Veracyte presented early data from a real-world clinical test showing that its Envisia Genomic Classifier is an efficient tool for diagnosing idiopathic pulmonary fibrosis (IPF) without invasive and expensive surgery.
These preliminary results were in a poster titled “The CATALYST Study: A Clinical Utility Analysis of the BRAVE (Bronchial Sample Collection for A Novel Genomic Test) Registry, using the Envisia Genomic Classifier,” presented at the recent Pulmonary Fibrosis Foundation’s biannual PFF Summit, Nashville, Tennessee.
IPF is challenging to diagnose and distinguish from other interstitial lung diseases (ILDs), possibly delaying a patient’s treatment. With the classifier, clinicians may diagnose the disease according to a person’s genetic data.
“These findings signal a real potential for a shift in the current diagnostic evaluation of patients undergoing evaluation for ILD,” Neil M. Barth, chief medical officer of Veracyte, said in a press release.
Envisia uses a less-invasive procedure — called bronchoscopy — to obtain tissue samples and then analyze 190 genes to determine if the samples carry a signature of usual interstitial pneumonia, a well-known histopathologic hallmark of IPF.
In the CATALYST clinical study, still underway, researchers are evaluating Envisia Genomic Classifier performance in a real-world clinical setting. They’re comparing the efficacy of diagnosis between conventional methods — including high-resolution computed tomography images and lung tissue analysis obtained by surgery — with Envisia’s genetic analysis.
Preliminary results from 71 patients showed that two multidisciplinary teams of clinicians — composed of a pulmonologist, radiologist and pathologist — reached similar rates for IPF diagnosis (a 92% agreement) when they reviewed surgical results or Envisia classifier results together with clinical information and high-resolution computed tomography scans.
Even in the absence of conclusive surgical results, the Envisia classifier led to a 94% agreement in IPF diagnosis by the multidisciplinary teams.
“Prior to the introduction of the Envisia classifier, clinicians and patients were limited to surgery for confirming a diagnosis of IPF, if the HRCT [high-resolution computed tomography] was inconclusive,” Barth said.
“Many patients are not willing or medically eligible to undergo such an invasive procedure. Envisia has now been shown to enable as confident a diagnosis in IPF as surgical pathology. This removes many of the previous barriers to achieving a timely and accurate diagnosis,” he added.