— Confirmatory AEGIS II Study Recently Completed Enrollment —
Maynard, MA, August 27, 2012. Allegro Diagnostics today announced that results from its AEGIS (Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer) clinical trials, to determine the accuracy of the BronchoGen™ genomic test, have been accepted for an oral presentation during the late-breaking abstract session at CHEST 2012 on Tuesday, October 23, 2012 at 4:30 p.m. The abstract will also be published in a supplement of the October 2012 issue of CHEST. BronchoGen™ is Allegro Diagnostics’ lead genomic test, and it is built upon the Company’s molecular testing platform that utilizes gene expression of normal epithelial cells in the respiratory tract to detect signs of lung cancer. CHEST 2012 is the 78th annual meeting of the American College of Chest Physicians and is being held at the Georgia World Congress Center in Atlanta, October 20-25, 2012.
“The goal for our first clinical trial analysis is to show significantly higher negative predictive value in lung cancer diagnoses using BronchoGen,” said Duncan Whitney, Senior Vice President, Research, Development and Technical Operations of Allegro Diagnostics and the study’s director. “We are eager to present our data that was obtained using RT-PCR at CHEST in October. We plan to use the PCR platform for routine clinical testing in the next year.”
“BronchoGen may enable physicians to better diagnose patients suspected of having lung cancer, avoiding more costly and invasive procedures to confirm the disease,” said Michael D. Webb, President and Chief Executive Officer of Allegro Diagnostics. “To date, Allegro has met all milestones as part of our development strategy for the BronchoGen genomic test, and we are currently preparing for its commercialization.”
About the AEGIS Trials
The Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer (AEGIS) trials are prospective, multi-center studies designed to evaluate the prediction accuracy of the BronchoGen™ genomic test compared to and in combination with bronchoscopy. The over 2,000-patient trials have been conducted at 25 medical centers throughout the United States, Canada and Ireland. Endpoints include the sensitivity, specificity, negative predictive value and positive predictive value of BronchoGen for identifying patients with malignancy. Complete results from the first clinical validation study are expected to be released later in 2012.
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. 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.
About Allegro Diagnostics
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.