Allegro Diagnostics: Allegro says BronchoGen improves lung cancer diagnosis

Allegro Diagnostics Inc. (Maynard, Mass.) said its BronchoGen genomic test used in conjunction with bronchoscopy met the primary endpoint of improved accuracy of lung cancer diagnosis vs. bronchoscopy alone in the pivotal AEGIS II trial. The trial enrolled 1,331 current or former cigarette smokers undergoing bronchoscopy for suspicion of lung cancer. Allegro also said a clinical utility model using data from the pivotal AEGIS I and AEGIS II trials showed that BronchoGen could reduce the number of unnecessary invasive procedures to diagnose lung cancer by more than 40%. In 2012, Allegro said BronchoGen alone had 77% sensitivity and 73% specificity for identifying lung cancer in AEGIS I, which enrolled 330 current or former cigarette smokers undergoing bronchoscopy for suspicion of lung cancer.Allegro said BronchoGen will be available through the company's CLIA-certified laboratory in the U.S. for use as part of routine clinical testing for lung cancer, but declined to disclose a time frame for the test's availability. BronchoGen uses normal epithelium gene expression in the respiratory tract to diagnose lung cancer.