Veracyte announces preliminary nasal swab test clinical data
Veracyte announced preliminary clinical data showing that the company's noninvasive nasal swab test can enable early lung cancer detection and diagnosis. The new findings specifically show that the novel genomic test can accurately classify lung cancer risk in patients with lung nodules so that these patients can obtain the prompt diagnosis and potential treatment they need or may be monitored noninvasively. The findings will be presented at the annual meeting of the American College of Chest Physicians. To develop and evaluate the test, Veracyte utilized nasal samples from over 700 patients with lung nodules found on computed tomography, or CT, scans who were prospectively recruited and whose cancer status was subsequently determined. The researchers evaluated the test's performance on an independent blinded subset of 261 patients. The researchers determined the genomic test's ability to identify patients as high risk and low risk for cancer and then modeled its impact on patient care when the cancer prevalence is 25%. This aligns with the anticipated cancer prevalence among the people on whom the test will eventually be used. Among patients whose nodules were benign, the genomic test classified over 40% as low risk for cancer, with a sensitivity of over 95%, meaning that these patients could be monitored noninvasively with a low chance of missing a cancer. Among patients whose nodules were malignant, the test classified over 40% as high risk for cancer, with a specificity of over 94%, meaning these patients could be directed to more invasive diagnostic procedures and treatment, with a low rate of false positive results. The test's performance was consistent regardless of lung nodule size or location, as well as cancer subtype or stage. Currently, physicians use clinical factors to calculate the risk of cancer when a lung nodule is found. However, these calculators vary widely in how they measure risk, produce differing results and have in some cases been shown to be less accurate than physician judgment alone. Researchers in the current study determined that the nasal swab test would identify over 70% more patients as "low risk" and 18% more patients as "high risk," as compared to one of the most widely used clinical risk calculators.