New Clinical Utility Data Confirm Veracyte’s Envisia Genomic Classifier Increases Accuracy and Confidence in IPF Diagnosis

Findings to be shared in oral presentation at CHEST Annual Meeting 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced new data demonstrating that the Envisia Genomic Classifier positively impacts clinical decision-making in idiopathic pulmonary fibrosis (IPF) by increasing diagnostic accuracy, physician confidence in diagnosis, and patient referral to appropriate therapy. The data, from a prospective, randomized decision-impact survey involving more than 100 pulmonologists, will be shared October 18 in an oral presentation at the American College of Chest Physicians (CHEST) Annual Meeting 2021 (Abstract #40063).

Veracyte estimates that each year in the United States and Europe approximately 200,000 patients have unclear results following evaluation for suspected interstitial lung diseases (ILDs), including IPF, which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases. The Envisia Genomic Classifier is a highly accurate, clinically validated molecular test that detects a genomic pattern of usual interstitial pneumonia (UIP), a critical factor that can help physicians differentiate IPF from other ILDs.

“Physicians and patients need more objective, accurate tools to diagnose ILD and IPF so that patients can receive appropriate treatment and avoid further, invasive procedures such as surgical lung biopsy,” said Marc Stapley, Veracyte’s chief executive officer. “The new data being presented at CHEST next week suggest that the Envisia classifier can help address this long-standing clinical gap, enabling physicians and patients to make better, faster and more confident care decisions.”

Researchers led by Joseph Lasky, M.D., of Tulane University Medical School surveyed 103 practicing pulmonologists to determine the impact of the Envisia classifier on clinical decision-making in IPF. Each survey participant received five patient cases from the BRAVE (Bronchial Sample Collection for a Novel Genomic Test) study and was asked to determine an ILD diagnosis, their confidence level in their diagnosis and the next management step. A cohort of 81 physicians initially reviewed cases without Envisia test results (pre-Envisia) and then again with the classifier results added (post-Envisia). Researchers randomly selected the patient cases from a set of 11 that all had undiagnosed ILD, a high-resolution computed tomography (HRCT) scan without a “typical” UIP pattern, and a UIP-positive Envisia test result, and had undergone multidisciplinary team discussion that resulted in a final diagnosis of IPF.

Results show that the Envisia classifier significantly increases IPF diagnosis, physicians’ confidence in their diagnosis and recommendations for patients to initiate treatment. Among the cohort of 81 physicians who reviewed cases both pre- and post-Envisia (a total of 155 case reviews):

• IPF diagnosis increased by 39% from 47 (30%) pre-Envisia to 107 (69%) post-Envisia (Odds Ratio [OR]:16.43; Confidence Interval [CI]=7.52,41.96; p

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