Veracyte Completes NIGHTINGALE Study Enrollment

Veracyte Inc. has met its targeted enrollment for the NIGHTINGALE trial, which aims to evaluate the clinical utility of its Percepta Nasal Swab test. The company is determined to make the molecular test widely available to help clinicians better gauge the next steps for patients with potentially cancerous lung nodules.

“Demonstrating that a new test can positively impact patient care is key for physician adoption and health insurer coverage,” Veracyte Pulmonology Medical Director Bill Bulman, M.D., said. “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 contributions to this study.”

The prospective, randomized, blinded NIGHTINGALE trial has enrolled 2,400 patients at more than 90 U.S. academic and community centers. 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 United States, 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 computed tomography (LDCT) can 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 to assess 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 the test is highly accurate when it identifies patients with low-risk nodules (97% sensitivity, with 40% specificity). Similarly, the same findings showed 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.⁵

Veracyte is a global diagnostics company striving to transform cancer care. Its Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for the tests, along with new insights to support continued innovation and pipeline development.

References
¹ World Health Organization. Global cancer burden growing, amidst mounting need for services. WHO. Published February 1, 2024. Accessed July 24, 2025. https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services
² American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025.
³ Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409.
⁴ Lamb CR, Rieger-Christ KM, Reddy C, et al. A nasal swab classifier to evaluate the probability of lung cancer in patients with pulmonary nodules. CHEST. 2024;165(4):1009-1019.
⁵ Wu S, Jiang R, Fedorowicz G, et al. Analytical validation of the Percepta Nasal Swab classifier; an RNA next-generation sequencing assay for the assessment of lung cancer risk in pulmonary nodules. BMC Cancer. Published March 31, 2025;25:577.