A genomic test called Envisia genomic classifier increases the diagnostic accuracy of idiopathic pulmonary fibrosis (IPF) as well as the confidence of the physicians in their diagnosis and referring patients to the right therapy, according to the results of a prospective, randomized survey among pulmonologists. These results were presented at the American College of Chest Physicians (CHEST) Annual Meeting 2021 on October 18.

According to Veracyte, the company that developed the system, the Envisia genomic classifier positively impacts clinical decision-making in IPF. 

Joseph Lasky, MD, the leader of the study, stated, “Given the progressive nature of IPF, accurate, timely diagnosis and initiation of antifibrotic therapy for patients who may benefit is critical.” He added, “These findings suggest that the Envisia classifier can facilitate this difficult diagnosis, potentially enabling physicians to more effectively care for patients and improve their outcomes.”

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During the study, the researchers surveyed 103 practicing pulmonologists. Their aim was to determine the how Envisia classifier impacted the decision of the pulmonologists in terms of IPF diagnosis. Eighty-one physicians reviewed the cases of 5 patients to determine a diagnosis of interstitial lung disease without access to Envisia test results. They then reviewed the cases with the results of the Envisia test included. 

The results showed that pre-Envisia, IPF diagnosis was 30%. This increased to 69% post-Envisia testing. 

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When the researchers focused on patients whose high-resolution computed tomography (HRCT) pattern was indeterminate or most consistent with a non-IPF diagnosis, the IPF diagnosis increased from 4.5% to 54.5% after Envisia testing.

The Envisia classifier also significantly increased physicians’ confidence in their diagnoses, with the number of physicians saying they had a high level of confidence in their diagnosis increasing from 5.8% to 42% after Envisia.

Physicians recommending treatment to patients increased from 12% to 50% post-Envisia, and the recommendation of a surgical lung biopsy decreased from 26% to 17%.

The Envisia classifier compares genomic patterns in samples collected from patients using a transbronchial biopsy. The test is designed to distinguish usual interstitial pneumonia, a typical IPF pattern, from other interstitial lung diseases.


New clinical utility data confirm Veracyte’s Envisia genomic classifier increases accuracy and confidence in IPF diagnosis. News release. Veracyte; October 11, 2021.