Veracyte, Inc., presented new data indicating that its in-development genomic test, the Envisia classifier, has the potential to diagnosis idiopathic pulmonary fibrosis (IPF), distinguishing it from other interstitial lung diseases (ILD), and reduce the need for invasive diagnostic surgeries. The findings were presented by Dr. Giulia C. Kennedy, the company’s chief scientific officer, at the recent American Thoracic Society (ATS) 2016 International Conference in San Francisco, California.
Findings presented suggest the Envisia classifier is accurate in identifying IPF in patients, a notoriously difficult to diagnose condition, and is a better diagnostic tool than high-resolution CT (HRCT) imaging alone.
Researchers obtained 211 samples from 59 patients, through less-invasive transbronchial biopsy (TBB), and developed a prototype genomic classifier. This system uses deep RNA sequencing to determine the presence of usual interstitial pneumonia (UIP) in patient samples, a pathology marker that is essential for an IPF diagnosis.
The team then tested the system’s efficiency on 35 patients, who each contributed up to five TBB samples. Results indicated that the prototype classifier correctly identified, with 93% sensitivity and 58% specificity, the majority of samples as UIP from the 20 patients with a UIP pattern confirmed by pathology. In contrast, HRCT imaging only confirmed 5 out of the 19 patients (26%) with a UIP histopathologic pattern.
“Physicians traditionally use HRCT imaging to diagnose IPF, but results can be ambiguous and surgical lung biopsy (SLB) is often needed to obtain a more definitive diagnosis,” Dr. Kennedy said in a press release. “These findings are significant because they suggest that the Envisia classifier may potentially help improve IPF diagnosis and reduce the need for surgery in patients with suspected ILD. This is particularly important because these patients are often too frail to undergo such an invasive procedure.”
Another study, also presented at the conference, highlighted the need for a reliable genomic test for clinical decision-making in IPF diagnosis, particularly in community settings. In the study, local pathologists failed to identify more than one-third (34%) of IPF cases among 56 patients with suspected ILD. A third presentation, by researchers at Weill Cornell Medical College and the University of Michigan, came from a survey indicating physician support for the potential ability of Veracyte’s genomic classifier to reduce the need for invasive diagnostic procedures, leading to more appropriate and timely treatment of IPF patients.
“We believe that the Envisia classifier will help transform care among the hundreds of thousands of patients who present each year with a suspected ILD,” said Bonnie Anderson, president and chief executive officer of Veracyte. “A growing body of data suggests that Envisia has the potential to both reduce the time required for patients to receive an accurate diagnosis and to reduce the number of patients who must undergo risky, invasive surgeries to obtain such a diagnosis.”
Veracyte expects to launch the Envisia classifier in late 2016.