Allegro Diagnostics has completed patient enrollment in 1,320-patient Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer II (AEGIS II) trial for BronchoGen genomic test.
BronchoGen, which is built on the company’s molecular testing platform, uses gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer.
The multi-center, 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.
Allegro Diagnostics president and chief executive officer Michael Webb said the company is now evaluating BronchoGen in over 2,000 patients and in the process have generated the prospective clinical dataset for a lung cancer molecular diagnostic.
"We believe that BronchoGen has the potential to improve dramatically upon the current diagnostic standard of care," Webb added.
Allegro Diagnostics technical operations and research, development senior vice president and study director Duncan Whitney 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."