Veracyte Inc has received a final Medicare local coverage determination (LCD) for the Envisia Genomic Classifier, a genomic diagnostic for idiopathic pulmonary fibrosis (IPF).
The policy was issued through the Palmetto GBA MolDx program and will become effective April 1, 2019, making the Envisia classifier covered for the nation’s 55 million Medicare patients. The Envisia classifier is the first commercially available test of its kind to improve diagnosis of IPF and is Veracyte’s third genomic test to receive a Medicare-covered designation since the company’s founding in 2008.
“We are pleased that the evidence supporting the Envisia classifier met the MolDx program’s high standards for coverage,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “This important milestone will enable us to begin making the Envisia Classifier more widely available to patients with suspected IPF so that they can obtain an accurate, timely diagnosis and, in turn, appropriate treatment.”
Over 100,000 people in the United States have lung-scarring interstitial lung diseases (ILDs), including IPF, which is the deadliest type, and the number is rising. While therapies are now available to slow progression of IPF, 55% 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. Veracyte estimates that half of the patients evaluated for ILDs, including IPF, in the United States are covered by Medicare.
“A common theme in my conversations with other IPF patients is that we faced significant challenges in obtaining an accurate diagnosis,” said Bill Vick, who founded the advocacy group PF Warriors after receiving an IPF diagnosis in 2011. “A tool that can provide more clarity in this diagnosis will alleviate anxiety for patients and, importantly, enable them to get appropriate treatment faster so that they have the potential to live longer, fuller, more productive lives.”