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Veracyte Gets Draft Medicare Local Coverage Determination for Envisia Test

NEW YORK (GenomeWeb) – Veracyte said after the close of the market on Thursday that it has received a draft Medicare local coverage determination through MolDx for its Envisia Genomic Classifier test, which uses RNA sequencing and machine learning technology to diagnose idiopathic pulmonary fibrosis.

The Wisconsin Physicians Service Insurance Corporation posted its draft LCD online and Veracyte said it anticipates that three other Medicare Administrative Contractors — CGS, Noridian Health Solutions, and Palmetto GBA — would follow suit.

"The evidence supporting use of the Envisia classifier met MolDx's high bar for coverage and strongly positions us to expand commercialization of the test in 2019," Veracyte CEO Bonnie Anderson said in a statement.

The draft policy is open to a 45-day comment period and could potentially go into effect in early 2019, according to Veracyte.

Envisia is intended for patients with interstitial lung disease who physicians suspect may have idiopathic pulmonary fibrosis, but do not have a definitive usual interstitial pneumonia pattern. Veracyte launched an early access program for the assay in May, following a clinical validation study that it published last year, and plans to launch it more broadly in 2019.