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

Veracyte, Inc. (NASDAQ:VCYT), a leading cancer diagnostics company, today announced it has met its targeted enrollment for the NIGHTINGALE trial, which aims to evaluate the clinical utility of its Percepta Nasal Swab test. 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.

"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.⁵

About Veracyte

Veracyte (NASDAQ:VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our 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 our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com or follow us on LinkedIn or X (Twitter).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to our statements related to Veracyte's goal to help clinicians better guide next steps for patients with potentially cancerous lung nodules, that we believe NIGHTINGALE is the largest, most rigorous clinical utility trial for a molecular test focused on patients with lung nodules and that the Percepta Nasal Swab can potentially transform how we manage our eligible patients—and ultimately encourage more patients to get screened for lung cancer. Forward-looking statements can be identified by words such as: "appears," "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will," "enable," "positioned," "offers," "designed," "ultimately," and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to the potential impact the Veracyte Diagnostics Platform can have on scientific advancements in cancer and, in turn, patient care. Additional factors that may impact these forward-looking statements can be found under the caption "Risk Factors" in our Annual Report on Form 10-K filed on February 28, 2025. Copies of these documents, when available, may be found in the Investors section of our website at https://investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the U.S. and selected countries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250826127305/en/

Investors:

Shayla Gorman

[email protected]

619-393-1545



Media:

Tracy Morris

[email protected]

650-380-4413