Exceptional diagnostic testing for interstitial lung disease (ILD)

The Envisia® Genomic Classifier detects a genomic usual interstitial pneumonia (UIP) pattern to help improve ILD diagnostic and prognostic confidence.

Envisia website
  • Screening
  • Diagnosis
  • Prognosis/​treatment selection
  • Recurrence monitoring

Envisia

IMPROVING CARE FOR ILD PATIENTS

The Envisia test helps increase ILD diagnostic and prognostic confidence

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The Envisia Genomic Classifier is the first commercially available genomic test to help improve physician confidence in the diagnosis and prognosis of interstitial lung disease (ILD). The test uses powerful RNA sequencing and machine-learning technology to identify a genomic pattern of usual interstitial pneumonia (UIP). UIP is often difficult to identify, yet is critical to the diagnosis of idiopathic pulmonary fibrosis (IPF), one of most common and deadly types of ILD. UIP also helps identify non-IPF patients whose ILD is likely to progress.1-3 Timely and accurate diagnosis is important so these patients can receive antifibrotic therapy that may slow progression of the disease and so that they can avoid potentially harmful treatment.

An older couple embrace and laugh together at dinner.

WHEN THE TEST IS USED

Designed as a complement to high-resolution computed tomography (HRCT) and clinical factors

The Envisia test is used as a complement to HRCT in patients with suspected ILD. Lung tissue is collected during a bronchoscopy, a common nonsurgical procedure, and sent to Veracyte for genomic testing. The Envisia test reports the results as either positive or negative for UIP. Patients that are positive for UIP will typically be treated with antifibrotic therapy.4 Those who are negative for UIP will typically continue their diagnostic work-up.

Envisa logo

UIP-POSITIVE

May likely be treated with antifibrotic therapy

UIP-NEGATIVE

May likely continue their diagnostic work-up

Clinical data for the Envisia Genomic Classifier

The Envisia Genomic Classifier is supported by multiple published studies demonstrating its clinical performance and utility. In two independent, prospective, multicenter clinical validation studies, the Envisia classifier identified UIP with a combined specificity of 91%,5,6 compared to histopathology as a reference. Additionally, data show that the Envisia test combined with HRCT identified twice as many UIP patients compared to HRCT alone.5 Further, data revealed that use of Envisia enabled a multi-disciplinary team to make an IPF or non-IPF diagnosis with similar confidence to if they had reviewed histopathology slides.5 In other words, Envisia can provide important information to inform ILD diagnosis and prognosis without the need for surgery.

91%

specificity compared to histopathology5,6

>2X

improved ability of Envisia plus HRCT to identify UIP, compared to radiology alone.5

FEATURED PUBLICATIONS

In AJRCCM: “Utility of a Molecular Classifier as a Complement to High-Resolution Computed Tomography to Identify Usual Interstitial Pneumonia”

AJRCCM article

In The Lancet Respiratory Medicine: “Use of a Molecular Classifier to Identify Usual Interstitial Pneumonia in Conventional Transbronchial Lung Biopsy Samples: A Prospective Validation Study”

The Lancet Respiratory Medicine article
All clinical data

Serving patients across the US and beyond

Envisia is currently available in the US, where the test is performed in Veracyte’s centralized CLIA laboratory. The test is covered by Medicare, and Veracyte bills Medicare and third-party payers directly. The Veracyte Access Program provides financial support for eligible patients based on financial need.

Veracyte is in the process of making the Envisia test available to patients outside of the US by offering it as an in vitro diagnostic (IVD) test that can be performed locally by labs worldwide.

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A physician attends to an older patient lying in a hospital bed.
A physician listens to an older patient’s chest with a stethoscope.

Learn about the Envisia test for ILD diagnosis and prognosis

Envisia website

REFERENCES

  1. Kim E, et al. Eur Respir J. 2010.

  2. Kim E, et al. CHEST. 2009.

  3. Wang P, et al. CHEST. 2017.

  4. Chaudhary S, et al. Eur. Respir. J. 2023.

  5. Richeldi L, et al. AJRCCM. 2020.

  6. Raghu G, et al. Lancet Respir. Med. 2019.

The Envisia Genomic Classifier is available in the US as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared or approved by the FDA.

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