Veracyte Inc has launched an Early Access Program to begin making the Envisia Genomic Classifier available to patients being evaluated for interstitial lung diseases (ILD), including idiopathic pulmonary fibrosis (IPF).
Physicians from Jefferson (Philadelphia University and Thomas Jefferson University), Keck Medicine of USC, Providence Sacred Heart Medical Center in Washington state and University of California, Los Angeles (UCLA) are among the first to participate in the program, offering patients the new genomic test to enable more confident IPF diagnoses and help ensure optimal treatment, without the need for surgery.
“Obtaining an accurate, timely IPF diagnosis is important given the availability of new drugs that can slow the progression of this debilitating disease, as well as the need to avoid inappropriate and potentially harmful treatment,” said S. Samuel Weigt, MD, MS, associate professor of medicine at UCLA and director of UCLA Health’s Interstitial Lung Disease Center. “Unfortunately, IPF is often difficult to distinguish from other ILDs, even with the most advanced imaging technologies. Further, diagnostic surgery is risky, expensive and may not be viable for some patients. We are pleased to be one of the few medical facilities in the country to have access to this breakthrough technology.”
A recently published study by the Pulmonary Fibrosis Foundation found that more than half of patients with IPF or other ILDs were misdiagnosed at least once and that, for four in 10 ILD patients, diagnosis took more than a year. Among those patients with IPF, more than one in five reported treatment during the diagnostic process with systemic corticosteroids, a potentially harmful therapy for IPF patients.
The Envisia Genomic Classifier combines RNA sequencing and machine learning to improve physicians’ ability to differentiate IPF from other ILDs through patient samples that are obtained through transbronchial biopsy, a nonsurgical procedure that is commonly used in lung evaluation. The 190-gene test detects the genomic pattern of usual interstitial pneumonia (UIP), a hallmark of IPF, with high accuracy (88 percent specificity and 70 percent sensitivity).
“Multiple studies have demonstrated that the Envisia Genomic Classifier supports more confident IPF diagnosis and optimal patient management,” said Bonnie Anderson, chairman and chief executive officer of Veracyte. “We are honored to be working with physicians at leading institutions as we begin making the test available to help ease what is often a challenging diagnostic journey for patients with IPF or other ILDs. Our Early Access Program – while limited to a small number of institutions – will enable us to begin providing access to the test in advance of its anticipated, nationwide commercial expansion in 2019.”