Veracyte Announces New Pivotal Clinical Validation Data at ASCO Showing Noninvasive Nasal Swab Test Can Significantly Improve Early Lung Cancer Detection

Veracyte, Inc. (Nasdaq: VCYT) today announced pivotal clinical validation data showing that the company’s noninvasive nasal swab test can significantly improve the early assessment of lung cancer. The new findings show that the Percepta Nasal Swab, a first-of-its-kind genomic test, accurately classifies lung cancer risk in current or former smokers with lung nodules so that those with benign nodules may safely avoid unnecessary additional procedures, while those with likely cancerous nodules may receive more timely diagnosis and treatment. The findings will be presented June 4, 2021 at the American Society of Clinical Oncology (ASCO) Annual Meeting.

“Lung nodules are often the first sign of lung cancer and cannot be ignored, yet most of them are benign,” said Carla R. Lamb, M.D., interventional pulmonologist at Lahey Hospital & Medical Center in Burlington, Mass., who was an investigator on the nasal classifier study. “Today, physicians have limited objective tools to determine which patients with lung nodules found on CT scans have cancer and which don’t. Our findings showed that the nasal swab test can determine, with a high level of accuracy, which patients are at low risk of cancer and can avoid invasive procedures. Similarly, it can identify which patients are at high risk and may be confidently directed to further work-up and, potentially, to the treatment they need. An objective tool that can accurately inform these decisions could be a game-changer for early lung cancer assessment.”

For the study, researchers evaluated the performance of the nasal swab test on a blinded, independent validation set of 249 patients from multiple cohorts of prospectively collected nasal samples of current or former smokers undergoing evaluation for lung nodules found on computed tomography (CT). All were followed for up to one year or until physicians made a final, adjudicated diagnosis. The cancer prevalence in the validation cohort was 54% -- higher than the 25% cancer prevalence expected in the broad population of patients with suspicious nodules, on which the test is expected to be used.

Results of the validation study demonstrate that the test identifies patients as low risk for cancer with a sensitivity of 96.3% (CI: 91.6%-98.4%) and specificity of 41.7% (CI: 33.1%-50.9%). At the same time, the test identifies patients as high risk for cancer with a specificity of 90.4% (CI: 83.68%-94.57%) and sensitivity of 58.2% (CI: 49.74%-66.22%). These findings show the test classifies more than 40% of patients with confirmed benign nodules as low risk, allowing them to avoid further procedures, and it classifies nearly 60% with confirmed malignant nodules as high risk, enabling them to be directed to more timely diagnosis and potential treatment. The remaining patients were classified as intermediate risk for cancer.