Envisia Test May Predict Who Will Progress on Immunosuppressants

The test helps clinicians diagnose IPF by looking at samples from a transbronchial biopsy

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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A molecular test, called the Envisia Genomic Classifier, may predict which patients with idiopathic pulmonary fibrosis (IPF) will progress on immunosuppressants, which could help doctors decide who will more likely benefit from antifibrotic therapy.

The test, developed by Veracyte, can tell IPF from other types of interstitial lung diseases (ILDs) by looking at the genetic signature of usual interstitial pneumonia (UIP), a hallmark of IPF.

These findings are important because some immunosuppressants used to treat many types of ILD are actually harmful to patients with IPF, while there are antifibrotic medications that may slow the disease’s progression.

“Determining which patients have IPF or an ILD that will progress is often challenging. This can lead to treatment delays or, worse, empirical treatment with immunosuppressant therapy that may be harmful to some patients with progressive disease,” Athol Wells, MD, PhD, consultant chest physician at Royal Brompton Hospital, London, said in a press release.

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“Our findings suggest that the Envisia Genomic Classifier can identify patients whose ILD is likely to progress with combination immunosuppressive therapy and who thus could potentially benefit from antifibrotic therapy,” Wells said.

Wells presented these findings in a poster at the European Respiratory Society International Congress 2022, Sept. 4–6 in Barcelona, Spain.

IPF occurs when the lungs become scarred for an unknown reason, making it hard for patients to breathe. Diagnosing it may be difficult because symptoms can overlap with those of other lung diseases.

Doctors usually use imaging tests to look for UIP. These tests sometimes yield inconclusive results and surgery, to collect small pieces of lung tissue, may be needed to reach a final diagnosis.

The Envisia Genomic Classifier helps clinicians diagnose IPF by looking at samples obtained through a transbronchial biopsy and it can do so by spotting UIP with a specificity of 91% and a sensitivity of 63%. During a transbronchial biopsy, a flexible tube, called a bronchoscope, is inserted through the nose or mouth to collect small pieces of lung tissue, without the need for invasive surgery.

A positive result can make doctors feel more confident about an IPF diagnosis and help them make more informed decisions about an initial treatment plan.

Researchers looked at data from 135 patients who had taken part in the Bronchial Sample Collection for a Novel Genomic Test (BRAVE) clinical study. All had undergone an evaluation for a suspected ILD. The evaluation included an Envisia Genomic Classifier test and multiple measurements of forced vital capacity to assess lung function over time. Forced vital capacity is a lung function parameter that measures the total amount of air a person can exhale after a deep breath.

Researchers found that patients with a positive UIP result on the Envisia Genomic Classifier test who had been treated with a combination of immunosuppressants had  a greater lung function decline compared with those who didn’t receive immunosuppressants (9.4% vs. 1.9%).

There was no difference in lung function decline between patients who had a negative test result for UIP and were being treated with a combination of immunosuppressants and those who did not take those medications.

“These findings highlight how Veracyte’s Envisia Genomic Classifier can provide information that goes beyond diagnosing IPF, providing valuable insights that suggest how ILD patients may respond to different treatment options,” Bill Bulman, MD, Veracyte’s medical director of pulmonology, said.

Findings were similar regardless of the description made by a pathologist based on lung tissue images seen under a microscope. This means that the Envisia Genomic Classifier may help track the progression of the disease even when its manifestations are not apparent.

“These results further support the clinical utility of the Envisia test, highlighting its potential to help inform diagnosis, prognosis, and treatment decisions by identifying patients with UIP, helping some patients avoid potentially harmful therapy,” Bulman said.

The test is currently only run at Veracyte’s lab in the U.S., but the company plans to make it available to global markets so that other labs can use it. An application for regulatory approval in Europe is expected to be filed next year.

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