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Veracyte Secures NY State Approval for Genomic Classifier Test for Lung Disease

NEW YORK (GenomeWeb) – Veracyte has received regulatory approval from the New York State Department of Health to offer its Envisia Genomic Classifier test to patients in the state immediately, the company said on Monday. The test uses RNA sequencing and machine learning to help distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILD) without surgery.

The approval follows the publication of a clinical study of the assay earlier this month and a Medicare local coverage determination for Envisia last month to be used as a complement to high-resolution computed tomography in some cases.

"This milestone, along with a recent Medicare coverage policy, underscores the strength of the clinical evidence behind the Envisia classifier and the critical need for better diagnosis among patients being evaluated for ILDs, including IPF," Veracyte CEO Bonnie Anderson said in a statement.