The diagnosis of idiopathic pulmonary fibrosis (IPF) is still difficult, leading to misdiagnosis or delayed treatment. In the absence of an identified etiology, IPF is diagnosed by the presence of a radiographic or histologic usual interstitial pneumonia (UIP) pattern. The Envisia Genomic Classifier is a molecular diagnostic tool that detects UIP in transbronchial biopsies and has been clinically validated. To see how the Envisia Genomic Classifier affects physicians’ clinical decision-making regarding the diagnosis and treatment of IPF. They created this prospective randomized decision impact study to see if including an Envisia UIP positive (UIP+) result will boost IPF diagnoses, diagnostic confidence, and antifibrotic medication recommendations. Patients from the BRAVE study who had an HRCT scan with no characteristic UIP pattern, Envisia UIP+ result, and a final diagnosis of IPF based on a multidisciplinary team discussion were included in the survey. Each case had three distinct ways: a pre-post cohort in which each instance was presented without Envisia first, then with Envisia, and two independent cohorts. Each patient was given without and with Envisia separately.
Pulmonologists from the community and academic facilities around the United States were approached for participation in this study. 605 case reviews of 11 patient cases were supplied by 103 (65%) US-based pulmonologists who matched the inclusion criteria. In the pre-post cohort, the number of IPF diagnoses increased by 39%, from 47 (30%) pre-Envisia to 107 (69%) post-Envisia, and by 13% in the independent cohorts. Envisia was more usually associated with high confidence (> 90%) ILD diagnosis in the pre-post and independent cohorts. Recommendation for antifibrotic treatment increased by 36% with Envisia, from 15% pre-Envisia to 72% (46.4%) post-Envisia in the pre-post cohort and 11% in the pre-post cohort independent cohorts. This decision impact survey demonstrates the clinical utility of the Envisia Classifier by showing a significant increase in IPF diagnoses, diagnostic confidence, and antifibrotic therapy recommendations, all of which can help physicians better manage patients with IPF improve their outcomes.