ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status
Session Title
TP26 - TP026 DIAGNOSIS, ASSESSMENT, AND PROGNOSIS OF FIBROTIC ILD
Abstract
A1839 - Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status
Author Block: L. Richeldi1, M. Scholand2, D. A. Lynch3, T. V. Colby4, J. L. Myers5, S. D. Groshong6, J. H. Chung7, D. Pankratz8, S. Walsh9, L. Lofaro9, J. Huang9, S. Bhorade9, G. Kennedy10, F. J. Martinez11, G. Raghu12, BRAVE Study Group; 1Division of Pulmonary Medicine, Fondazione Policlinico Agostino Gemelli IRCCS Università Cattolica del Sacro Cuore, Rome, Italy, 2Univ of Utah, Salt Lake City, UT, United States, 3Radiology, Natl Jewish Health, Denver, CO, United States, 4Mayo Clinic Scottsdale, Scottsdale, AZ, United States, 5Dept of Pathology, Michigan Medicine, Ann Arbor, MI, United States, 6Medicine, National Jewish Health, Denver, CO, United States, 7University of Chicago, Chicago, IL, United States, 8R&D, South San Francisco, CA, United States, 9Veracyte, Inc., San Francisco, CA, United States, 10Veracyte, Inc., South San Francisco, CA, United States, 11Weill Cornell Medical College, New York, NY, United States, 12Univ of Washington Medical Ctr, Seattle, WA, United States.
RATIONALE Idiopathic pulmonary fibrosis (IPF) is a chronic fibrosing interstitial pneumonia that has either a radiologic and/or pathologic pattern of usual interstitial pneumonia (UIP). While IPF is more common in patients >65 years, males and ever smokers, the diagnosis can be challenging especially in those younger patients, females and never smokers. The Envisia Genomic Classifier (EGC) is a clinically validated molecular test for UIP in transbronchial biopsies (TBBx) that was developed as a “rule in” test with high specificity. UIP by EGC in combination with clinical factors and HRCT findings in the context of a multidisciplinary discussion has shown clinical utility in determining an IPF diagnosis. We assessed the performance of EGC in the detection of UIP in patients who were age 65 years old, female and never smokers.
METHODS One hundred forty-four patients with complete information on gender, age and smoking status were included in this pooled, retrospective analysis of two independent validation cohorts of EGC. Patients were enrolled in the BRAVE (Bronchial Sample Collection for a Novel Genomic Test) clinical sample collection study and had undergone clinical evaluation for suspected fibrotic lung disease with standard-of-care (SOC) lung biopsies for histopathology. We compared the specificity and sensitivity of the EGC in younger ≤65 years old versus older >65 years old patients, female versus male patients and never smokers versus ever smokers.
RESULTS As previously reported, the EGC showed 90.6% [Confidence Interval (CI): 80.7, 96.5] specificity and 62.5% (CI: 51.0, 73.1) sensitivity and for histology-proven UIP pattern among 144 patients. There was no significant difference in the performance of EGC in patients ≤65 years old, female or a never smoker compared to those that were >65 years old, male or ever smokers, respectively.
CONCLUSION The EGC retains high specificity in a subset of patients (younger, female or never smokers) that are less likely to have a UIP pattern or IPF. This suggest that the EGC can provide useful diagnostic information to guide management in patients where an IPF diagnosis is less common. These results support the use of the EGC as a surrogate measure of pathologic UIP in patients whose clinical characteristics and HRCT scan are inconclusive for IPF.
Author Block: L. Richeldi1, M. Scholand2, D. A. Lynch3, T. V. Colby4, J. L. Myers5, S. D. Groshong6, J. H. Chung7, D. Pankratz8, S. Walsh9, L. Lofaro9, J. Huang9, S. Bhorade9, G. Kennedy10, F. J. Martinez11, G. Raghu12, BRAVE Study Group; 1Division of Pulmonary Medicine, Fondazione Policlinico Agostino Gemelli IRCCS Università Cattolica del Sacro Cuore, Rome, Italy, 2Univ of Utah, Salt Lake City, UT, United States, 3Radiology, Natl Jewish Health, Denver, CO, United States, 4Mayo Clinic Scottsdale, Scottsdale, AZ, United States, 5Dept of Pathology, Michigan Medicine, Ann Arbor, MI, United States, 6Medicine, National Jewish Health, Denver, CO, United States, 7University of Chicago, Chicago, IL, United States, 8R&D, South San Francisco, CA, United States, 9Veracyte, Inc., San Francisco, CA, United States, 10Veracyte, Inc., South San Francisco, CA, United States, 11Weill Cornell Medical College, New York, NY, United States, 12Univ of Washington Medical Ctr, Seattle, WA, United States.
RATIONALE Idiopathic pulmonary fibrosis (IPF) is a chronic fibrosing interstitial pneumonia that has either a radiologic and/or pathologic pattern of usual interstitial pneumonia (UIP). While IPF is more common in patients >65 years, males and ever smokers, the diagnosis can be challenging especially in those younger patients, females and never smokers. The Envisia Genomic Classifier (EGC) is a clinically validated molecular test for UIP in transbronchial biopsies (TBBx) that was developed as a “rule in” test with high specificity. UIP by EGC in combination with clinical factors and HRCT findings in the context of a multidisciplinary discussion has shown clinical utility in determining an IPF diagnosis. We assessed the performance of EGC in the detection of UIP in patients who were age 65 years old, female and never smokers.
METHODS One hundred forty-four patients with complete information on gender, age and smoking status were included in this pooled, retrospective analysis of two independent validation cohorts of EGC. Patients were enrolled in the BRAVE (Bronchial Sample Collection for a Novel Genomic Test) clinical sample collection study and had undergone clinical evaluation for suspected fibrotic lung disease with standard-of-care (SOC) lung biopsies for histopathology. We compared the specificity and sensitivity of the EGC in younger ≤65 years old versus older >65 years old patients, female versus male patients and never smokers versus ever smokers.
RESULTS As previously reported, the EGC showed 90.6% [Confidence Interval (CI): 80.7, 96.5] specificity and 62.5% (CI: 51.0, 73.1) sensitivity and for histology-proven UIP pattern among 144 patients. There was no significant difference in the performance of EGC in patients ≤65 years old, female or a never smoker compared to those that were >65 years old, male or ever smokers, respectively.
CONCLUSION The EGC retains high specificity in a subset of patients (younger, female or never smokers) that are less likely to have a UIP pattern or IPF. This suggest that the EGC can provide useful diagnostic information to guide management in patients where an IPF diagnosis is less common. These results support the use of the EGC as a surrogate measure of pathologic UIP in patients whose clinical characteristics and HRCT scan are inconclusive for IPF.
