biostudies-literatureUnknown17(1)Choi Y<h4>Background</h4>Clinical guidelines specify that diagnosis of interstitial pulmonary fibrosis (IPF) requires identification of usual interstitial pneumonia (UIP) pattern. While UIP can be identified by high resolution CT of the chest, the results are often inconclusive, making surgical lung biopsy necessary to reach a definitive diagnosis (Raghu et al., Am J Respir Crit Care Med 183(6):788-824, 2011). The Envisia genomic classifier differentiates UIP from non-UIP pathology in transbronchial biopsies (TBB), potentially allowing patients to avoid an invasive procedure (Brown et al., Am J Respir Crit Care Med 195:A6792, 2017). To ensure patient safety and efficacy, a laboratory developed test (LDT) must meet strict regulatory requirements for accuracy, reproducibility and robustness. The aBMC pulmonary medicine141https://www.ebi.ac.uk/biostudies/studies/S-EPMC5693488biostudies-literatureAnalytical performance of Envisia: a genomic classifier for usual interstitial pneumonia.PMC5693488Cao MImtiaz UHu ZHuang JJiang HTom EYMarchisano CWong MGLu JPankratz DGKennedy GCChoi YHuiras JBarth NMFedorowicz GAnderson JRWalsh PSBabiarz JfalseAnalytical performance of Envisia: a genomic classifier for usual interstitial pneumonia.<h4>Background</h4>Clinical guidelines specify that diagnosis of interstitial pulmonary fibrosis (IPF) requires identification of usual interstitial pneumonia (UIP) pattern. While UIP can be identified by high resolution CT of the chest, the results are often inconclusive, making surgical lung biopsy necessary to reach a definitive diagnosis (Raghu et al., Am J Respir Crit Care Med 183(6):788-824, 2011). The Envisia genomic classifier differentiates UIP from non-UIP pathology in transbronchial biopsies (TBB), potentially allowing patients to avoid an invasive procedure (Brown et al., Am J Respir Crit Care Med 195:A6792, 2017). To ensure patient safety and efficacy, a laboratory developed test (LDT) must meet strict regulatory requirements for accuracy, reproducibility and robustness. The a2017-01-01T00:00:00Z2017 Nov2026-07-09T10:27:51.992Z2026-07-09T10:20:41.357ZS-EPMC56934882914988010.1186/s12890-017-0485-4