Clinical trial results show that combining the Allegro Diagnostics BronchoGen genomic test and standard bronchoscopy improves lung cancer diagnoses, the company announced
during a conference presentation. Allegro presented the results of its AEGIS I trial October 23 at the 78th annual meeting of the American College of Chest Physicians in Atlanta. Based on the company’s molecular testing platform, BronchoGen uses gene expression of normal epithelial cells in the respiratory tract to help diagnose lung cancer, the company says.
The AEGIS I is a case-controlled, multicenter trial involving 730 patients who are current or former smokers undergoing bronchoscopy for possible lung cancer, Allegro says. A second trial, the AEGIS II, has an enrollment of more than 1300 patients. The trial results are based on an analysis of data from 240 patients with confirmed cancers and 90 control subjects, according to Allegro. The tests measure BronchoGen’s sensitivity, specificity, negative predictive value, and positive predictive value for identifying patients with malignancy, the company says.
Allegro says it expects to release complete results from the AEGIS I trial by the end of 2012. Clinical validation of BronchoGen is also expected this year, says the Massachusetts-based company, which has plans to commercialize the technology in 2013.