Veracyte Announces Clinical Utility Study Published in CHEST Demonstrates Envisia Genomic Classifier’s Ability to Improve IPF Diagnosis
The Envisia classifier is the first and only commercially available genomic test that helps distinguish IPF from other interstitial lung diseases (ILDs), without the need for risky surgery.
The new study compared the impact of Envisia classifier results on diagnostic decision-making among two physician multidisciplinary discussion (MDD) groups that each evaluated 24 patients with suspected IPF or other ILDs whose HRCT results were inconclusive. The groups sequentially reviewed clinical and HRCT findings, followed by Envisia results, either after (MDD1) or before (MDD2) findings from cryobiopsy (a diagnostic procedure that is sometimes conducted during bronchoscopy). In each case, the MDD group sought additional information, including UIP, to make a more confident ILD diagnosis, including IPF in some cases.
The researchers found that the rate of high-confidence diagnosis was significantly higher for the MDD1 group after adding the Envisia results to those of cryobiopsy (46% to 75%). The increase in a confident diagnosis was higher for those individuals with “probable” UIP (43% to 93%) and patients with a final diagnosis of IPF (31% to 92%). Additionally, they found high overall agreement between the Envisia result and the final diagnosis of UIP or non-UIP for both MDD groups (96% and 92%, for MDD1 and MDD2 respectively) as compared to 83% agreement between cryobiopsy results and both MDD groups.
“Distinguishing IPF from other ILDs can be challenging even in settings where a multidisciplinary approach is used. However, obtaining a timely, accurate diagnosis is critical to rapidly initiate and optimize treatments to slow disease progression,” said
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“This new publication adds to the growing body of clinical evidence showing that the Envisia classifier helps physicians make a more confident diagnosis of IPF,” said
The Envisia Genomic Classifier is the first commercially available test to improve the diagnosis of idiopathic pulmonary fibrosis (IPF). The genomic test enables physicians to more confidently differentiate IPF from other interstitial lung diseases (ILDs), helping to guide an optimal patient treatment plan that can improve outcomes and reduce risk. The Envisia classifier was developed using RNA whole-transcriptome sequencing and machine learning to identify the usual interstitial pneumonia (UIP) pattern, which is a hallmark of IPF. The test assesses patient samples obtained through bronchoscopy, a nonsurgical procedure commonly used in lung evaluation, and is used as a complement to high-resolution computed tomography (HRCT). 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.
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This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the Envisia classifier’s ability to diagnose IPF. Forward-looking statements are neither historical facts nor assurances of future performance, but are based only on our current beliefs, expectations and assumptions. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: the impact of COVID-19 on Veracyte’s business and operating results, specifically, and the healthcare system and economy more generally, Veracyte’s ability to achieve and maintain Medicare coverage for its tests; the benefits of Veracyte’s tests and the applicability of clinical results to actual outcomes; the laws and regulations applicable to Veracyte’s business, including potential regulation by the
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