Veracyte recently announced that results from a study supporting the development of the Envisia Genomic Classifier, a genomic test used to improve the diagnosis of idiopathic pulmonary fibrosis (IPF), have been published in the journal Annals of the American Thoracic Society.
IPF is a severe form of interstitial lung disease. The condition is difficult to diagnose, and often requires an invasive and potentially risky surgery for a definitive diagnosis. Up to 200,000 patients in the United States and Europe are evaluated for interstitial lung diseases, including IPF, each year.
Although clinicians can use high-resolution computed tomography (HRCT) to aid in the diagnosis, the results can be inconclusive, and patients often need to undergo invasive surgery for a proper diagnosis. If patients are not eligible for surgery they may never receive an accurate diagnosis, which can lead to suboptimal treatment.
In the study, the genomic classifier was successfully used to identify patients with a histologic pattern of usual interstitial pneumonia (UIP) — a key finding essential to an IPF diagnosis — without the need for surgery.
The classifier, which uses machine learning and whole-genome RNA sequencing, was used to evaluate 283 transbronchial biopsies (TBB, a less invasive procedure in which a thin, lighted tube is inserted through the nose or mouth to collect lung tissue) from 84 patients who were enrolled in a prospective, multicenter trial known as the BRAVE study.
The Envisia Genomic Classifier was found to have a specificity of 86 percent and a sensitivity of 63 percent, suggesting that the test could identify nearly two-thirds of patients with UIP with a high degree of accuracy.
“These strong early results informed the development of our commercialized Envisia Classifier, which we believe can help significant numbers of patients with suspected IPF obtain a more timely, accurate and safer diagnosis,” Bonnie Anderson, Veracyte’s chairman and CEO, said in a press release.
“These newly published findings also reinforce the scientific and clinical rigor that went into the Envisia Classifier’s development. We believe that this foundational work, along with the robust clinical validation data we have shared in recent months, will build the body of published evidence needed to drive physician adoption and payer reimbursement of the Envisia Genomic Classifier test.” Anderson added.
Researchers recently announced at the American Thoracic Society (ATS) 2017 International Conference that the commercialized version of the Envisia Classifier was even more sensitive and specific than the prototype used in the study.