems on implementation, many of whom have been looking forward to the validation that this much anticipated peer review brings. We and our partners will now work at speed with health authorities in the UK and further afield to roll out EarlyCDT Lung more widely, ahead of a fuller analysis of the survival benefit of EarlyCDT Lung.”

Professor Frank Sullivan, Professor of Primary Care Medicine at the University of St. Andrews, the Chief Investigator for the ECLS trial, said: “I hope that the results of this trial will have globally significant implications for the early detection of lung cancer by showing how a simple blood test, followed by CT scans, is able to increase the number of patients diagnosed at an earlier stage of the disease, when surgery is still possible and prospects for survival much higher.”

1 https://erj.ersjournals.com/content/early/recent

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