NEW YORK (GenomeWeb) – Veracyte said today that Medicare administrative contractor Palmetto GBA MolDx has issued a final local coverage determination for use of its Envisia Genomic Classifier assay to clarify the diagnosis of patients with interstitial lung disease who are suspected of having idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis is a common interstitial lung disease, but often requires a lung biopsy to diagnose. Clarifying the diagnosis is important because IPF results in progressive decline of pulmonary function until respiratory failure. IPF is marked by a pattern of usual interstitial pneumonia (UIP) that can be revealed by imaging tests, but such tests often do not result in a definitive diagnosis and the next step would be to perform an invasive lung biopsy.
According to the LCD policy, the Envisia test is intended to be used in patients for whom imaging results in an indeterminate or a probable UIP pattern, but not in patients without IPF or in patients who have a typical pattern of UIP.
The goal of the test, which analyzes expression of 190 genes, is to help clarify the diagnosis of UIP so that patients are not subjected to unnecessary lung biopsy surgeries.
"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," Veracyte CEO Bonnie Anderson said in a statement.
Palmetto noted in its LCD that the assay was "quite promising" and that continued coverage for Envisia testing is dependent on an annual review of the data and publications.