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Veracyte Announces Clinical Utility Study Published in CHEST Demonstrates Envisia Genomic Classifier’s Ability to Improve IPF Diagnosis
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced today the publication of an independent study showing that the Envisia
About this update from Veracyte, Inc.
[{"type":"text","content":" SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVeracyte, Inc. (Nasdaq: VCYT) announced today the publication of an independent study showing that the Envisia Genomic Classifier enables physicians to more confidently diagnose idiopathic pulmonary fibrosis (IPF), a progressive lung disease, when results from high-resolution CT (HRCT) imaging are not definitive. The real-world clinical findings appear online ahead of print in CHEST, the journal of the American College of Chest Physicians.\n\n\nThe 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. Veracyte developed the classifier by combining RNA whole-transcriptome sequencing and machine learning, which enables a comprehensive genomic approach for distinguishing the usual interstitial pneumonia (UIP) pattern, whose presence is essential to IPF diagnosis. Veracyte is preparing to launch the test in global markets in 2021.\n\n\nThe 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.\n\n\nThe 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.\n\n\n“Distinguishing IPF from other ILDs can be challenging even in settings where a multidisciplinary approach ...