MAYNARD, Mass.—Allegro Diagnostics announced a partnershipagreement in late June that will grant it an exclusive license agreement withtwo universities related to Allegro's developing molecular testing platform.This platform utilizes gene expression of normal epithelial cells in therespiratory tract to detect early signs of lung cancer.
This agreement, for now, specifically relates to theBronchoGen genomic test, which will be Allegro's first commercially availableproduct. Company officials say the test has the potential to be incorporatedinto standard bronchoscopy procedures to provide additional critical diagnosticinformation to support more rapid diagnosis and treatment. A 2012 launch of thelaboratory test is expected, and the service will be offered to pulmonologistsacross the United States.
According to Mike Webb, president and CEO of AllegroDiagnostics, the new platform will help reduce uncertainty of diagnosis withthe current state-of-the-art test.
"Bronchoscopy in the U.S. produces an inconclusive resultone half to three-quarters of the time," Webb says. "That's 150,000 to 200,000patients 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 BostonUniversity originated this field-of-injury work.
The principle refers to the common molecular response thatoccurs throughout the respiratory tract in current and former smokers with lungcancer. When a smoker inhales smoke, his entire respiratory tract is bathed ina laundry list of toxins contained in that smoke. Those harmful compounds causegradual changes in the entire tract. These changes can be detected in a geneexpression signature from non-malignant airway cells and indicate the presenceof malignancy remotely in the lung.
Webb says the testing platform is sensitive enough that itcan pick up genomic signals in the airway that can indicate that the patient isa current or even former smoker.
"Since the epithelial cells that line the entire airway areimpacted and can be tested by this platform," he says, "we can learn that thereis a tumor in a patient's lung from a genomic signal in healthy tissue in, forexample, the nose."
Bronchoscopy is a much more invasive procedure, and isperformed on an outpatient basis.
BronchoGen is used in the upper chest, and will be employedwith standard bronchoscopy for the early diagnosis of lung cancer.
Webb says his company is committed to bringing early lungcancer detection to the standard of care.
"The licensing agreement with Boston University and theUniversity of Utah Foundation helps us to achieve that goal by supporting ourcontinued advancement of this breakthrough platform, including the plannedcommercial launch of BronchoGen in the first half of 2012," says Webb.
He says the discovery of the technology resulted from theBoston University research work, some of which was conducted by a now-facultymember at the University of Utah. The work has been reported in medicaljournals.
"We believe Allegro's application of this platform toinnovative genomic tests will change the future of diagnosing lung cancer, withthe ultimate potential of saving lives," said Dr. Avrum Spira, director of theClinical and Translational Science Institute of Boston University andco-founder of Allegro, in a prepared statement. "We are pleased that technologydeveloped at our institution may enable the early detection of lung cancer, andtherefore, we are excited to enter into this license agreement withAllegro."
Allegro has applied this platform to generate multipleproduct candidates. Down the road, the company plans to introduce NasoGen,which is under development to test cell samples from the nose, as Webbenvisions.
Webb says commercialization of the test could likely beglobal: although the dangers of smoking are well documented in the UnitedStates, he says smoking remains prevalent around the world. Even with recentlystrengthened warnings, Webb says current estimates indicate that the totalpopulation of current and former smokers in the United States alone is 90million. Eighty-five to 90 percent of lung cancer patients are current orformer smokers.
Allegro Diagnostics is a molecular diagnostics companyfocused on the development and commercialization of innovative genomic testsfor the diagnosis, staging and informed treatment of lung cancer and other lungdiseases. Currently, it is in "semi-virtual mode," as its CEO says, but plansto put down firm roots and aspires to CLIA lab status after its 2012 productlaunch.
Allegro Dx closes on $5.4 million financing
MAYNARD, Mass.—On July 11, Allegro Diagnostics announced theclosing of $5.4 million in a Series A extension financing. The company'sexisting venture investors, Kodiak Venture Partners and Catalyst HealthVentures, participated in the round.
The company said proceeds from the financing will supportthe commercialization of its lead genomic test, BronchoGen, in 2012.
"This support from our existing investors reflectstheir enthusiasm for Allegro's focus on early lung cancer detection," saidMichael D. Webb, president and CEO of Allegro Diagnostics, in a statement."Approximately 300,000 bronchoscopic exams are performed each year, but themajority of the results are inconclusive. As a consequence, most individualswith suspected lung cancer do not receive a definitive diagnosis, and thereforemay not receive treatment until it is too late. The BronchoGen genomic test hasbeen developed to fill this gap. When used alongside standard bronchoscopyprocedures, BronchoGen is intended to provide additional critical diagnosticinformation much earlier in the diagnostic process."
Allegro is leading a new paradigm for lung cancer managementby introducing the potential for early detection, and this approach "has greatpromise both clinically and commercially," said Andrey Zarur, managingpartner at Kodiak Venture Partners.
"Lung cancer is the leading cancer killer, and,unfortunately, 70 percent of patients are not diagnosed until they haveprogressed to late-stage disease," Zarur added. "BronchoGen is designed tosupport earlier diagnosis, which may potentially reduce mortality andhealthcare costs."