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Veracyte Secures NY State Approval for Genomic Classifier Test for Lung Disease
May 2, 2019Veracyte has received regulatory approval from the New York State Department of Health to offer its Envisia Genomic Classifier test to patients in the state. 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.