Envisia Test May Help Identify ILD Patients With Progressing Disease

These patients could benefit from earlier treatment before irreversible lung decline

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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A test by Veracyte can be used to predict which patients with interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF), are more likely to experience progressive decline in their lung function, according to new data.

Called the Envisia Genomic Classifier, the test works by identifying the genomic signature of usual interstitial pneumonia (UIP), a pattern of lung disease that is considered a hallmark of IPF and can also be present, although less commonly, in other types of lung disease.

New data indicated that for ILD patients in whom UIP was identified, lung function was worse, and declined more quickly over a one-year period, compared with UIP-negative patients.

“Importantly, the Envisia test may help identify patients with progressive pulmonary fibrosis who could potentially benefit from earlier therapy before they might experience significant, irreversible loss of lung function,” Lisa Lancaster, MD, professor of medicine at Vanderbilt University Medical Center, said in a press release.

Lancaster presented the findings at the American College of Chest Physicians (CHEST) Annual Meeting, held in Nashville, Tennessee, Oct. 16–19. The poster was titled “Positive Envisia Genomic Classifier Result Predicts Clinical Progression In Fibrotic Interstitial Lung Disease.”

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Non-invasive tool to identify usual interstitial pneumonia

IPF is one of several forms of ILD, all of which are marked by inflammation and scarring in the lungs. UIP is a particular pattern of lung disease that is an essential criterion for diagnosing IPF.

Normally, UIP is identified with imaging techniques, and if those are inconclusive, surgery to obtain lung tissue may be required.

The Envisia Genomic Classifier seeks to identify UIP accurately without the need to resort to invasive procedures. Basically, a transbronchial biopsy is performed, in which a small flexible tube is inserted into the lungs via the nose or mouth, to collect a tissue sample. That sample is then sent to Envisia’s lab, where it is genetically analyzed to determine whether the genetic signature of UIP is present.

Veracyte has previously demonstrated that the tool can help doctors make a more accurate IPF diagnosis.

The classifier may also have benefits beyond the initial diagnosis. A previous analysis of 135 patients from the Bronchial Sample Collection for a Novel Genomic Test (BRAVE) clinical study demonstrated that patients with suspected ILD with a UIP-positive test result had faster disease progression when treated with immunosuppressants — a finding that could help physicians make treatment decisions because some immunosuppressants used to treat many types of ILD are actually harmful to patients with IPF.

Lancaster’s presentation also concerned the 135 patients from the BRAVE study but this time, investigators set out to examine whether a UIP-positive test result could be used as a biomarker of disease progression.

Lung function was evaluated with forced vital capacity (FVC), a measure of how much air can be forcibly exhaled in a single breath.

Overall, 73 patients had a UIP-positive result with the genomic classifier. Results showed that these patients had worse lung function at the study’s start (baseline), and showed greater declines over the next year, compared with UIP-negative patients.

Specifically, these 73 people had a baseline FVC value of 66.9%, which declined by 3.7% over the course of one year. By comparison, patients who were negative for UIP had a baseline FVC of 73.4%, which declined by 0.1% over the next year.

Disease progression was observed even in patients who did not show definitive signs of the condition using other diagnostic techniques but were positive for UIP on the Envisia test.

“Our findings suggest that a positive Envisia test result may serve as a biomarker for FVC decline by identifying the genomic signature of UIP in patients whose CT scans do not reveal definitive UIP,” Lancaster said.

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Researchers noted that the test may help clinicians identify which ILD patients may require prompt treatment with anti-fibrotic therapies.

“The data presented at the CHEST 2022 meeting reinforce our commitment to driving innovation that can help physicians make better care decisions for their patients,” said Bill Bulman, MD, medical director of pulmonology at Veracyte.

“These findings suggest that, beyond helping to diagnose IPF, our Envisia test may also help to identify progressive disease in patients with other forms of ILD,” Bulman added.

The test is currently only available in Envisia’s U.S. laboratories, but the company plans to expand access to global markets in the future.

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