Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.
Is able to give signed informed consent and comply with study requirements.
≥50 - 80 years of age.
current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years.
Has a >6 to <30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan.
Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
The dominant nodule is ground glass or part solid as determined by CT scan.
Has 5 or more nodules sized >4 mm.
The nodule sized >6 to <30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
bioAffinity Technologies Inc.
Lead sponsor