1.1 There is not enough evidence to recommend routine use of EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules.
1.2 Further research is recommended (see section 4) on:
the diagnostic accuracy of EarlyCDT Lung, its performance when used with existing risk models and its effect on clinical management decisions
patient and nodule characteristics that may relate to the prevalence of malignant disease and disease progression
current practice for managing intermediate-risk lung nodules
the clinical consequences of CT surveillance
the likelihood and impact of overtreatment of benign and indolent nodules.
Why the committee made these recommendations
EarlyCDT Lung is used to assess the risk of lung cancer in solid lung nodules. Accurate risk assessment can prevent delayed treatment of malignant nodules or unnecessary biopsies of benign nodules. But, the evidence of how well EarlyCDT Lung works is limited and uncertain.
The company intends for EarlyCDT Lung results to be used to update a person's existing lung cancer risk assessment. But, most studies used EarlyCDT Lung results to classify nodules as benign or malignant. Therefore, most of the existing data does not represent the intended use of the test in updating estimates of lung cancer risk and further validation is needed.
It is also unclear how EarlyCDT Lung will affect lung nodule management in the NHS. This is because there were no studies to show how EarlyCDT Lung affects clinical decision making for people with lung nodules and there is significant variation in management of intermediate-risk nodules in the NHS.
It is also difficult to assess the impact of EarlyCDT Lung on long-term patient outcomes. This is because there is limited data on the factors that might affect disease progression, how lung nodules change during CT surveillance and the likelihood and impact of unnecessary biopsy or surgical removal.
Because of the limited clinical evidence, the cost effectiveness of EarlyCDT Lung was not assessed and so it has not been recommended. Further research is needed on both the EarlyCDT Lung test and on the impact of current lung nodule management. Without more data on current management, it will be difficult to quantify the impact of EarlyCDT Lung and other new tests for assessing lung nodules.