Summary

Summary

  • The technology described in this briefing is EarlyCDT‑Lung. It is a blood test used to classify the malignancy risk of indeterminate pulmonary nodules (IPN) found by chest CT or X‑ray, which would then lead to screening.

  • The innovative aspect is that it can help early diagnosis of lung cancer in people with high risk.

  • The intended place in therapy would be in addition to standard care (CT scans) to detect malignant IPN.

  • The main points from the evidence summarised in this briefing are from 4 studies (1 randomised controlled trial, 2 cohort and 1 case control) involving around 15,000 adults in testing centres in Europe and North America. They show that EarlyCDT‑Lung can detect early stage lung cancer and may improve diagnostic performance. The studies including patients from the UK showed a sensitivity of 52% to 57% and specificity of 88% to 90%. EarlyCDT‑Lung could be more effective than current risk models at identifying lung cancer.

  • Key uncertainties around the evidence or technology are that there is no direct comparative evidence with current standard care and limited follow up with people in the trials.

  • The cost of EarlyCDT‑Lung is £600 per test kit (exclusive of VAT) and each kit can run up to 10 samples, equivalent to £60 per test. The resource impact will be greater than standard care unless the additional cost of the test is offset by any savings from earlier diagnosis. There is limited evidence to support this.