Table 1.

Potential for Harm from an Accurate Biomarker

	Nodule Malignant	Nodule Benign	Total
Test result positive	9	99	108
Test result negative	1	891	892
Total	10	990	1,000

If a molecular biomarker is 90% sensitive and 90% specific for the detection of a malignant lung nodule, it would generally be considered an accurate test. If applied to a population of patients with lung nodules with a 1% probability of malignancy (e.g., solid nodules 4–8 mm in diameter), 92% of all positive test results would be false positive, potentially leading to more aggressive evaluation of many patients without lung cancer, with physical, social, and behavioral consequences.