NEW YORK (GenomeWeb) — Veracyte and a team of academic collaborators reported yesterday clinical data showing that the company's microarray-based Percepta Bronchial Genomic Classifier, which uses a 23-gene panel to identify patients at low risk of cancer following an inconclusive bronchoscopy result, may help prevent unnecessary invasive procedures.
"As the number of lung nodules and lesions are increasing due to both incidental findings and expanding lung cancer screening programs, providers need clinically proven tools to help them more confidently determine which patients can be followed with CT scans and avoid additional, invasive and potentially risky tests," Anil Vachani, a University of Pennsylvania researcher and lead author of the research, said in a statement. "Our findings suggest that use of the Percepta classifier may help reduce the frequency and associated morbidity of invasive procedures in lung cancer diagnosis."
The findings, which appeared in Chest, were based on data from two prospective, multicenter studies designed to evaluate the prediction accuracy of an earlier version of Percepta alone and in combination with bronchoscopy, compared with just bronchoscopy.
The studies enrolled 939 current and former smokers undergoing bronchoscopy for suspected lung cancer, and 188 of these patients were determined to have a low and intermediate probability of cancer following an inconclusive results and had follow-up data available for further analysis. The researchers used the Percepta test to evaluate samples from the 77 of these patients who underwent additional invasive procedures including surgical lung biopsy and transthoracic needle biopsy. Of these 77 patients, 42 were ultimately diagnosed with benign disease.
"Among those undergoing surgical biopsy, 20 were performed in patients with benign disease," the researchers wrote in Chest. "Were the classifier used to guide decision making, procedures could have been avoided in 50 percent of patients undergoing further invasive testing. Further, among 35 patients with an inconclusive index bronchoscopy that were diagnosed with lung cancer, the sensitivity of the classifier was 89 percent, with four patients having a falsely negative classifier result."
The conclusions assume that a negative classifier result would result in a decision to use surveillance imaging instead of proceeding to an additional invasive procedure. The investigators cautioned in their paper that their study was not designed to assess the factors associated with decisions to pursue additional invasive procedures and that, because the study was blinded, they were not able to directly evaluate the actual impact of that classifier on their decision-making.
Additionally, the researchers noted that they were unable to evaluate whether some of the invasive procedures in patients with benign disease "resulted in a diagnosis that altered clinical management of that patient, providing clinically useful results to the physician."
Overall, however, the analysis suggests that Percepta during bronchoscopy may reduce invasive procedures, the study's authors concluded.
The Chest paper follow the mid-2015 publication of data demonstrating the validity of Percepta's biomarker panel and its efficacy in averting potentially risky lung biopsies.
Percepta was launched in April 2015 and last month received clearance from the New York State Department of Health.