Allegro Diagnostics has presented positive results from a clinical trial of its BronchoGen genomic test, designed for the early detection of lung cancer in current and former smokers.
Using the company’s PCR molecular testing platform which utilizes a genomic signature of normal epithelial cells in the respiratory tract, the assay diagnose the patients who are at high risk of lung cancer.
The case-controlled, multi-center, prospective trial, Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer (AEGIS I ), has enrolled 730 patients to compare the safety and efficacy of the genomic test in combination with bronchoscopy.
Endpoints for the BronchoGen trial include sensitivity, specificity, negative predictive and positive predictive values.
Allegro Diagnostics clinical and scientific advisory board member and study principal investigator Gerard Silvestri said the positive results show significantly higher sensitivity and negative predictive value in lung cancer diagnoses using BronchoGen in combination with bronchoscopy than by bronchoscopy alone.
"The data suggest that BronchoGen has the ability to aid bronchoscopy in better predicting the presence or absence of cancer, possibly avoiding costly and risky invasive procedures," Silvestri added.
Allegro Diagnostics research, development and technical operations senior vice president and study director Dr. Duncan Whitney said the company is currently planning to commercialize BronchoGen for use with bronchoscopy in 2013.
"Allegro Diagnostics has one of the biggest and most robust development programs for lung cancer diagnosis, as our ongoing AEGIS II clinical trial has enrolled 1,320 patients, bringing the total enrollment to over 2,000," Whitney added.
The company said complete results from the AEGIS I trial are expected to be released later in 2012.