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Veracyte Expands Early Access for Genomic Lung Disease Classifier

NEW YORK (GenomeWeb) – Veracyte said yesterday that it has expanded the early-access program (EAP) for its Envisia Genomic Classifier for differentiating idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILDs).

Veracyte launched the EAP in May to provide advance access to the test in anticipation of a nationwide launch in 2019.

Physicians from Banner-University Medical Center Tucson, Cleveland Clinic, Cooper University Health Care, Penn Highlands Healthcare, Tulane University School of Medicine, and University Hospitals Cleveland Medical Center are among the most recent to participate in the Envisia EAP.

They join Jefferson (Philadelphia University and Thomas Jefferson University); Keck Medicine of the University of Southern California; Providence Sacred Heart Medical Center in Washington state; the University of California, Los Angeles; and others. Veracyte said that 20 medical centers in the US are now offering the test through the EAP.

The 190-gene Envisia classifier combines RNA whole-transcriptome sequencing and machine learning to detect the genomic pattern of usual interstitial pneumonia, a hallmark of IPF, with 88 percent specificity and 70 percent sensitivity. The genomic test is performed on patient samples obtained through transbronchial biopsy, a nonsurgical procedure that is commonly used in lung evaluation. Veracyte recently received a draft Medicare local coverage decision for Envisia through the MolDX program and anticipates that the policy will become final in early 2019.

"Accurate and timely diagnosis of IPF and other ILDs is often a major challenge for physicians and patients, even with the most advanced imaging technologies," Joseph Lasky of Tulane University School of Medicine said in a statement. "A precise diagnosis is fundamental for developing an optimal patient treatment plan. This may include the use of antifibrotic therapies that are now available to slow progression of IPF, as well as the avoidance of potentially harmful treatments. We are delighted to be one of the first medical centers in the United States to offer this breakthrough genomic technology to our patients."