Veracyte, Inc. announced that data published online in The Lancet Respiratory Medicine suggest that use of the company’s Envisia Genomic Classifier improves diagnosis for patients undergoing evaluation for interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF). The Envisia classifier is a commercially available test that may help distinguish IPF from other ILDs, without the need for risky surgery. The Envisia classifier recently received Medicare coverage.
Over 100,000 people in the United States have lung-scarring ILDs, including IPF, which is the deadliest type, and the number is rising. While therapies are now available to slow progression of this deadly disease, 55 percent of IPF/ILD patients reported being misdiagnosed at least once and, for one in five patients, accurate diagnosis took three or more years, according to a study by the Pulmonary Fibrosis Foundation.
The new paper includes data from a clinical validation and a clinical utility study, both conducted using data from patients enrolled in the ongoing, prospective, 29-site, blinded BRAVE (Bronchial Sample Collection for a Novel Genomic Test) study. The clinical validation study assessed the Envisia classifier’s ability to identify the usual interstitial pneumonia (UIP) pattern, whose presence is essential to IPF diagnosis. Among 49 patients who met the study criteria (and were not used to train the genomic classifier algorithm), the Envisia classifier achieved a specificity of 88 percent and sensitivity of 70 percent for UIP. These findings mean that the test would be expected to identify more than two-thirds of UIP cases with a high degree of accuracy, while minimizing the number of false positive results, providing physicians with greater confidence in their diagnosis. In comparison, data show that high-resolution CT (HRCT) imaging, which is typically used in IPF diagnosis, has a sensitivity of just 43 percent for UIP.
In the clinical utility study, known as CATALYST (Clinical Utility Analysis of a UIP Genomic Classifier in the BRAVE Trial), two multidisciplinary teams (MDTs) conducted blinded reviews of 94 study participants’ medical charts. Researchers found that when the Envisia classifier was used as a complement to HRCT in an MDT evaluation, there was high agreement (86 percent) in IPF versus non-IPF diagnoses when evaluating the same patients with HRCT and surgical histopathology results. Further, when both MDTs made an IPF diagnosis, the authors observed that the MDT with Envisia classifier results was significantly more confident in its IPF diagnosis compared to the team with surgical histopathology results (89 percent versus 56 percent).
