-- Data Obtained Using PCR Platform Predict Successful Clinical Validation by End of 2012 --
-- Ongoing AEGIS II Clinical Trial Brings Total Program Enrollment to More Than 2,000 Patients --
Allegro Diagnostics Presents Positive AEGIS I Trial Results of BronchoGen™ Genomic Test to Improve Diagnosis of Lung Cancer at Annual CHEST Meeting
<0> MacDougall Biomedical CommunicationsDoug MacDougall or Charles Liles, 781-235-3060 </0>
today presented positive results from the AEGIS I (irway pithelium ene Expression n the Diagnosi of Lung Cancer) clinical trial, which demonstrate the diagnostic accuracy of the BronchoGen™ genomic test 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. Duncan Whitney, Ph.D., Senior Vice President, Research, Development and Technical Operations of Allegro Diagnostics and the study’s director, presented the results, “Bronchial Airway Gene-expression Testing Improves the Diagnostic Yield of Bronchoscopy for Lung Cancer: Results of the AEGIS Trial,” during a late-breaking abstract session at the (CHEST). CHEST is being held at the Georgia World Congress Center in Atlanta, October 20-25, 2012. The abstract will also appear in a supplement to the October 2012 issue of .
“These positive results show significantly higher sensitivity and negative predictive value in lung cancer diagnoses using BronchoGen in combination with bronchoscopy than by bronchoscopy alone,” 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 & Scientific Advisory Board and a principal investigator of the AEGIS studies. “The data suggest that BronchoGen has the ability to aid bronchoscopy in better predicting the presence or absence of cancer, possibly avoiding costly and risky invasive procedures.”
“Allegro Diagnostics has one of the biggest and most robust development programs for lung cancer diagnosis, as our ongoing AEGIS II clinical trial has enrolled 1,320 patients, bringing the total enrollment to over 2,000,” said Dr. Whitney. “Over 300,000 bronchoscopies are performed annually in the United States in patients at high risk for lung cancer, and as many as half result in an inconclusive cancer diagnosis. We are currently planning to commercialize BronchoGen for use with bronchoscopy in 2013.”
The Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer (AEGIS I) trial is a prospective, case-controlled, multi-center study designed to evaluate the prediction accuracy of the BronchoGen™ genomic test compared to and in combination with bronchoscopy. The AEGIS trials have included 25 medical centers throughout the United States with 730 patients enrolled in AEGIS I and over 1300 in AEGIS II. All patients are current or former smokers undergoing bronchoscopy for suspicion of lung cancer. Endpoints include the sensitivity, specificity, negative predictive value and positive predictive value of BronchoGen for identifying patients with malignancy.
Data was analyzed from a total of 330 patient samples—240 patients with confirmed cancers and 90 controls. Microarray analysis was performed to identify genes associated with lung cancer, and a prediction model was developed and validated using independent training (220 samples) and test sets (110 samples). The test was converted to a reverse transcriptase polymerase chain reaction (RT-PCR) platform to validate the genes discovered on microarrays, as well as to optimize performance for commercial testing. Characterization of the test was based on re-analyzing a subset (N=217) of the patient samples.
Allegro reported that the PCR-based test yielded a sensitivity of 77% (95% confidence interval (C.I.), 71-83%) and specificity of 73% (95% C.I., 67-79%). When combining the gene test with results from bronchoscopy it was reported the sensitivity of detecting lung cancer is 94% (95% C.I., 91-97%), compared to a sensitivity of only 74% for bronchoscopy alone. Further, the negative predictive value (NPV) of the combined test was 0.85 (95% C.I., 0.80-0.90), compared to an NPV of 0.65 (95% C.I., 0.59-0.71) for bronchoscopy alone. This 20 percentage-point increase in NPV is expected to provide a much-needed improvement in clinical practice.
Complete results from the AEGIS I trial and clinical validation of BronchoGen are expected to be released later in 2012.
Allegro Diagnostics’ molecular testing platform utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer. The “field of injury” principle on which the platform is based refers to the common molecular response that occurs throughout the respiratory tract in current and former smokers with lung cancer. These changes can be detected in a gene expression signature from non-malignant airway cells and indicate the presence of malignancy remotely in the lung. Allegro has applied this platform to generate multiple product candidates.
Allegro Diagnostics is a molecular diagnostics company focused on the development and commercialization of innovative genomic tests for the diagnosis, staging and informed treatment of lung cancer and other lung diseases. Allegro has developed a molecular testing platform that utilizes a genomic signature to detect early signs of lung cancer in current and former smokers. The Company’s lead product is the BronchoGen™ genomic test for use in combination with standard bronchoscopy for the diagnosis of lung cancer.