Therapy Areas: Respiratory
Veracyte Expands Envisia Genomic Classifier Early Access Programme
7 December 2018 - - Twenty medical centres across the United States are now offering the Envisia Genomic Classifier through an Early Access Program to patients who are undergoing evaluation for interstitial lung diseases, including idiopathic pulmonary fibrosis, US-based genomic diagnostics company Veracyte, Inc. (NASDAQ: VCYT) said.

The programme, launched in May 2018, provides advance access to the Envisia classifier, which the company anticipates making available nationwide in 2019.

The Envisia Genomic Classifier was developed using the company's RNA whole-transcriptome sequencing and machine learning technology to improve physicians' ability to differentiate IPF from other ILDs without the need for surgery.

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 + Thomas Jefferson University), Keck Medicine of USC, Providence Sacred Heart Medical Center in Washington state and University of California, Los Angeles, and others whose participation was previously announced. Patients can now access the Envisia classifier in 12 states across the country.

A recently published survey conducted 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, accurate 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 190-gene Envisia classifier detects the genomic pattern of usual interstitial pneumonia, a hallmark of IPF, with high accuracy (88% specificity and 70% 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 through the MolDX program for its Envisia classifier and anticipates that the policy will become final in early 2019.

Each year in the United States and Europe, up to 200,000 patients are evaluated for suspected interstitial lung disease, including IPF, which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases.

Physicians routinely use high-resolution computed tomography 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.

Veracyte said the Envisia Genomic Classifier is the first commercially available test to improve the diagnosis of idiopathic pulmonary fibrosis.

The Envisia classifier enables physicians to more confidently differentiate IPF from other interstitial lung diseases, helping to guide an optimal patient treatment plan that can improve outcomes and reduce risk. The classifier works by harnessing the power of RNA sequencing and machine learning to detect a genomic pattern of usual interstitial pneumonia, whose presence is required for IPF diagnosis.

The Envisia classifier is proven to detect UIP with high correlation to the gold standard histopathology results read by ILD experts without the need for surgery.

The company's products combine advanced genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward, informing both diagnosis and treatment decisions without the need for costly, risky surgeries that are often unnecessary. 

Since its founding in 2008, Veracyte has commercialised three genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis and collectively target a USD 2bn market opportunity. Veracyte is based in South San Francisco, California.
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