Veracyte Receives Regulatory Authorization to Offer Envisia Genomic Classifier for Patients in New York State

Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, announced today that it has received regulatory authorization from the New York State Department of Health to offer the Envisia Genomic Classifier for patients in the state effective immediately. The genomic test is the first commercially available test to help distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILD), without the need for risky surgery.

“We are pleased that the Envisia classifier will now be available to physicians and their patients in New York State,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “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.”

Over 100,000 people in the United States have lung-scarring ILDs, including IPF, which is the deadliest type, and the number is rising. While therapies are now available to slow progression of this deadly disease, 55 percent of IPF/ILD patients reported being misdiagnosed at least once and, for one in five patients, accurate diagnosis took three or more years, according to a study by the Pulmonary Fibrosis Foundation.

Earlier this month, clinical validation and clinical utility data for the Envisia classifier were published in The Lancet Respiratory Medicine, demonstrating the test’s ability to identify the telltale pattern of IPF, while minimizing false positive results, and its usefulness in giving physicians more confidence in their diagnosis of patients being evaluated for interstitial lung disease, including IPF, without the need for surgery.

The Envisia classifier is used as a complement to high-resolution computed tomography (HRCT).

About Interstitial Lung Disease

Each year in the United States and Europe, up to 200,000 patients are evaluated for suspected interstitial lung disease, including idiopathic pulmonary fibrosis, which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases. Physicians routinely use high-resolution computed tomography (HRCT) along with a clinical work-up to help identify IPF, but this approach frequently provides inconclusive results, leading many patients to undergo invasive and potentially risky surgery for a more definitive diagnosis. Other patients are too frail to undergo surgery and may never receive an accurate diagnosis, which can result in suboptimal – and potentially harmful – treatment.