Envisia™ Genomic Classifier
Increasing Confidence in Idiopathic Pulmonary Fibrosis Diagnosis

The Envisia Genomic Classifier is the first commercially available genomic test to improve the diagnosis of idiopathic pulmonary fibrosis (IPF). The test harnesses the power of RNA sequencing and machine learning to improve physicians’ ability to differentiate IPF from other interstitial lung diseases (ILD) without the need for invasive, risky and costly surgery.

Each year across the United States and Europe, up to 200,000 patients are suspected of having an ILD. IPF is among the most common and most deadly of these lung-scarring diseases. It is notoriously difficult to diagnose, often leading to treatment delays, prolonged misdiagnosis, patient distress and added healthcare expense. Obtaining a timely IPF diagnosis is important, particularly given the recent availability of therapies that can slow the progression of the disease and recent data showing that traditional therapies for most ILDs are actually harmful to patients with IPF.

Limitations in current technologies make IPF challenging to differentiate from other ILDs. Physicians routinely use high-resolution computed tomography (HRCT) to help identify a hallmark pattern of IPF known as usual interstitial pneumonia (UIP), but this approach frequently provides inconclusive results, which can lead to surgical lung biopsy or other invasive diagnostic procedures.
The Envisia Genomic Classifier combines RNA sequencing and machine learning to improve physicians’ ability to distinguish IPF from other ILDs through patient samples that are obtained using transbronchial biopsy, a nonsurgical procedure that is commonly used in lung evaluation. The 190-gene test detects the genomic pattern of UIP with high accuracy (88 percent specificity and 70 percent sensitivity, compared to 43 percent sensitivity for HRCT).

In May 2018, Veracyte initiated an Early Access Program, making the Envisia classifier available to patients through a limited number of leading institutions. The company plans to expand commercialization of the test nationwide in 2019.

Learn more about offering Envisia through our Early Access Program.

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