Veracyte Inc, San Francisco, has announced receipt of a final Medicare local coverage determination for its Envisia genomic classifier. The determination was issued through the Palmetto GBA MolDx program and becomes 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 idiopathic pulmonary fibrosis (IPF), and is Veracyte’s third genomic test to receive a Medicare coverage 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,” says 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 the progression of IPF, 55% of IPF and ILD patients report being misdiagnosed at least once, and, for one in five patients, accurate diagnosis took 3 years or more, according to a study by the Pulmonary Fibrosis Foundation. Veracyte estimates that half of the patients evaluated in the United States for ILDs, including IPF, are covered by Medicare.

The Envisia genomic classifier helps differentiate IPF from other ILDs without the need for surgery. The test is used as a complement to high-resolution computed tomography scanning to enable clinicians to make a more confident diagnosis. Envisia evaluates patient samples that are obtained through transbronchial biopsy, a nonsurgical procedure that is commonly used in lung evaluation. The test is proven to detect a genomic pattern of usual interstitial pneumonia, a hallmark of IPF, with high accuracy.

“A common theme in my conversations with other IPF patients is that we faced significant challenges in obtaining an accurate diagnosis,” notes 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.”

For further information, visit Veracyte.