Allegro Diagnostics has completed patient enrolment in the 1,320-patient Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer II (AEGIS II) trial, designed to evaluate the BronchoGen genomic test as a treatment for lung cancer.
Built upon the company’s molecular testing platform, BronchoGen utilises gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer.
The multicentre, prospective AEGIS II trial is designed to demonstrate the diagnostic ability of the BronchoGen genomic test used in conjunction with bronchoscopy to detect early signs of lung cancer in current or former cigarette smokers.
The study’s endpoints include the sensitivity, specificity, negative predictive value and positive predictive value of BronchoGen for identifying patients with malignancy.
Michael Webb, Allegro Diagnostics president and chief executive officer, said the company is now evaluating BronchoGen in more than 2,000 patients and in the process have generated the prospective clinical dataset for a lung cancer molecular diagnostic.
"This trial significantly advances our product development strategy for the BronchoGen genomic test, which is rapidly approaching commercialisation," Webb added.
"More than half of the more than 300,000 bronchoscopies performed annually in the United States in patients at high risk for lung cancer result in an inconclusive cancer diagnosis.
"We believe that BronchoGen has the potential to improve dramatically upon the current diagnostic standard of care."
Duncan Whitney, Allegro Diagnostics technical operations and research, development senior vice president and study director, said: "While results from AEGIS II are expected in 2013, later this year we will announce data from the 730-patient AEGIS I trial, which was designed to demonstrate the diagnostic accuracy of BronchoGen and serve as the basis to make this potentially valuable test available to patients and clinicians."