The New York State Department of Health has authorized the use of Veracyte‘s Envisia Genomic Classifier, the first commercially available test to help distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILD), without the need for risky surgery.
Authorization takes effect immediately, making the Envisia classifier available as of now to doctors and patients in New York. The test was granted full Medicare coverage in the U.S. in March.
“We are pleased that the Envisia classifier will now be available to physicians and their patients in New York State,” Bonnie Anderson, Veracyte’s chairman and CEO, said in a press release.
“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,” she added.
The Envisia classifier will be used as a complement to high-resolution computed tomography, or HRCT — a gold-standard diagnostic tool to evaluate IPF. The test will help doctors make more confident diagnoses of IPF without the need for a surgical lung biopsy, which can be particularly helpful in cases where HRCT provides inconclusive results or patients are too fragile to undergo surgery.
A recent study demonstrated the test had a high sensitivity, minimized false positive identifications, and agreed with biopsy findings in 86% of the cases, supporting its clinical value.
Envisia uses samples obtained via transbronchial biopsy — a nonsurgical procedure in which a bronchoscope is inserted through the nose or mouth to collect samples of lung tissue. Using a detection panel for 190 genes, the classifier identifies the genomic pattern of usual interstitial pneumonia (UIP), an altered pattern of lung structure characteristic of IPF.
Combining RNA sequencing — a sensitive technique that measures gene activity — and machine learning, Envisia allows the detection of UIP with high accuracy.
According to Veracyte, every year in the U.S. and Europe, up to 200,000 patients are suspected of having an ILD, including IPF. Because the symptoms of IPF are similar to those of other lung diseases, an accurate diagnosis can be difficult.
In fact, according to a study by the Pulmonary Fibrosis Foundation, about half of IPF/ILD patients report being misdiagnosed at least once, and 1 in 5 patients have to wait three or more years to be correctly diagnosed.
A timely and accurate diagnosis is crucial so that IPF patients can be offered adequate therapies that may slow disease progression, while avoiding inappropriate and potentially harmful treatments.
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