Veracyte has announced the launch of its non-invasive test to improve the diagnosis of interstitial lung diseases, including idiopathic pulmonary fibrosis (IPF). The soon-to-be commercially available test, Envisia Genomic Classifier, is reported to offer a faster and more accurate diagnosis than is currently available without the need for a lung biopsy.
Data supporting the clinical validity of Envisia was shown at a private event for pulmonologists and other respiratory specialists at the recent American College of Chest Physicians (CHEST 2016) annual meeting, held in Los Angeles.
Envisia uses machine learning together with deep RNA sequencing to detect the presence or absence of usual interstitial pneumonia (UIP), a classic diagnostic pattern “essential” to detecting IPF, the company said in a press release. Physicians now use high-resolution CT imaging (HRCT) to identify UIP in people suspected of having IPF, a difficult to diagnose disease, but CT results can be inconclusive and a surgical histopathology is also often required.
“The availability of a clinically validated genomic classifier for patients with suspected IPF will be a significant step forward in ensuring an accurate and timely diagnosis,” Ganesh Raghu, MD, professor of medicine in the Division of Pulmonary and Critical Care Medicine and director of the Center for ILD at the University of Washington, said in a press release. “In the current diagnostic pathway, an accurate diagnosis may require a surgical lung biopsy to confirm the presence of UIP. This is an invasive, costly and potentially risky procedure.”
At the CHEST event, Veracyte’s chief scientific officer, Giulia C. Kennedy, PhD, presented data from the prospective BRAVE study, in which company scientists first trained the Envisia classifier — using 350 tissue samples obtained from 90 IPF patients through an outpatient bronchoscopy — to differentiate UIP from non-UIP.
The researchers than assessed the clinical validity of the locked 190-gene classifier using an independent set of samples from 49 study participants.
Results found that Envisia was capable of distinguishing UIP from non-UIP samples with high specificity (88%) and a sensitivity of 67%, meaning it would be expected to identify nearly two-thirds of UIP cases.
“Patients with suspected ILD [interstitial lung disease], including IPF, endure a significant delay in diagnosis, frequent misdiagnosis and often require invasive procedures to get definitive answers,” said Gregory Cosgrove, MD, an associate professor of medicine at National Jewish Health, and CEO of the Pulmonary Fibrosis Foundation. “Better tools are needed to reduce the clinical impact, anxiety and cost involved in an IPF diagnosis. Based on the clinical validity data … the Envisia classifier could help to fill this compelling, unmet need.”
Veracyte plans to make Envisia available to physicians at a limited number of U.S. institutions starting in December, aiming to build the clinical evidence necessary to support Medicare reimbursement for the test’s use, the same approach it used for its genomic classifier tests for lung cancer and thyroid cancer.