Allegro Diagnostics Corp. today announced that the AEGIS-2 clinical trial has met its primary endpoint, demonstrating that the BronchoGen™ genomic test improves the accuracy of lung cancer diagnosis when used in combination with bronchoscopy. BronchoGen is Allegro Diagnostics’ lead genomic test, and it is built upon the company’s molecular testing platform that utilizes gene expression of cytologically normal epithelial cells in the respiratory tract to aid in the diagnosis of lung cancer. Endpoints in the clinical trial include the sensitivity, specificity and negative predictive value of BronchoGen for identifying patients with malignancy. Complete results from the clinical trial will be submitted for publication in a peer-reviewed journal.
Final results of the AEGIS-1 clinical validation study have been accepted as a late-breaking abstract at the American Thoracic Society (ATS) International Conference, which is being held May 16 to 21, 2014, in San Diego. Results are consistent with preliminary data that were previously presented at the annual American College of Chest Physicians (CHEST) meeting in October 2012. The oral presentation, “Validation of a Bronchial Airway Multi-Gene Test to Improve Diagnostic Yield in Suspect Lung Cancer Cases: Results of the Prospective AEGIS-1 Trial,” will be given on May 18 by Dr. Duncan Whitney, chief scientific officer and senior vice president of research and development at Allegro Diagnostics.
“The positive results from the AEGIS trials will enable us to soon offer the BronchoGen genomic test as part of routine clinical testing for lung cancer,” said Michael D. Webb, president and chief executive officer of Allegro Diagnostics. “A large percentage of bronchoscopies currently performed result in an inconclusive cancer diagnosis, leading to costly and risky invasive diagnostic and surgical procedures. A clinical utility model using data from the AEGIS trials shows that BronchoGen could reduce the number of unnecessary invasive procedures to diagnose lung cancer by more than 40 percent.”
“We have seen promising results in the ability of BronchoGen to aid in predicting the absence of lung cancer when evaluating new lung masses, which makes this a potentially valuable test for patients and physicians,” said Gerard Silvestri, M.D., professor of pulmonary and critical care medicine at the Medical University of South Carolina, a member of Allegro Diagnostics’ clinical and scientific advisory board and a principal investigator of the AEGIS studies.
About the AEGIS Clinical Trials
The Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer (AEGIS-1 and AEGIS-2) trials were prospective, multi-center, cohort studies designed to evaluate the prediction accuracy of the BronchoGen genomic test compared to bronchoscopy alone and in combination with bronchoscopy. The AEGIS trials included 25 medical centers throughout the U.S. with more than 1,000 patients enrolled. All patients were current or former smokers undergoing bronchoscopy for suspicion of lung cancer. Endpoints included the sensitivity, specificity and negative predictive value of BronchoGen for identifying patients with malignancy.
About the Allegro Platform
Allegro Diagnostics’ molecular testing platform utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer and diseases of the airway. The “field of injury” principle on which the platform is based refers to the detectable molecular changes that occur throughout the respiratory tract in response to smoking and are correlated with disease. These changes can be detected in a gene expression signature from cytologically normal airway cells and indicate the presence of malignancy or disease processes remotely in the lung. Lung cancer tests based on sampling from the bronchus (BronchoGen™) and from the nasal passage (NasoGen™) have resulted from Allegro Diagnostics’ platform and are currently under development.