Allegro Diagnostics claims to have successfully reached its primary endpoint in the first of two massive clinical trials for its BronchoGen lung cancer genomic diagnostic, putting the test on track for a late 2013 launch--a bit later than initially projected.
While the new data hasn't been published yet in a peer-reviewed publication (a submission is pending), the Maynard, MA, company insists that the AEGIS I trial successfully showed that BronchoGen boosts the accuracy of lung cancer diagnosis when used in conjunction with a bronchoscopy. The test is designed to identify cancerous tumors from cytologically normal tissue in the upper airway of the lung, something that bronchoscopies can miss on their own because they're not as precise.
President and CEO Michael Webb said in a statement that the test did particularly well with small lesions and early-stage lung cancer, and that the results place the test on track for a late 2013 launch as per CLIA regulations.
"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," Webb said.
Allegro released preliminary data in October for AEGIS I, a trial involving 730 patients. Those early results pointed to something good, with the PCR-based genomic test producing a 94% sensitivity in combination with bronchoscopy, versus 74% for bronchoscopy alone. On its own, BronchoGen generated a 77% sensitivity and 73% specificity. Allegro said it repeated the results in its clinical validation study. More than 1,300 patients are taking part in a large trial dubbed AEGIS II, and those results are expected in the 2013 third quarter.
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