NEW YORK (GenomeWeb) – Veracyte today said it has launched an early-access program for its Envisia Genomic Classifier test for idiopathic pulmonary fibrosis. The test uses RNA sequencing and machine learning to analyze 190 genes involved in usual interstitial pneumonia, a feature of IPF, with 88 percent specificity and 70 percent sensitivity.
Veracyte published a clinical validation of the test last year in the Annals of the American Thoracic Society and CEO Bonnie Anderson has previously said that the firm expects to gain Medicare coverage for the test prior to the full commercial launch in 2019.
Initial early-access users include physicians from Philadelphia University, Thomas Jefferson University, Keck Medicine of the University of Southern California, Providence Sacred Heart Medical Center in Washington, and the University of California, Los Angeles.
Diagnosing IPF is difficult even with advanced imaging technologies, yet, "diagnostic surgery is risky, expensive, and may not be viable for some patients," S. Samuel Weigt, director of the UCLA Health's Interstitial Lung Disease Center, said in a statement. "Obtaining an accurate, timely IPF diagnosis is important given the availability of new drugs that can slow the progression of this debilitating disease, as well as the need to avoid inappropriate and potentially harmful treatment."
"Multiple studies have demonstrated that the Envisia Genomic Classifier supports more confident IPF diagnosis and optimal patient management," Anderson said.