EXPLORE EVIDENCE

Clinical utility
study results

Envisia classifier provides UIP answers with high correlation to expert ILD histopathology results

The CATALYST study evaluated the clinical utility of Envisia classifier as an aid in the diagnosis of IPF compared to histopathology.

Two seperate multidisciplinary teams (MDTs) reviewed randomized cases with clinical information, radiology images, and either histopathology images of Envisia classifier results.

Each MDT determined an IPF or non-IPF diagnosis for each patient. Study results demonstrate 86% agreement between categorical IPF diagnoses using Envisia classifier result compared to diagnoses using histopathology.1

Clinical utility study design: For one case, clinical and central radiology information was sent to two multidisciplinary teams, who either used Envisia classifier results or histopathology results to determine their level of confidence for an IFP or non-IFP diagnosis.
Text: 86% agreement between categorical IPF or non-IPF diagnosis

The impact of the Envisia Genomic Classifier in the diagnosis and management of patients with idiopathic pulmonary fibrosis

In this prospective decision impact survey, the addition of Envisia Genomic Classifier improved IPF diagnostic confidence and appropriate treatment.2

Two 100% stacked bar graphs showing the percentage of patients with different diagnosis with and without the Envisia test: unclassifiable, occupational lung disease, fibrotic HP, idiopathic NSIP, other, and IPF. IPF diagnosis without Envisia is 30% versus 69% with Envisia.

The number of and confidence in IPF diagnoses increased >2X with the addition of Envisia classifier while unclassifiable decreased

p-value <0.001

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