Veracyte Completes Enrollment in NIGHTINGALE Trial for Percepta Nasal Swab Lung Cancer Test

Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, has announced the successful completion of enrollment in the NIGHTINGALE clinical utility trial for its Percepta Nasal Swab test, a noninvasive molecular diagnostic tool designed to assess lung cancer risk in patients with suspicious lung nodules. The trial has enrolled 2,400 patients across more than 90 academic and community medical centers in the United States, marking a major milestone in the company’s efforts to validate the test’s real-world impact on patient care. The prospective, randomized, blinded study compares outcomes between two groups: patients whose physicians received Percepta Nasal Swab results and those in a control group. Participants will be followed for up to two years to evaluate whether the test reduces unnecessary invasive procedures in patients with low-risk, benign nodules and whether it helps accelerate diagnosis and treatment for those with cancerous nodules. Lung cancer remains the leading cause of cancer-related deaths globally, with an estimated 1.8 million deaths in 2022 according to the World Health Organization, and nearly 125,000 projected deaths in the U.S. by 2025. While annual low-dose CT (LDCT) screening has been shown to reduce mortality, it often detects lung nodules that are not cancerous—leading to anxiety, additional testing, and healthcare costs. The Percepta Nasal Swab test uses a simple nasal brush to collect epithelial cells, which are then analyzed for molecular patterns linked to lung cancer risk. The test leverages whole-transcriptome sequencing and machine learning to generate insights. Clinical validation studies have shown the test has 97% sensitivity for identifying low-risk nodules (with 40% specificity) and 92% specificity for detecting high-risk nodules (with 57% sensitivity). Analytical validation confirmed the test’s accuracy, reliability, and reproducibility across diverse conditions. Dr. Bill Bulman, Veracyte’s Medical Director for Pulmonology, emphasized the importance of clinical utility data: “Demonstrating that a new test can positively impact patient care is key for physician adoption and health insurer coverage.” He described NIGHTINGALE as the largest and most rigorous clinical utility trial ever conducted for a molecular test focused on lung nodules. Dr. Jasleen Pannu of Ohio State University Wexner Medical Center, a participating site, highlighted the test’s potential: “There is a tremendous need for a noninvasive tool that can help physicians better manage patients with lung nodules. If successful, this test could transform patient care and encourage more people to get screened for lung cancer.” Veracyte’s vision is to transform cancer care through high-value diagnostic insights powered by genomic data, advanced bioinformatics, and artificial intelligence. The company continues to build evidence for its tests to support reimbursement, clinical guidelines, and future innovation. Forward-looking statements in this release, including expectations about the test’s impact on patient care and screening rates, are subject to risks and uncertainties. Actual results may differ materially due to factors outlined in Veracyte’s filings with the SEC, including risks related to clinical trial outcomes, regulatory approval, and market adoption.