The first noninvasive nasal swab test for lung cancer enables early detection and diagnosis, according to preliminary clinical data presented at Chest 2019 by Veracyte Inc.
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.
To develop and evaluate the test, Veracyte utilized nasal samples from over 700 patients with lung nodules found on computed tomography (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 very 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 percent more patients as “low risk” and 18 percent more patients as “high risk,” as compared to one of the most widely used clinical risk calculators.
“Early lung cancer detection is key to saving lives. However, today when a potentially malignant lung nodule is found, physicians lack accurate and reliable tools to determine which patients require more invasive diagnostic evaluation and those who can be managed with noninvasive surveillance,” said Carla R. Lamb, M.D., interventional pulmonologist at Lahey Hospital & Medical Center, in Burlington, Mass., who was a primary investigator on the nasal classifier study and will present the findings. “Given the nasal classifier’s ability to more accurately classify cancer risk in patients with lung nodules, the test can help address this diagnostic gap, potentially helping to save more lives while also enabling patients to avoid unnecessary invasive procedures and reducing costs.”
Veracyte is collaborating with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson have combined clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte has contributed bronchial and nasal samples from its clinical trials, which are part of the company’s extensive lung cancer-focused biorepository.
“Lung cancer is the leading cancer killer worldwide,” said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. “We are very encouraged by these preliminary data, which suggest that our nasal swab test has the potential to transform how this disease is diagnosed, enabling lung cancer patients to get the treatment they need sooner, while helping patients with benign nodules avoid unnecessary and costly invasive procedures. These data also mark the latest milestone in our long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson.* We look forward to finalizing and making our test available to physicians and their patients by early 2021.”