Real-world Data Support Envisia Classifier in More Easily Diagnosing IPF

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by Patricia Inacio PhD |

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Veracyte’s Envisia Genomic Classifier can aid in the diagnosis of idiopathic pulmonary fibrosis (IPF) and distinguish it from other interstitial lung diseases (ILDs) without the need for invasive, expensive, and risky surgical procedures, real-world data confirm.

These findings were presented in two posters at the American Thoracic Society (ATS) 2020 Virtual conference.

“These results demonstrate that the Envisia Genomic classifier can improve upon standard of care for IPF diagnosis, enabling physicians to diagnose the disease less invasively and with more confidence,” Amy Hajari Case, MD, a Piedmont physician involved in the studies, said in a press release.

“This is meaningful, because it enables patients to more quickly receive appropriate treatment for this progressive disease,” Case added.

ILD is an umbrella term for conditions that involve fibrosis (scarring) of the lungs, leading to poorer lung function. IPF is the most common of all ILDs, but also one of the hardest to diagnose.

An early and accurate diagnosis is critical to improve the effectiveness of anti-fibrotic treatments in delaying a decline in lung health and fibrosis progression.

According to Veracyte, Envisia is the first commercially available genomic tool for diagnosing IPF and differentiating it from other ILDs, a process that commonly requires surgery.

The test combines RNA sequencing analysis with machine learning to detect the presence or absence of usual interstitial pneumonia (UIP), a classic diagnostic pattern that is essential for the diagnosis of IPF, in transbronchial biopsies — small lung tissue samples collected during a bronchoscopy, a method that is less invasive than surgery.

In both posters presented at ATS 2020, researchers evaluated the efficacy and accuracy of Envisia in patients enrolled in a Bronchial Sample Collection for a Novel Genomic Test (BRAVE) trial group.

These people had been previously evaluated for a potential IPF diagnosis by combining surgical tissue sample collection with experts’ classifications on UIP or non-UIP based on high-resolution computed tomography (HRCT). These results were used as reference.

In the first poster — titled “A Follow-Up On Prospective Clinical Validation of the Envisia Genomic Classifier” — researchers sought to validate the clinical value of Envisia.

They analyzed 96 patients (41 women and 55 men, mean age of 62.8), finding Envisia was able to detect UIP with a specificity of 92.1% and a sensitivity of 60.3% when combined with HRCT. In this group, Envisia detected an UIP prevalence of 60.4%.

Of note, a test’s sensitivity is its ability to correctly identify those with a given disease, while specificity refers to correctly identifying those without it.

In the second poster — titled “Performance and Clinical Utility of the Genomic Classifier (Envisia) for Usual Interstitial Pneumonia in Conjunction with Local Radiology” and presented by Case — researchers explored whether combining the results from Envisia with that of HRCT would improve the diagnosis of UIP when compared to HRCT alone.

A total of 85 patients from the BRAVE cohort with available HRCT scans and tested with Envisia were included. In this cohort, UIP had a prevalence of 62.4%.

Results showed that combining Envisia with HRCT data enhanced UIP diagnosis sensitivity when compared to HRCT alone, from 34% in HRCT alone to 79.2%.

“In this prospective multi-center clinical validation study, the diagnostic accuracy and yield for a UIP pattern was substantially improved when the Envisia Classifier was used as a complement to local radiology,” the researchers wrote in the poster.

At ATS 2020, Veracyte also showed that another of its diagnostic tools, called Percepta Genomic Sequencing Classifier, can improve bronchoscopy’s standard of care in diagnosing lung cancer.

“Collectively, the data presented at ATS 2020 provide additional clinical evidence that the Percepta and Envisia classifiers can improve the diagnosis of lung cancer and IPF,” said Bonnie Anderson, Veracyte’s chairwoman and CEO.

“Supporting more effective and efficient care has become even more important in the current healthcare landscape and we believe will help fuel further physician adoption and payer reimbursement for our tests,” Anderson added.

Veracyte is preparing to launch the Envisia test in global markets in late 2021.

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