Genomic classifier facilitates accurate IPF diagnoses
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Use of the Envisia Genomic Classifier impacted physician decision-making for evaluation of interstitial lung disease by increasing the number of correct idiopathic pulmonary fibrosis diagnoses that were made with high confidence.
Moreover, the Envisia Genomic Classifier (Veracyte) increased physician recommendations for antifibrotic therapy, according to data presented at the CHEST Annual Meeting.
“The diagnosis of IPF ... remains challenging and often results in delayed or misdiagnosis that ultimately leads to worse outcomes,” Joseph Lasky, MD, professor of medicine and pulmonary/critical care section chief at Tulane University Medical School, said during a presentation.
IPF diagnosis is based on a radiographic or histologic “usual interstitial pneumonia” pattern in the absence of an identifiable etiology, Lasky said. The Envisia Genomic Classifier is a clinically validated molecular diagnostic test that detects usual interstitial pneumonia pattern using whole transcript sequencing in transbronchial biopsies. The classifier consists of 190 genes. It was created as a rule-in test for usual interstitial pneumonia pattern, according to Lasky. In two previous independent validation studies, the classifier had a combined specificity of 91% and sensitivity of 63%, he said.
The current study evaluated the impact of the classifier on physician decision-making. The prospective, randomized, decision-impact survey included 11 patient cases with undiagnosed ILD. Each case had a CT scan without a typical usual interstitial pneumonia pattern, a positive result for usual interstitial pneumonia using the classifier and underwent multidisciplinary team discussion that resulted in a final diagnosis of IPF.
The survey was answered by 103 U.S. pulmonologists, who each reviewed five randomly selected cases. For each case, physician reviewers were asked to determine an ILD diagnosis, rate their confidence level of the diagnosis and determine the next management step.
The study had a pre- and post-Envisia cohort and an independent cohort. The pre- and post-Envisia cohort was given the case without the classifier, then given the classifier result and then given the case again. The independent cohorts were either given the case with the classifier result or not, Lasky said.
The number of IPF diagnoses increased with the classifier (P < .001 with the pre- and post-cohort; P = .046 with the independent cohorts). Diagnoses were more than doubled in the pre- and post-Envisia cohort, Lasky said.
High physician confidence (> 90%) of IPF diagnosis was more common when the classifier was included (P < .001 with the pre- and post-cohort; P = .008 with the independent cohorts). In the pre- and post-Envisia cohort, confidence level pre-Envisia was 5.8% and increased to 42% after the classifier was included (P < .0001), according to the results.
Recommendations to initiate treatment were also increased when the classifier was included.
Antifibrotic therapy was the most common treatment choice with and without the classifier, Lasky said.
“The Envisia Genomic Classifier has a significant impact on physicians’ clinical decision-making in the diagnosis and management of patients with ILD. The Envisia [usual interstitial pneumonia pattern positive] results increased the number of IPF diagnoses and the confidence of these diagnoses, leading to increased recommendation for antifibrotic therapies without the need for more invasive procedures, including surgical lung biopsy and cryobiopsy. By facilitating an IPF diagnosis, the Envisia Genomic Classifier will enable physicians to more effectively manage patients with ILD, leading to improved patient outcomes,” Lasky said.