The growth of CT screening for lung cancer is leading to a significant increase in the number of patients diagnosed with nodules in the lungs (more than 1.5m patients with pulmonary nodules expected per annum in the US1).

But CT screening has a high false positive rate – over 96% of these nodules found in the NLST study were benigni – a major concern for pulmonologists.

The EarlyCDT®-Lung test has the potential to enhance significantly current risk assessment protocols recommended in guidelines in the US2.

  • EarlyCDT-Lung blood test significantly aids the risk assessment of intermediate risk (10% to 65%) pulmonary nodules (8-20mm)
  • A ‘High’ EarlyCDT-Lung test result has high specificity (98%) and PPV > 80% and so is complementary to the high sensitivity of CT screening for ‘ruling-in’ lung cancer
  • A ‘High’ result shifts all patients from intermediate risk to intervention risk
  • EarlyCDT-Lung reduces the number of patients in the ‘watch and wait’ category and aids early lung cancer detection. PPV > 80% so 4 out of 5 results are a true cancer

EarlyCDT-lung test results

The EarlyCDT-Lung test results can shift the nodule risk calculated with the Swensen/Mayo model3.

  • Data published in the Journal of Thoracic Oncology4 from Vanderbilt University showed that a positive EarlyCDT®-Lung test indicates that a nodule is two to three times more likely to be cancer.
  • For intermediate (10% to 65%) risk nodules, a ‘High’ test result shifts the patient’s risk to “intervention” risk i.e. > 65%
  • A ‘Moderate’ test result adds 25% to the patient’s calculated risk
  • A ‘No Significant Level of Autoantibodies Detected’ result does not change the patient’s risk, it does not rule out lung cancer now or in the future


1 Sethi S, Parrish S. Journal of Thoracic Disease. 2016;8(Suppl 6):S494-S497

2 Gould MK, Donington J, Lynch WR, et al. Evaluation of individuals with pulmonary nodules: when is it lung cancer? diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5)(suppl): e93S-e120S.

Swensen SJ, et al. Arch Intern Med. 1997; 157:849–855.

4 Autoantibody Signature Enhances the Positive Predictive Power of Computed Tomography and Nodule-Based Risk Models for Detection of Lung Cancer. Massion PP, Healey GF, Peek LJ, et al. J Thorac Oncol. 2017; 12(3):578-584.


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