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Trial Shows Gene Test Improves Lung Cancer Diagnostics

Illustration of lungs (Mikael Häggström/Wikimedia Commons)

(Mikael Häggström/Wikimedia Commons)

2 April 2014. Allegro Diagnostics Corp. in Maynard, Massachusetts says results from a clinical trial testing its genomic technique for diagnosing lung cancer more accurately predicts development of the disease among former smokers than standard bronchoscopies working alone. The company plans to discuss the findings next month at an American Thoracic Society meeting in San Diego, as well as submit the results to a peer-reviewed scientific journal.

Allegro’s technology detects the gene expression of cells from the surface of airways to provide doctors with a much earlier diagnosis of the disease, when more treatment options are available. According to American Cancer Society, lung cancer is the leading cause of cancer death, with the majority of cases diagnosed after age 65, and the risk of contracting the disease much higher among smokers. The five-year survival rate for non-small cell lung cancer, which accounts for about 85 percent of cases, decreases sharply as initial diagnosis occurs later in the progress of the disease.

The BronchoGen test, as the company calls it, detects molecular changes in cells lining the airways, which are correlated with lung cancer. The test is designed to supplement standard bronchoscopy, where a tube is passed through the nose or mouth into the lungs to allow for visual examination with a small camera. Allegro says bronchoscopies alone result in a large percentage of inconclusive results or false negatives, leading to needless surgeries in some cases.

The clinical trial reported by the company tests the accuracy of BronchoGen to detect early molecular changes in cells lining the airways of former smokers. Preliminary results of the trial, reported in 2012 at a meeting of American College of Chest Physicians, gave results from 240 patients with confirmed lung cancer and 90 controls. The results showed BronchoGen combined with bronchoscopy improved the sensitivity of cancer diagnosis to 94 percent, compared to 74 percent for bronchoscopy alone. The BronchoGen alone, however, did not fare much better at 77 percent.

The new results report findings from a larger pool of patients of some 1,000 patients enrolled at 21 sites in the U.S., followed for as long as 12 months for signs of lung cancer.  Allegro says the combination of BronchoGen and bronchoscopy met all of the trial’s main objectives — sensitivity, specificity and negative predictive value for identifying patients with malignant lung cancer — and validate the preliminary findings.

Allegro Diagnostics was founded in 2006 by Jerome Brody and Avrum Spira, both faculty members at Boston University medical school. Spira continues as the company’s chief science and medical advisor.

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