Three-year follow-up trial data successfully demonstrates survival benefit of Oncimmune’s Early-CDT lung cancer diagnostic


Oncimmune Holdings plc (LON:ONC) drew attention to the pre-publication of new research demonstrating how the use of its EarlyCDT-Lung Test, for diagnosing early stage lung cancer, has been shown to reduce mortality when used as part of a cancer screening protocol. The study is based on three-year follow up data from the Early detection of Cancer of the Lung Scotland (“ECLS”) trial. The study validates the commercial value of Early-CDT, which is currently being supplied to the UK NHS, and marketed in the US by Biodesix (with fees payable to Oncimmune). The results will support the continuing sales growth, and accompanying earnings contribution, of the blood based diagnostic test. Our valuation and current forecasts are currently under review pending an update by a new analyst. 

Pre-publication of research paper posted on the medRXiv server

The paper entitled Targeted screening for lung cancer with autoantibodies, will in due course be officially published. The research is based upon a study of 12,208 smokers and ex-smokers, recruited from General Practices in Scotland, aged 50-75 and at risk of developing lung cancer. Patients were tested for lung cancer using EarlyCDT, and if positive subjected to low-does CT scanning every 6-months for up to two years. Patients tested negative using EarlyCDT received standard of care. The study reported results of a three year follow-up.

Patients tested positive using EarlyCDT showed significant survival benefit

After three years, the number of late-stage lung cancer deaths were significantly lower in patients tested with the EarlyCDT Lung blood test. Observable, but non-significant reductions in all cause and lung cancer deaths were also noted.

As perhaps expected, EarlyCDT detected early stage cases of lung cancer in patients initially screened, and did not enable diagnosis as cancers developed later in the follow-up period. The investigators noted that screening programmes of ‘at risk’ individuals should repeat the Early-CDT® test at regular intervals (i.e. multiple tests per patient) to detect newly arising cancers.

Positive research results will likely support ongoing demand for EarlyCDT

Oncimmune’s June 2021 trading statement noted that over Q4 FY2021 additional NHS commercial supply contracts were signed with the NHS for EarlyCDT, with additional NHS supply contacts expected. In addition, sales of the test by US marketing partner Biodesix witnessed a strong recovery in demand, after a COVID-based lull. The recovery in US sales, and increasing use of the test by the UK NHS, is expected to continue throughout FY2022.

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