Allegro Diagnostics, a molecular diagnostic company, has reported positive results from its airway epithelium gene expression in the diagnosis of lung cancer (Aegis I) trial, designed to demonstrate the prediction accuracy of its lung cancer detection assay.
The BronchoGen genomic test uses the company’s PCR molecular testing platform that utilises a genomic signature of normal epithelial cells in the respiratory tract to detect early signs of lung cancer in current and former smokers.
The case-controlled, multi-centre, prospective study 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.
To identify genes associated with lung cancer, microarray analysis was performed and a prediction model was developed and validated using independent training (220 samples) and test sets (110 samples), according to the company.
Allegro Diagnostics clinical and scientific advisory board member and study principal investigator Dr Gerard Silvestri said the results show significantly higher sensitivity and negative predictive value in lung cancer diagnoses with 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 said.
Allegro Diagnostics research, development and technical operations senior vice president and study director Dr Duncan Whitney said over 300,000 bronchoscopies are performed in the US every year in patients at high risk for lung cancer, and as many as half result in an inconclusive cancer diagnosis.
"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 said.
"We are currently planning to commercialize BronchoGen for use with bronchoscopy in 2013."
Complete results from the AEGIS I trial are expected to be released later in 2012.