Nasal Swab Test Improves Lung Cancer Risk Assessment for Patients with Lung Nodules

Often, lung nodules, which can be early signs of lung cancer, are detected incidentally during computed tomography (CT) scans conducted for unrelated reasons. Although the majority of these nodules are benign, their discovery can lead to unnecessary diagnostic follow-ups and cause anxiety for patients. Conversely, early identification of malignant nodules can improve patient outcomes significantly. Now, a simple, noninvasive tool can evaluate lung cancer risk in individuals with lung nodules identified on CT scans.

The Percepta Nasal Swab test, developed by Veracyte, is a genomic test that can be easily conducted in a physician's office. The test was developed using RNA whole-transcriptome sequencing combined with machine-learning techniques. It is based on the principle of "field of injury" science, which detects genomic changes linked to lung cancer in the nasal passage's epithelial cells of smokers. The Percepta Nasal Swab test is specifically designed for patients who are current or former smokers and have lung nodules found in CT scans. The test categorizes lung cancer risk into high, moderate, or low levels, aiding physicians in making informed decisions about whether to pursue further lung cancer investigations or to monitor the patient with imaging.

The latest clinical validation data published by Veracyte demonstrates that the Percepta Nasal Swab test accurately identifies lung cancer risk in current or former smokers with lung nodules. This breakthrough genomic test could help doctors guide their clinical decisions, potentially avoiding unnecessary invasive tests or expediting treatment where needed. In the study, researchers used the Percepta Nasal Swab test, initially trained on a group of 1,120 patients with either malignant or benign lung nodules, to analyze nasal samples from an independent group of 312 patients monitored for at least a year or until a definitive diagnosis was reached.

The findings demonstrated that the test accurately identified patients with low-risk nodules (97% sensitivity, 40% specificity), resulting in a 98% negative predictive value in a population with a 25% cancer prevalence. This suggests that the test could help avoid invasive procedures for patients with benign nodules, with minimal risk of missing a cancer diagnosis. Similarly, the test proved highly effective in identifying high-risk nodules (92% specificity, 57% sensitivity), yielding a 70% positive predictive value in a similar population, thereby guiding patients toward further diagnostic procedures and timely treatment.

The Percepta Nasal Swab test showed high performance across various patient groups, including those with previous cancers, different lung cancer subtypes, varying nodule sizes, smoking histories, and lung cancer screening eligibility. This broad applicability highlights the test's potential clinical value across a diverse patient population. In contrast, existing physician risk calculators, which are typically tailored to specific patient groups, tend to have variable performance across different patient types.

“Physicians need an objective, accurate tool to help guide care for patients when a lung nodule is found on a CT scan,” said Bill Bulman, M.D., Veracyte’s medical director for Pulmonology. “Our findings reinforce the ability of the Percepta Nasal Swab test to improve risk assessment of lung nodules and help avoid unnecessary diagnostic procedures for those at low risk of cancer while supporting timely diagnosis and treatment for those with high risk of cancer.”

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