Veracyte Announces Data Reinforcing the Diagnostic Performance and Utility of the Envisia Genomic Classifier in ILD Diagnosis

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Veracyte, Inc (Nasdaq: VCYT) presented data on the Envisia® Genomic Classifier at the ATS 2021 International Conference. The classifier enhances the diagnosis of interstitial lung diseases (ILDs) by detecting the genomic pattern of usual interstitial pneumonia (UIP). New findings confirm its high specificity (90.6%) and moderate sensitivity (62.5%) in challenging ILD patient subsets. Veracyte plans global availability of the Envisia test on the nCounter Analysis System by year-end 2021, following the acquisition of rights in 2019. This expansion is set to transform patient diagnostics worldwide.

Positive

High specificity (90.6%) and moderate sensitivity (62.5%) of the Envisia classifier, which supports its diagnostic reliability.
Plans to make the Envisia classifier available globally through the nCounter Analysis System by the end of 2021, expanding access for physicians and patients.

Negative

Moderate sensitivity (62.5%) may limit effectiveness in certain patient populations.

05/14/2021 - 04:35 PM

Veracyte, Inc. (Nasdaq: VCYT) announced that data reinforcing the diagnostic performance and utility of the Envisia^® Genomic Classifier are being shared at the American Thoracic Society (ATS) 2021 International Conference, taking place today through May 18. The company is also presenting new data which demonstrate that the novel genomic test can be successfully enabled on the nCounter Analysis System, supporting the company’s plans to make the novel test – for improved diagnosis of interstitial lung diseases (ILDs) – available to physicians and their patients in global markets.

Each year in the United States and Europe, up to 220,000 patients are evaluated for suspected ILDs, including idiopathic pulmonary fibrosis (IPF), which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases. The Envisia Genomic Classifier detects a genomic pattern of usual interstitial pneumonia (UIP) to improve ILD diagnostic and prognostic confidence. The test is performed in Veracyte’s U.S.-based CLIA laboratory. The company plans to be ready to make the Envisia classifier available on the nCounter Analysis System in international markets by the end of this year, which will enable laboratories to perform the test locally.

In one Envisia-related poster presented today, researchers assessed the classifier’s ability to detect UIP among a subset of ILD patients with clinical characteristics that are less commonly associated with IPF (<65 years of age, female, never smokers) and therefore make them especially challenging to diagnose. Researchers retrospectively analyzed 144 samples from ILD patients enrolled in two prior, independent clinical validation cohorts. Findings showed that, across all groups, the Envisia classifier had a 90.6% specificity (CI: 80.7, 96.5) and 62.5% sensitivity (CI: 51.0, 73.1), as compared to histology-proven UIP, and that there were no significant differences when the cohorts were stratified by gender, age and smoking status.

“These findings demonstrate robust performance of the Envisia Genomic Classifier across subsets of patients who are typically less likely to have a UIP pattern or IPF,” said Luca Richeldi, M.D., Ph.D., of Università Cattolica del Sacro Cuore, who presented the data. “This is the first time that study data have been stratified to look at clinical characteristics in this way, and I think physicians will be reassured to learn that the Envisia classifier’s sensitivity and specificity extend to patients who are less likely to have IPF and therefore typically harder to diagnose confidently.”

Additionally, new data presented today suggest that the Envisia classifier may soon be accessible to physicians and patients in global markets via the nCounter Analysis System. Veracyte acquired exclusive global diagnostics rights to the molecular testing platform in December 2019, with plans to facilitate global access to its tests – starting with the Envisia classifier.

Veracyte researchers tested the Envisia classifier’s clinical performance on the nCounter system. They then processed 33 transbronchial biopsy (TBB) samples of varying RNA quality on both an RNA-sequencing platform, which is used in the company’s centralized lab in the U.S., and the nCounter system, using the validated Envisia classifier set of 190 genes. Results show high correlation between the nCounter and RNA-sequencing platforms, suggesting that the classifier’s clinical performance will be maintained on the nCounter system.

“Making our validated genomic tests available on the nCounter system will enable physicians and patients around the world to access timely, critical diagnostic information that can change the path of patients’ disease and lives,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “We are excited to execute on this plan, beginning with the Envisia classifier.”

Multiple abstracts relating to the Envisia Genomic Classifier can be viewed at the links below. The presentations are available on demand to ATS conference registrants through July 2:

Title:

Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status. Abstract #A1839

First Author:

Luca Richeldi, M.D., Ph.D., Università Cattolica del Sacro Cuore, Rome, Italy

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FAQ

What is the Envisia Genomic Classifier's role in diagnosing interstitial lung diseases?

The Envisia Genomic Classifier detects a genomic pattern of usual interstitial pneumonia (UIP), enhancing diagnostic and prognostic confidence in interstitial lung diseases.