Analytical performance of a bronchial genomic classifier.

Area of Science:

• Pulmonary Medicine
• Genomic Diagnostics
• Molecular Pathology

Background:

• Lung lesion diagnosis often yields inconclusive results, necessitating invasive follow-up procedures due to a high rate of benign lesions.
• The Percepta bronchial genomic classifier was developed to improve lung nodule and lesion classification from bronchoscopy specimens.
• Existing diagnostic methods for lung lesions can be invasive and lead to unnecessary procedures.

Purpose of the Study:

• To report the analytical performance of the Percepta bronchial genomic classifier.
• To evaluate the stability, sensitivity, specificity, and reproducibility of the Percepta test.

Main Methods:

• Analyzed RNA stability in bronchial brushing specimens under various conditions.
• Determined analytical sensitivity based on RNA input mass.
• Assessed analytical specificity by testing for interference from blood and genomic DNA.
• Evaluated assay reproducibility across different operators, runs, reagent lots, and laboratories.

Main Results:

• RNA in specimens is stable for up to 20 days at 4°C.
• The assay is tolerant to variations in RNA input (157-243 ng).
• No interference was observed from blood or genomic DNA up to 10% input mass.
• High reproducibility was confirmed, with a standard deviation of 0.26 for scores on a >6 unit scale.

Conclusions:

• The Percepta test demonstrated strong analytical sensitivity and specificity.
• The robustness and reproducibility of the Percepta test were verified.
• These findings support the clinical utility of the Percepta bronchial genomic classifier for lung lesion diagnosis.