Envisia Genomic Classifier Highlighted in Updated Clinical Practice Guideline Regarding Idiopathic Pulmonary Fibrosis Diagnosis

Review article and commentary in AnnalsATS reinforce clinical utility of genomic test to improve confidence in IPF diagnosis, in conjunction with HRCT and clinical factors

Veracyte, Inc. announced  that an updated clinical practice guideline highlights the role of the Envisia Genomic Classifier in the diagnosis of idiopathic pulmonary fibrosis (IPF). The document, Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline, appears online in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). Additionally, a new review article and separate commentary on the Envisia Genomic Classifier appear online in AnnalsATS. AJRCCM and AnnalsATS are official journals of the American Thoracic Society.

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“We are encouraged by the extensive discussion of the Envisia Genomic Classifier in this updated guideline and the related articles regarding diagnosis of IPF and other interstitial lung diseases,” said Giulia C. Kennedy, Ph.D., Veracyte’s global chief scientific officer and chief medical officer. “We believe these discussions reinforce the intended clinical value of our test, which is to enable physicians to make a confident diagnosis of IPF, without the need for invasive surgery.”

The Envisia classifier detects a genomic pattern of usual interstitial pneumonia (UIP), a critical factor that can help physicians differentiate IPF from other interstitial lung diseases (ILDs), without the need for surgery. The test was developed using RNA whole-transcriptome sequencing and machine learning and is covered by Medicare.

“IPF and other ILDs are often extremely challenging to diagnose,” said Fayez Kheir, M.D., a pulmonologist at Massachusetts General Hospital and lead author of the review article. “The Envisia test, with its ability to help rule in UIP, may help give physicians more confidence in an IPF diagnosis, when used in conjunction with HRCT and clinical factors. Having a confident IPF diagnosis is important because it can help these patients to obtain the therapy they need in a timely manner.”

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More than 40 percent of the guideline authors voted to specifically recommend genomic classifier testing for use in clinical practice. According to the guideline, “Those who favored genomic classifier testing believed that the high specificity provided important diagnostic information that can be used in MDD [multi-disciplinary discussion] and, therefore, may reduce the need for additional sampling for histopathology diagnosis.”

The guideline points to a meta-analysis of data for the Envisia test, which showed a specificity for identifying a UIP pattern of 92 percent and a sensitivity of 68 percent in patients with an ILD of unknown type following clinical evaluation and high-resolution computed tomography (HRCT).

Approximately 200,000 patients are evaluated for suspected ILDs each year in the United States and Europe. ILDs are serious, lung-scarring diseases that are often difficult to diagnose; IPF is among the most common and dangerous of these illnesses. In a U.S. survey of people with ILDs including IPF, 55 percent of patients reported at least one misdiagnosis prior to receiving an accurate diagnosis and more than a third (38 percent) reported at least two misdiagnoses. This diagnostic challenge often leads to treatment delays, misdiagnoses, patient distress, and added healthcare expense. Accurate and timely diagnosis of IPF is especially important given the availability of drugs to slow progression of the disease.

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