Veracyte Announces Publication of Study Showing Robust Performance of Percepta GSC in Improving Lung Cancer Diagnosis
Veracyte, Inc. (Nasdaq: VCYT) announced today the publication of a new study that demonstrates the robust performance of the Percepta Genomic Sequencing Classifier (GSC), a novel genomic test, in helping to improve lung cancer diagnosis. The data, based on widely accepted community guidelines for establishing analytical validity, add to the growing body of clinical evidence supporting the use of the Percepta GSC to guide next steps for patients with lung nodules whose bronchoscopy results are inconclusive. The peer-reviewed paper appears online in the journal BMC Cancer.
Veracyte scientists followed criteria established by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group and the Centers for Disease Control’s ACCE Project to evaluate the analytical validity of the Percepta GSC. They also assessed the Percepta GSC for reproducibility within and across laboratories.
Based on the guidelines, the scientists determined the Percepta GSC test is suitable for routine clinical use with robust analytical sensitivity, analytical specificity, and reproducibility. Expected variability in clinical laboratories — assessed in this study by using different instruments, operators, and labs — was found to be negligible.
“We are pleased to share the results of this analytical validation study, which clearly demonstrate the Percepta GSC’s robust performance regardless of variations in RNA quantity, as well as the presence of blood or other contaminants, in patient samples,” said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer, and an author of the study. “These findings should give physicians further confidence that the Percepta GSC can help them determine next steps for their lung-nodule patients when bronchoscopy results are inconclusive.”
About the Percepta GSC
The Percepta GSC is an RNA sequencing-based risk-stratification test designed to aid patient management in cases where a lung nodule is present and bronchoscopy results are unclear. Veracyte estimates that approximately 545,000 bronchoscopies are performed each year to evaluate suspicious lung nodules and that up to 60 percent of these produce inconclusive results. The Percepta GSC is based on novel “field of injury” science, which identifies genomic changes that correlate with lung cancer risk in current or former smokers using a brushing to collect cells from the patient’s main lung airway during a standard bronchoscopy, without the need to sample the lesion directly. Previous analyses demonstrated the test’s accuracy in “down-classifying” patients at low risk of lung cancer and in “up-classifying” patients at high risk of the disease.1 The test has been commercially available since June 2019.