At the ATS meeting today, investigators presented pivotal clinical validation study results confirming the Envisia classifier's ability to detect usual interstitial pneumonia (UIP), a pattern whose presence is essential to IPF diagnosis, without the need for surgery. The genomic test identified UIP vs. non-UIP with high specificity of nearly 90% and demonstrated sensitivity of 67 percent, meaning it would be expected to identify two thirds of UIP cases with a high degree of accuracy. This performance was compared to a reference standard of histopathology review by a central panel of pathologists with expertise in ILD. The findings are from the 30-site, prospective BRAVE trial and involved 236 transbronchial biopsy (TBB) samples from 49 patients.
"By providing information that today can often only be obtained through surgery, the Envisia classifier has the potential of enabling the diagnosis of IPF," said
Data were also presented from an analytical verification study demonstrating the Envisia classifier's strong accuracy, reproducibility, and robustness in distinguishing UIP from non-UIP under conditions that emulate the operational and biological variation that may be encountered in routine testing. The study included assessing the classifier's ability to determine gene expression in a pooled RNA sample composed of multiple (3-5) TBB samples per patient, with varying mixtures of each sample, illustrating that the test is robust across sampling variations.
"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
About Interstitial Lung Disease
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About the Envisia Genomic Classifier
The Envisia Genomic Classifier is designed to improve physicians' ability to differentiate IPF from other ILDs without the need for surgery. The 190-gene classifier uses machine learning coupled with powerful, deep RNA sequencing to detect the presence or absence of usual interstitial pneumonia, or UIP, a classic diagnostic pattern whose presence is essential for the diagnosis of IPF, using samples obtained through less-invasive bronchoscopy.
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