Clinical Validation Data Published in CHEST Demonstrate that Veracyte’s Percepta Nasal Swab Test Improves Lung Cancer Risk Assessment for Patients with Lung Nodules - Seite 2

For the CHEST study, researchers used the Percepta Nasal Swab test, which was trained on a cohort of 1,120 patients with lung nodules that were either malignant or benign, to evaluate nasal samples from an independent cohort of 312 eligible patients followed for at least 12 months or until a final diagnosis of benign or malignant was determined.

Results show that the Percepta Nasal Swab test is highly accurate in identifying patients with low-risk nodules (97% sensitivity, with 40% specificity). This high sensitivity provides a negative predictive value, or NPV, of 98% in a population with a 25% cancer prevalence, meaning the test could assist physicians in avoiding unnecessary invasive procedures in patients with a benign nodule, with a very small risk of missing a cancer.

Similarly, researchers found that the test is highly accurate in identifying patients with high-risk nodules (92% specificity, with 57% sensitivity). This high specificity provides a positive predictive value, or PPV, of 70% in a population with a 25% cancer prevalence, meaning the test could assist physicians in directing these patients to further procedures so they could obtain an accurate diagnosis and speed time to treatment, if necessary.

The Percepta Nasal Swab test had consistently high performance across various groups of patients within the study cohort, including those with prior cancers and different lung cancer subtypes, lung nodule sizes (including nodules <8 mm), smoking histories and lung cancer screening eligibility, suggesting the test’s potential clinical value in a wide range of patients. In contrast, currently available physician risk calculators were developed with specific patient populations in mind and tend to perform unevenly across different types of patients.

“We believe our Percepta Nasal Swab test can be paradigm-changing in the evaluation of lung cancer risk among patients with lung nodules,” said Dr. Bulman. “By helping to guide next steps for physicians and their patients, we aim to help make lung nodule evaluation, including through lung cancer screening programs, more efficient and effective.”

Publication of the Percepta Nasal Swab test clinical validation study is an important step in Veracyte’s journey toward securing payer reimbursement for the test, prior to the test being made widely available. Additionally, the company is currently conducting a prospective clinical utility study, known as NIGHTINGALE, at hospitals and clinics around the United States to demonstrate the test’s ability to improve patient care and outcomes.