Veracyte presented pivotal clinical validation data on the performance of its Envisia Genomic Classifier to diagnose idiopathic pulmonary fibrosis (IPF) at the American Thoracic Society (ATS) 2017 International Conference, held May 19-24 in Washington, D.C.
IPF, a type of interstitial lung disease (ILD), is often challenging to diagnose. Each year, doctors in the United States and Europe evaluate up to 200,000 patients for suspected ILD, including IPF. Physicians typically use high-resolution computed tomography to identify IPF, but this approach often leads to inconclusive results, forcing many patients to undergo invasive and potentially risky surgery for a more definitive diagnosis.
Envisia aims to help physicians differentiate IPF from other ILDs without the need for surgery. The 190-gene classifier uses machine learning technology coupled with deep RNA sequencing to detect the presence or absence of usual interstitial pneumonia (UIP) — a classic diagnostic pattern essential for diagnosing IPF. Envisia works by using samples obtained through a less -invasive procedure called bronchoscopy.
The clinical validation data presented by San Francisco-based Veracyte at ATS 2017 confirmed Envisia’s ability to detect UIP. The genomic test identified UIP versus non-UIP with high specificity (nearly 90 percent) and demonstrated sensitivity of 67 percent, meaning it would be expected to identify two-thirds of UIP cases. A panel of pathologists who are experts in ILDs compared Envisia to a reference standard of histopathology review. Data in the presentation came from the prospective BRAVE study, which involved 236 transbronchial biopsy (TBB) samples from 49 participants.
“By providing information that today can often only be obtained through surgery, the Envisia classifier has the potential of enabling the diagnosis of IPF,” senior author of the study, Dr. Ganesh Raghu, said in a press release. “This new molecular approach to diagnosis of IPF will hopefully serve the patients better in ascertaining the diagnosis of IPF.”
Veracyte’s presentations about Envisia at ATS 2017 included:
- “Cohort Comparison Between Transbronchial Cryobiopsy and Surgical Lung Biopsy (SLB) in Patients Undergoing a Workup for Interstitial Lung Disease (ILD) from a Multicenter, Prospective Trial”
- “A Concordant Usual Interstitial (UIP) Diagnosis from Surgical Lung Biopsies (SLBs) Remains a Challenge for Patients with Interstitial Lung Disease (ILD)”
- “Prospective Validation of a Molecular Test for Usual Interstitial Pneumonia in Transbronchial Biopsies”
- “Analytical Performance of Envisia: a Genomic Classifier for Usual Interstitial Pneumonia Pattern”
“The data presented today demonstrate the significant role that the Envisia Genomic Classifier can play in resolving uncertainty in IPF diagnosis so that patients can get the answers they need without undergoing surgery,” said Veracyte Chairman and CEO Bonnie Anderson. “These data also represent remarkable progress as we build the library of clinical evidence to support physician adoption and payer reimbursement for the test.”