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For those who do inhale
August 2011
by Kimberley Sirk  |  Email the author


MAYNARD, Mass.—Allegro Diagnostics announced a partnership agreement in late June that will grant it an exclusive license agreement with two universities related to Allegro's developing molecular testing platform. This platform utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer.  
This agreement, for now, specifically relates to the BronchoGen genomic test, which will be Allegro's first commercially available product. Company officials say the test has the potential to be incorporated into standard bronchoscopy procedures to provide additional critical diagnostic information to support more rapid diagnosis and treatment. A 2012 launch of the laboratory test is expected, and the service will be offered to pulmonologists across the United States.  
According to Mike Webb, president and CEO of Allegro Diagnostics, the new platform will help reduce uncertainty of diagnosis with the current state-of-the-art test.  
"Bronchoscopy in the U.S. produces an inconclusive result one half to three-quarters of the time," Webb says. "That's 150,000 to 200,000 patients a year who are tested where the results are uncertain."  
Allegro's platform is based on the "field-of-injury" principle. According to Webb, researchers at Boston University originated this field-of-injury work.  
The principle refers to the common molecular response that occurs throughout the respiratory tract in current and former smokers with lung cancer. When a smoker inhales smoke, his entire respiratory tract is bathed in a laundry list of toxins contained in that smoke. Those harmful compounds cause gradual changes in the entire tract. 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.  
Webb says the testing platform is sensitive enough that it can pick up genomic signals in the airway that can indicate that the patient is a current or even former smoker.  
"Since the epithelial cells that line the entire airway are impacted and can be tested by this platform," he says, "we can learn that there is a tumor in a patient's lung from a genomic signal in healthy tissue in, for example, the nose."  
Bronchoscopy is a much more invasive procedure, and is performed on an outpatient basis.   BronchoGen is used in the upper chest, and will be employed with standard bronchoscopy for the early diagnosis of lung cancer.  
Webb says his company is committed to bringing early lung cancer detection to the standard of care.  
"The licensing agreement with Boston University and the University of Utah Foundation helps us to achieve that goal by supporting our continued advancement of this breakthrough platform, including the planned commercial launch of BronchoGen in the first half of 2012," says Webb.  
He says the discovery of the technology resulted from the Boston University research work, some of which was conducted by a now-faculty member at the University of Utah. The work has been reported in medical journals.  
"We believe Allegro's application of this platform to innovative genomic tests will change the future of diagnosing lung cancer, with the ultimate potential of saving lives," said Dr. Avrum Spira, director of the Clinical and Translational Science Institute of Boston University and co-founder of Allegro, in a prepared statement. "We are pleased that technology developed at our institution may enable the early detection of lung cancer, and therefore, we are excited to enter into this license agreement with Allegro."  
Allegro has applied this platform to generate multiple product candidates. Down the road, the company plans to introduce NasoGen, which is under development to test cell samples from the nose, as Webb envisions.  
Webb says commercialization of the test could likely be global: although the dangers of smoking are well documented in the United States, he says smoking remains prevalent around the world. Even with recently strengthened warnings, Webb says current estimates indicate that the total population of current and former smokers in the United States alone is 90 million. Eighty-five to 90 percent of lung cancer patients are current or former smokers.  
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. Currently, it is in "semi-virtual mode," as its CEO says, but plans to put down firm roots and aspires to CLIA lab status after its 2012 product launch.

Allegro Dx closes on $5.4 million financing
MAYNARD, Mass.—On July 11, Allegro Diagnostics announced the closing of $5.4 million in a Series A extension financing. The company's existing venture investors, Kodiak Venture Partners and Catalyst Health Ventures, participated in the round.  
The company said proceeds from the financing will support the commercialization of its lead genomic test, BronchoGen, in 2012.  
"This support from our existing investors reflects their enthusiasm for Allegro's focus on early lung cancer detection," said Michael D. Webb, president and CEO of Allegro Diagnostics, in a statement. "Approximately 300,000 bronchoscopic exams are performed each year, but the majority of the results are inconclusive. As a consequence, most individuals with suspected lung cancer do not receive a definitive diagnosis, and therefore may not receive treatment until it is too late. The BronchoGen genomic test has been developed to fill this gap. When used alongside standard bronchoscopy procedures, BronchoGen is intended to provide additional critical diagnostic information much earlier in the diagnostic process."
Allegro is leading a new paradigm for lung cancer management by introducing the potential for early detection, and this approach "has great promise both clinically and commercially," said Andrey Zarur, managing partner at Kodiak Venture Partners.  
"Lung cancer is the leading cancer killer, and, unfortunately, 70 percent of patients are not diagnosed until they have progressed to late-stage disease," Zarur added. "BronchoGen is designed to support earlier diagnosis, which may potentially reduce mortality and healthcare costs."

Code: E081117



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