By Don Seiffert
Allegro Diagnostics Corp. has completed enrollment in a 1,320- patient clinical trial to evaluate the diagnostic ability of its BronchoGen genomic test used in conjunction with bronchoscopy to detect early signs of lung cancer.
The Maynard-based company said in a statement that the so-called AEGIS II (Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer) study will compare BronchoGen in conjunction with bronchoscopy to bronchoscopy alone.
Data from the study are expected in mid-2013, but later this year, data from the 730-patient AEGIS I trial of the diagnostic accuracy of BronchoGen will be announced.
“Over half of the more than 300,000 bronchoscopies performed annually in the United States in patients at high risk for lung cancer result in an inconclusive cancer diagnosis,” said Michael D. Webb, president and CEO, in a statement. “We believe that BronchoGen has the potential to improve dramatically upon the current diagnostic standard of care.”
BronchoGen is Allegro’s lead genomic test, and is built on the company’s molecular testing platform using gene expression of normal epithelial cells in the respiratory tract which it acquired in June 2011 in an exclusive licensing deal with Boston University and the University of Utah Foundation.
Allegro Diagnostics Corp. was founded in 2006 by Jerome Brody, M.D., and Avrum Spira, M.D., faculty at the Boston University School of Medicine. The company is backed by Kodiak Venture Partners and Catalyst Health Ventures, and has raised $9.6 million in venture financing as well as $3.1 million in competitive research and development grant funding