Allegro Diagnostics is celebrating positive preliminary data from the first of two clinical trials for its new BronchoGen molecular diagnostic test for lung cancer. Armed with the encouraging news, CEO Mike Webb says the company plans to launch the test commercially in the 2013 first quarter.
"The preliminary results are really good," Webb told FierceMedicalDevices during a telephone interview from the annual CHEST meeting in Atlanta, where the Maynard, MA, company formerly presented the results. He added the company is seeking "co-promotion arrangements with several large companies who call on the pulmonology community" and hopes to have a partner in place by the first half of next year.
Plans still call for supporting the commercialization with a $15 million to $20 million Series B round, which the company hopes to close in the 2013 first quarter, Webb said. He added the company plans to seek CLIA certification.
BronchoGen is for use after a bronchoscopy on its own is either unsuccessful or inconclusive. The test conducts a genetic profile on cytologically normal tissue from the upper airway that can help diagnose lung cancer that a less precise bronchoscopy procedure can miss; half of the 300,000 bronchoscopies performed annually are inconclusive.
Allegro touted preliminary results from AEGIS I, a prospective, case-controlled multi-center study designed to evaluate how accurate BronchoGen is in predicting lung cancer compared to and in combination with a bronchoscopy. The total trial involved 730 patients, and preliminary results analyzed 330 patient samples (240 with confirmed cancers and 90 controls). For the trial, Allegro successfully converted its genomic test from several hundred genes down to a 30-gene signature on the reverse transcriptase polymerase chain reaction (RT-PCR) format--a format important for successful commercial testing.
The results: The PCR-based test produced a 77% sensitivity on its own and a 73% specificity. Combined with bronchoscopy results it generated a 94% sensitivity, versus 74% for bronchoscopy on its own. And the negative predictive value of the combined test reached .85, versus .65 for a bronchoscopy alone--suggesting a much stronger result when the test was used with bronchoscopy. Webb said the results from the remainder of AEGIS I will come out by the end of this year. A second, larger trial involving 1,300 patients completed enrollment in July 2012 and is slated to deliver final results in July 2013.
- read the release