Veracyte Expands Early Access to Envisia Genomic Classifier Test for IPF Diagnosis

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by Santiago Gisler |

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Envisia Genomic Classifier test

Veracyte recently announced the expansion of an early access program offering the Envisia Genomic Classifier test for the diagnosis of idiopathic pulmonary fibrosis (IPF).

In the U.S., 20 medical centers in 12 states are now offering the Envisia Genomic test through the program, and the company expects it to be available to patients nationwide in 2019.

The Envisia Genomic Classifier is a procedure that can differentiate between IPF and other interstitial lung diseases (ILDs) by comparing genomic patterns in patient samples. The approach may help improve a physician’s ability to detect IPF without surgery, the company says.

“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 A. Lasky, MD, of the Tulane University School of Medicine, said in a press release.

“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,” Lasky said.

A recent U.S.-based survey conducted by the Pulmonary Fibrosis Foundation found that patients with IPF or other ILDs often experience misdiagnosis, delays, and expensive and invasive procedures. It found that more than half (55%) of patients with IPF or other ILDs had been misdiagnosed at least once.

According to the survey, misdiagnosis can lead to patients receiving late treatments and/or treatment that may be unspecific or unresponsive for IPF. For example, the survey showed that 1 in 5 patients had been prescribed systemic cortisol, a treatment that is discouraged by international guidelines due to its potential harmful side effects in IPF patients.

“For many patients with IPF or other ILDs, the emotional toll of learning they have a serious lung disease is often compounded by the challenges they experienced in getting a diagnosis,” said Sandeep Bansal, MD, medical director for Penn Highlands Healthcare Lung Center in DuBois, Pennsylvania. “Data suggest that the Envisia Genomic Classifier can help us reduce this burden and significantly improve care for these patients.”

The Envisia Genomic Classifier analyzes genomic material from patient samples obtained through a bronchoscopy, a nonsurgical procedure. The genomic test can, with high specificity (88%) and sensitivity (70%), detect known patterns that are common in usual interstitial pneumonia, a pattern required for IPF diagnosis.

“As a complement to high-resolution CT [computed tomography] imaging, the Envisia classifier can improve patient care by enabling physicians to more confidently differentiate IPF from other ILDs. This may help patients get appropriate treatment sooner, without the need for risky surgery or other diagnostic procedures,” said Bonnie Anderson, Veracyte’s chairman and CEO.

Veracyte launched the early access program in May. Recently, the Envisia Genomic Classifier received a draft Medicare local coverage determination through the Molecular Diagnostics (MolDx) service program, a key step in making the test widely available to patients.

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