Pulmonary Nodule Malignancy Risk Assessment


There is a widely acknowledged clinical need for new tools to assess malignancy in indeterminate pulmonary nodules (IPNs)1,2 which are radiographic opacities in the lung that carry some risk of cancer.3

Each year nearly 1.6 million Americans have an incidentally detected nodule on the lung due to the increase in computed tomography (CT) scanning.


1. Massion PP, Walker RC. Indeterminate pulmonary nodules: risk for having or for developing lung cancer? Cancer Prev Res. 2014 7(12): 1173-8.
2. Mazzone PJ, et al. Screening for lung cancer: CHEST Guideline and Expert Panel report. Chest. 2018;153:954-85.
3. Kanne JP, et al. ACR appropriateness Criteria® radiographically detected solitary pulmonary nodule. J Thorac Imaging. 2013;28:W1-3.

The vast majority are benign; EarlyCDT—Lung helps find those that are cancer.



EarlyCDT—Lung is highly specific in detecting lung cancer, making the test complementary to the high sensitivity but poor specificity (i.e., high rate of false-positive results) of CT scanning.

EarlyCDT—Lung is indicated for use in intermediate-risk (10%-65%) nodules. The test’s results, if positive, are combined with the clinician’s initial assessment of risk by current methods to reclassify that risk and accelerate intervention.


EarlyCDT—Lung results may reclassify IPNs to high risk with simple, clinically validated rules:

High Level Result

Consider intervening if your initial assessment of cancer risk in an IPN is 10% or greater and EarlyCDT—Lung is High positive


Moderate Level Result

Consider intervening if your initial assessment of cancer risk in IPN is 45% or greater and the test is Moderate positive.


No Significant Level of Autoantibodies Detected Result

Do not change the pre-test planned clinical management if the test result is No Significant Level of Autoantibodies Detected.

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The test accurately identifies cancers

  • The test enables earlier intervention on nodules initially assessed as lower risk, with low rates of benign resection, to improve patient outcomes.
  • EarlyCDT—Lung test can detect autoantibodies to lung cancer four years or more before diagnosis by standard clinical pathways other than low-dose CT screening.4,5

4 Zhong L, et al. Profiling Tumour-Associated Antibodies for detection of Non-small Cell Lung Cancer. J Thor Oncol 2006; 1:513-519.
5 Jett J, et al. Determination of the detection lead time for autoantibody biomarkers in early stage lung cancer using the UKCTOCS cohort. J Thor Oncol 2017; 12(11):S2170

Clinical Utility

The performance of EarlyCDT-Lung meets all American Thoracic Society criteria for a biomarker test’s clinical readiness for use in indeterminate pulmonary nodules:6

  • Improves on the accuracy of current diagnostic methods
  • The accuracy is sufficient to move the pretest probability of malignancy beyond a clinical decision threshold
  • The balance of benefits and harms strongly favours using the test
  • Calculations can be performed on the relative benefit of a true-positive to false-positive to have clinical benefit. Oncimmune’s simple risk calculator and our clinician support material facilitate these calculations.

Try our calculator

The ACCP guidelines6 recommend assessing the risk of malignancy of a pulmonary nodule with the Swensen/Mayo nodule malignancy risk calculator7 or similar.

Calculate the malignancy risk of a nodule based on the Swensen/Mayo calculator and see how this risk changes with High or Moderate Level test results from EarlyCDT—Lung.

Try our calculator

6 Gould MK, et al. Chest 2013; 143(5):e93S-e120S.
7 Swensen SJ, et al. Arch Intern Med. 1997; 157:849-855.

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