The coverage determination was issued through the Palmetto GBA MolDx (Molecular Diagnostics) service program, and will be effective April 1.
The Envisia classifier is a genetic test to help doctors distinguish IPF from other interstitial lung diseases (ILD), without the need for invasive procedures such as surgery.
Every year in the U.S. and Europe, up to 200,000 patients are suspected of having an ILD. As the symptoms of IPF are similar to those of other lung diseases, an accurate diagnosis can be difficult.
A timely IPF diagnosis is important, as treatment varies widely from other types of ILDs, and recent data showed that conventional therapies for most ILDs, such as systemic cortisol, can be harmful to people with IPF.
To identify IPF, doctors routinely evaluate a patient’s medical history along with lung imaging scans (e.g. chest X-ray and high-resolution computed tomography, or HRCT), lung function tests (e.g. spirometry, pulse oximetry, exercise test, and arterial blood gas test), along with lung fluid and tissue analysis (e.g. bronchoscopy). But this approach can be inconclusive, and lead to more invasive exams such as a surgical biopsy.
The Envisia Genomic Classifier test uses patient 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 the activity levels of genes — and machine learning, Envisia allows the detection of UIP with high accuracy, compared with HRCT — a gold-standard tool to evaluate IPF. Envisia’s sensitivity for spotting UIP is 70 percent, compared to 43 percent for HRCT.
The new test is meant to be used as a complement to HRCT, providing clinicians with a more confident IPF diagnosis.
“A common theme in my conversations with other IPF patients is that we faced significant challenges in obtaining an accurate diagnosis,” Bill Vick, IPF patient and founder of the advocacy group PF Warriors, said in Veracyte’s news release. “A tool that can provide more clarity in this diagnosis will alleviate anxiety for patients and, importantly, enable them to get appropriate treatment faster so that they have the potential to live longer, fuller, more productive lives.”
In May 2018, Veracyte launched an Early Access Program to make the Envisia test available for IPF patients across the U.S. In August, the test gained a draft Medicare local coverage determination, now fully authorized.
“This important milestone will enable us to begin making the Envisia Classifier more widely available to patients with suspected IPF so that they can obtain an accurate, timely diagnosis and, in turn, appropriate treatment,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer.
The Envisia classifier is the first test for enhancing IPF diagnosis to be commercialized, and Veracyte’s third genomic test to gain Medicare coverage since the company’s founding in 2008. The others were Afirma for thyroid cancer (2012), and Percepta for lung cancer (2016).