A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules
This study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.
• Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
• Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern
• Subject's lung nodule of concern meets the following:
‣ Was incidentally identified or detected during lung cancer screening
⁃ Is a solid nodule
⁃ Has maximal dimension of \> 8mm and \< 30mm
• The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
• The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less