NEW YORK (GenomeWeb News) – Allegro Diagnostics has won up to $2.8 million in funding from the National Cancer Institute for clinical studies of its BronchoGen, a molecular diagnostic test for early-stage lung cancer.
The company said today that it will use the Phase I and II Fast Track Small Business Innovation Research funding for a study that will enroll up to 800 patients in 12 sites in the US.
"The grant will accelerate Allegro Diagnostics' current clinical trial aimed at validating BronchoGen as an early lung cancer diagnostic tool and will assist in developing a series of additional genomic tests that could help lessen the human toll of the leading cause of cancer death in the US and the world," Allegro Diagnostics CSO and Co-founder Jerome Brody said in a statement.
The BronchoGen test analyzes RNA to measure gene expression levels using epithelial cells that were taken during bronchoscopy. The company said it has found that specific sets of genes are over-and under-expressed in current and former smokers with lung cancer compared to those without lung cancer, a finding it said was validated through a 164-patient study.
Bronchoscopy, which is performed over 300,000 times per year in the US, has a low sensitivity for detecting disease and would benefit from follow-up diagnostics when it is not conclusive, the company said. The BronchoGen test would not require that an actual tissue sample be removed from a suspicious nodule or lesion, it added.
"The development of technologies that can aid in the accurate diagnosis of lung cancer based on analysis of (bronchial) samples is likely to result in less discomfort to patients and may help bring down costs associated with diagnostic testing," NCI Program Director Ali Andalibi said.