Envisia evidence library

In 96 patients with suspected ILD the Envisia Genomic Classifier identified UIP regardless of HRCT pattern. These results suggest that recognition of a UIP pattern by Envisia combined with HRCT and clinical factors in a multidisciplinary discussion may assist clinicians in making an interstitial lung disease (especially IPF) diagnosis without the need for a surgical lung biopsy.

Envisia identified usual interstitial pneumonia in transbronchial lung biopsy samples from 49 patients with 88% specificity and 70% sensitivity.

The clinical utility data confirms the use of the Envisia Classifier to increase physician confidence in diagnosis of IPF, and recommendation for antifibrotic therapy, while also reducing invasive and potentially risky surgical lung biopsies (SLBs).

The Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status

Envisia Genomic Classifier enables physicians to more confidently diagnose idiopathic pulmonary fibrosis (IPF), when results from high-resolution CT (HRCT) imaging are not definitive.

Authors demonstrated proof of principle that genomic analysis and machine learning with Envisia improves the utility of TBB for the diagnosis of UIP, with greater sensitivity and specificity than pathology in TBB alone.

Results show that the development of a genomic signature that predicts usual interstitial pneumonia is feasible. These findings are an important first step towards the development of a molecular test that could be applied to bronchoscopy samples, thus avoiding surgery in the diagnosis of idiopathic pulmonary fibrosis.

The authors demonstrated that the suggested methodologies appropriately addressed challenges of the sample size, disease heterogeneity and technical batch effects and developed a highly accurate and robust classifier leveraging RNA sequencing for the classification of UIP.

The Envisia test demonstrates the robust analytical performance required of an LDT. Envisia can be used to inform the diagnoses of patients with suspected IPF.

There is high agreement between multidisciplinary IPF/non-IPF diagnoses which incorporate Envisia test results versus those based on histopathology. Envisia may enhance physician diagnostic confidence among ILD patients suspected of IPF as well as patients with noninformative histopathology, potentially avoiding invasive and risky surgical procedures.