Allegro Diagnostics Announces BronchoGenTM Genomic Test for Improved Diagnosis of Lung Cancer Successfully Achieves Clinical Validation
03.12.2013

-- BronchoGen Test to Become Available to Patients and Physicians in 2013 --

MAYNARD, Mass.--(BUSINESS WIRE)-- Allegro Diagnostics today announced that the AEGIS I clinical trial has met its primary endpoint, demonstrating that the BronchoGenTM 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. Allegro plans to submit the complete results from the clinical trial for publication in a peer-reviewed journal.

Preliminary data were previously presented at the 78th annual meeting of the American College of Chest Physicians (CHEST) on October 23, 2012, where the Company reported that the test combined with results from bronchoscopy yielded a sensitivity of 94% (95% confidence interval (C.I.), 91-97%), compared to a sensitivity of only 74% for bronchoscopy alone. In that same presentation Allegro had reported a 28 percentage point improvement in the negative predictive value (NPV) of BronchoGen in combination with bronchoscopy, compared to bronchoscopy alone. Allegro is pleased to report that these results were replicated in its clinical validation study and will move forward with commercialization plans.

"The great results that we have seen from the AEGIS I trial enable us to offer the BronchoGen genomic test as part of routine clinical testing for lung cancer, and we are currently developing our commercial program to make the test available later in 2013 under CLIA regulations," said Michael D. Webb, President and Chief Executive Officer of Allegro Diagnostics. "We are particularly pleased with the excellent performance of BronchoGen in small lesions and early-stage disease. Half of bronchoscopies performed result in an inconclusive cancer diagnosis, leading to costly and risky invasive diagnostic and surgical procedures. BronchoGen has the potential to improve dramatically upon this current diagnostic standard of care, especially for cases where bronchoscopy alone is most challenging in patients with difficult to detect disease."

"We continue to see excellent results in the ability of BronchoGen to aid in predicting the presence or absence of lung cancer, 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 & 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 I) trial is a prospective, case-controlled, multi-center study designed to evaluate the prediction accuracy of the BronchoGenTM genomic test compared to bronchoscopy alone 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 enrolled in AEGIS II. All patients have been current or former smokers undergoing bronchoscopy for suspicion of lung cancer. Endpoints include the sensitivity, specificity and negative predictive value of BronchoGen for identifying patients with malignancy. The AEGIS II trial completed patient enrollment in July 2012 with final results expected in Q3 2013.

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. Allegro has applied this platform in multiple research programs for the detection of COPD in addition to lung cancer. Lung cancer tests based on sampling from the bronchus (BronchoGenTM) and from the nasal passage (NasoGenTM) have resulted from Allegro Diagnostics' platform and are currently under development.

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 BronchoGenTM genomic test for use in combination with standard bronchoscopy for the diagnosis of lung cancer. www.allegrodx.com

Contacts
MacDougall Biomedical Communications
Kari Watson or Charles Liles, 781-235-3060
kwatson@macbiocom.com or cliles@macbiocom.com