Breakthrough: The Maynard, MA, company's BronchoGen molecular diagnostic test can help spot lung cancer from cytologically normal tissue in the upper airway that a less precise bronchoscopy procedure can miss.
Background: Allegro, launched in 2006, released preliminary data in October 2012 from the first of two massive trials. One, known as AEGIS I, involved 730 patients and the analysis of 330 patient samples, 240 of which had confirmed cancers, with 90 controls. The PCR-based genomic test produced a 77% sensitivity on its own and a 73% specificity. But combined with bronchoscopy, it generated a 94% sensitivity versus 74% for bronchoscopy on its own. (A second, larger trial involving 1,300 patients is pending.)
Significance: Lung cancer diagnosis isn't very precise with current care options. More than 300,000 bronchoscopies, for example, are performed annually in the U.S., and half produce an inconclusive diagnosis. BronchoGen would fill a diagnostics void, producing a valid, positive lung cancer diagnosis from seemingly normal tissue that bronchoscopies often miss.
Next steps: Data is promising enough that plans are under way to launch the test commercially in 2013.
Allegro celebrates encouraging early data for lung cancer test