The 2,400-patient study evaluates the Percepta Nasal Swab test’s ability to guide management decisions for patients with lung nodules.
Veracyte Inc has completed targeted enrollment for its NIGHTINGALE clinical utility trial, which aims to evaluate the clinical utility of the company’s Percepta Nasal Swab test for lung cancer screening.
The prospective, randomized, blinded trial enrolled 2,400 patients at more than 90 academic and community centers across the US. Patients were randomized into two groups: those whose Percepta Nasal Swab test results were provided to their physician and a control group. Patients will be followed for up to two years to assess the molecular test’s ability to reduce unnecessary procedures in those with low-risk, benign nodules and to determine whether the test helps accelerate treatment for those with cancerous nodules.
“Demonstrating that a new test can positively impact patient care is key for physician adoption and health insurer coverage,” says Bill Bulman, MD, Veracyte’s medical director for pulmonology, in a release. “We are delighted to complete enrollment for NIGHTINGALE, which we believe is the largest, most rigorous clinical utility trial for a molecular test focused on patients with lung nodules.”
Addressing a Critical Clinical Need
The trial addresses a significant clinical challenge in lung cancer screening. While annual lung cancer screening with low-dose CT is shown to save lives, it also identifies many lung nodules that are not cancerous, which can lead to unnecessary procedures, costs, and patient anxiety.
Lung cancer remains the deadliest cancer worldwide, claiming an estimated 1.8 million lives in 2022, according to the World Health Organization. In the US, the American Cancer Society estimates that nearly 125,000 people will die of lung cancer in 2025.
“There is a tremendous need for a noninvasive tool that can help physicians better care for their patients with lung nodules,” says Jasleen Pannu, MBBS, of Ohio State University Wexner Medical Center, which is participating in the NIGHTINGALE trial, in a release. “We are pleased to be involved with evaluating the Percepta Nasal Swab test, which can potentially encourage more patients to get screened for lung cancer.”
Test Performance Characteristics
The Percepta Nasal Swab test uses a simple brush to acquire nasal epithelial cells for the assessment of molecular changes linked to lung cancer risk in patients with lung nodules and a history of smoking. The test was developed using whole-transcriptome sequencing and machine learning.
Clinical validation study findings showed that the test demonstrates high accuracy when identifying patients with low-risk nodules (97% sensitivity, with 40% specificity). The test also showed high accuracy when identifying patients with high-risk nodules (92% specificity, with 57% sensitivity). An analytical validation study demonstrated the test’s accuracy, reliability, and reproducibility across a range of conditions and variables.
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