Envisia IPF Diagnostic Tool Increases Accuracy, Doctor’s Confidence

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A new diagnostic tool, the Envisia Genomic Classifier, can help make doctors more confident and accurate in diagnosing idiopathic pulmonary fibrosis (IPF), a new survey suggests.

Using the Envisa tool, by Veracyte, also may help in increasing the proportion of patients referred to proper treatment, the survey found.

“Physicians and patients need more objective, accurate tools to diagnose [interstitial lung diseases] and IPF so that patients can receive appropriate treatment and avoid further, invasive procedures such as surgical lung biopsy,” Marc Stapley, CEO of Veracyte, said in a press release.

“The new data … suggest that the Envisia classifier can help address this long-standing clinical gap, enabling physicians and patients to make better, faster and more confident care decisions,” Stapley said.

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One of the hallmark signs used to diagnose IPF — and to distinguish it from other diseases that cause lung tissue scarring (fibrosis) — is a particular pattern of lung damage called usual interstitial pneumonia (UIP). Often, UIP can be identified with lung imaging, but some patients may have ambiguous imaging results.

The Envisia classifier is designed to identify UIP by assessing the genetic activity of cells to look for patterns associated with this type of lung damage.

To better understand how this test may help in the diagnosis of IPF, researchers surveyed a group of pulmonologists using data from five ILD patient case studies. The survey results will be shared in an oral presentation, titled “The Impact of the Envisia Genomic Classifier in the Diagnosis and Management of Patients with Interstitial Lung Disease,” at the American College of Chest Physicians (CHEST) Annual Meeting, taking place Oct. 17–20.

After providing the pulmonologists with data from the patient cases, the researchers asked these lung specialists what diagnosis they would make, based on the data, as well as how confident they were in their decision. Patient cases were randomly taken from a set of 11 relatively complex cases in which patients were ultimately diagnosed with IPF after a thorough review by a team of specialists.

Notably, in all of the cases, lung imaging did not show a definitive sign of UIP: in some patients, lung imaging results were suggestive of UIP, while in others, the patterns were either unclear or inconsistent with UIP.

The pulmonologists were asked to make decisions about the diagnoses twice: first, without taking into account the results of the Envisia test, and then again with the data it generated.

A total of 81 pulmonologists in the U.S. answered the survey. The total number of correct IPF diagnoses increased from 30% without Envisia results to 69% with the test. Significant increases were seen regardless of whether lung imaging was probably, unclear, or inconsistent with UIP.

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The number of diagnoses for which pulmonologists said they were highly confident also increased from 5.8% to 42% following the addition of the Envisia test.

Recommendations for initiating anti-fibrotic treatment similarly increased from 12% to 50%, while recommendations to conduct a surgical lung biopsy — a highly invasive test that can help diagnose IPF — decreased from 26% to 17%.

“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,” said Joseph Lasky, MD, of Tulane University Medical School, who will present the results at the meeting.

“Given the progressive nature of IPF, accurate, timely diagnosis and initiation of antifibrotic therapy for patients who may benefit is critical,” Lasky added.

According to Veracyte, about 200,000 patients each year in the U.S. and Europe have “unclear results” following their assessments for ILDs, including IPF.

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