Veracyte Studies at CHEST Demonstrate Envisia’s Ability to Aid in Diagnosis of Interstitial Lung Disease
Veracyte, Inc. (Nasdaq: VCYT) has unveiled new data at the American College of Chest Physicians (CHEST) Annual Meeting 2023, highlighting the clinical utility of its Envisia Genomic Classifier. This classifier aids physicians in enhancing diagnostic and prognostic confidence in patients with interstitial lung diseases (ILDs) and addresses the challenges of identifying usual interstitial pneumonia (UIP). The Envisia test leverages the capabilities of RNA sequencing and machine learning to generate a genomic pattern for Usual Interstitial Pneumonia (UIP). This pattern plays a crucial role in diagnosing idiopathic pulmonary fibrosis (IPF) and is linked to a grim prognosis in various ILD subtypes.
Each year in the United States and Europe, about 200,000 patients are suspected of having interstitial lung diseases (ILDs), with idiopathic pulmonary fibrosis (IPF) being one of the most common and deadliest forms. IPF is challenging to diagnose, leading to treatment delays, misdiagnoses, patient distress, and increased healthcare costs. A timely IPF diagnosis is crucial, given the availability of anti-fibrotic treatments that can slow disease progression. Current technologies, like high-resolution computed tomography (HRCT), often fail to differentiate IPF from other ILDs, resulting in inconclusive results and invasive diagnostic procedures.
Veracyte presented two independent studies showing the potential of Envisia to aid in the diagnosis of ILDs. The first study conducted at UCLA Health, researchers reviewed electronic medical records for 83 patients to assess the impact of adding the Envisia Genomic Classifier to transbronchial lung cryobiopsy (TBLC) testing on UIP diagnostic yield. TBLC alone resulted in a clear diagnosis for only 46% of patients, which was even lower for those with indeterminate HRCT results (23%). However, combining the cryobiopsy procedure with the genomic classifier improved the diagnostic yield in both cases, reaching a diagnosis in 61% of cases. For patients with indeterminate HRCT results, the Envisia Genomic Classifier more than doubled the UIP diagnostic yield to 49%.
Dr. Augustine Chung, pulmonary director of the Connective Tissue Disease-Interstitial Lung Disease Clinic at UCLA Health, stated, “We found that incorporating Envisia testing significantly increased the diagnostic yield of cryobiopsy for ILD in our overall cohort, as well as in the patients with indeterminate results on high-resolution CT. A higher diagnostic yield could help physicians recommend the most appropriate treatment for their patients with ILD.”
The second study focused on the subjectivity of results obtained from HRCT scans in patients with suspected ILD. Two expert thoracic radiologists independently reviewed tomography scans for 74 ILD cases, using criteria recommended by current guidelines to identify UIP. The analysis revealed that concordant results were found in just 61% of cases. These findings suggest that CT results may be less reliable when used without a complementary test like the Envisia Genomic Classifier, particularly in cases that do not meet criteria for “typical” UIP, where concordance was only 50% for “Probable UIP” and 0% for “Indeterminate for UIP.”
Dr. Bill Bulman, Veracyte’s medical director for Pulmonology, commented, “Collectively, these studies underscore the clinical value of the Envisia Genomic Classifier test for helping physicians determine whether UIP is present in patients with ILD. They also support the clinical utility of using the Envisia test as a complement to current diagnostic procedures to improve ILD diagnostic and prognostic confidence.”