The Envisia Genomic Classifier, produced by Veracyte, has received final Medicare local coverage determination for the diagnosis of idiopathic pulmonary fibrosis (IPF).
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Envisia is a complement to high-resolution CT that can help differentiate IPF from other interstitial lung diseases, as more than half of patients with IPF/interstitial lung disease report being misdiagnosed at least once. The test analyzes samples obtained through transbronchial biopsy, a nonsurgical procedure commonly used in lung evaluation. Envisia has been shown to detect usual interstitial pneumonia, a signature of IPF, with high accuracy.
The new policy was issued through the Palmetto GBA MolDx program and will go into effect on April 1, 2019, making Envisia the first commercially available test of its kind, available to the 55 million people who are currently enrolled in Medicare.
“We are pleased that the evidence supporting the Envisia classifier met the MolDx program’s high standards for coverage. 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,” Bonnie Anderson, chairman and chief executive officer of Veracyte, said in a press release.
Find the full press release on the Veracyte website.