On August 26, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported it has met its targeted enrollment for the NIGHTINGALE trial, which aims to evaluate the clinical utility of its Percepta Nasal Swab test (Press release, Veracyte, AUG 26, 2025, View Source [SID1234655487]). The milestone marks an important step in Veracyte’s goal of making the novel molecular test widely available and helping clinicians to better guide next steps for patients with potentially cancerous lung nodules.
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"Demonstrating that a new test can positively impact patient care is key for physician adoption and health insurer coverage," said Bill Bulman, M.D., Veracyte’s medical director for Pulmonology. "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. We also are deeply appreciative of our many research collaborators and each of the participating patients for their vital contributions to this important study."
The prospective, randomized, blinded NIGHTINGALE trial has now successfully enrolled 2,400 patients at over 90 academic and community centers across the United States. Patients have been randomized to those whose Percepta Nasal Swab test result was provided to their physician, and the 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 assess whether the test helps accelerate treatment for those with cancerous nodules.
Lung cancer is the deadliest cancer worldwide, claiming an estimated 1.8 million lives in 2022, according to the World Health Organization.1 In the U.S., the American Cancer Society estimates that nearly 125,000 people will die of lung cancer in 2025.2 Annual lung cancer screening with low-dose CT (LDCT) is shown to save lives, but it also identifies many lung nodules that are not cancerous3—which can lead to unnecessary procedures, costs and patient anxiety.
"There is a tremendous need for a noninvasive tool that can help physicians better care for their patients with lung nodules," said Dr. Jasleen Pannu, of Ohio State University Wexner Medical Center which is participating in the NIGHTINGALE trial. "We are pleased to be involved with evaluating the Percepta Nasal Swab test, which can potentially transform how we manage our eligible patients—and ultimately encourage more patients to get screened for lung cancer."
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 is highly accurate when it identifies patients with low-risk nodules (97% sensitivity, with 40% specificity). Similarly, the same findings showed that the test is highly accurate when it identifies patients with high-risk nodules (92% specificity, with 57% sensitivity).4 Additionally, an analytical validation study demonstrated the test’s strong accuracy, reliability and reproducibility across a range of conditions and variables.