Allegro Diagnostics Releases Positive Clinical Results for Lung Cancer Test
03.13.2013

IVDTInsignt

March 16, 2013

Posted: March 13, 2013

Allegro Diagnostics, a healthcare products manufacturer based in Maynard, Massachusetts, announced [2] that a clinical trial of its BronchoGen genomic test reached its primary endpoint. According to a press release by the company, the BronchoGen diagnostic test is effective at diagnosing lung cancer when combined with a traditional bronchoscopy.
It its press release, the company detailed how the test works. It utilizes cytologically normal epithelial cells in a patient's respiratory tract. When an individual has lung cancer, the disease doesn't just impact a patient's lungs. Instead, lung cancer causes detectable molecular changes in a patient's respiratory tract. This "field of injury" creates a tell-tale gene expression signature that can indicate lung cancer. In addition, the technology behind this diagnostic can be used for the detection of chronic obstructive pulmonary disease.

Early results from the clinical trial were presented in October of last year at an American College of Chest Physicians conference. When combined with bronchoscopy, Allegro's genomic test show a 94 percent sensitivity. Bronchoscopy on its own yielded a sensitivity of 74 percent.

Michael D. Webb, CEO and president of Allegro Diagnostics, said in prepared remarks, "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, and we are currently developing our commercial program to make the test available later in 2013 under CLIA regulations."


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