NCI awards $2.8 million grant to Allegro Diagnostics

Allegro Diagnostics, a leader in the field of molecular diagnostics for lung cancer, has announced that its clinical study for BronchoGen(TM), a diagnostic test for patients suspected of having lung cancer, will receive up to $2.8 million in funding for a Phase I/II Fast Track Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI). This groundbreaking clinical study is enrolling up to 800 patients at 12 sites in the U.S. If successful, BronchoGen(TM) would be a first in class, novel test in an area of significant unmet medical need.

"Bravo to Allegro Diagnostics," said Laurie Fenton Ambrose, President & CEO of Lung Cancer Alliance (LCA), the only national organization providing patient support and advocacy solely to those living with or at risk for the disease, "for making earlier, more accurate diagnosis of suspected lung cancer a research a priority. It is our hope that this trial will prove successful and ultimately bring important benefits to both doctors and patients - something long overdue. We look forward to closely monitoring the progress of this research and team of world class leaders."

"The elegant technology developed by Allegro scientists could be a very valuable piece of our quest to diagnose lung cancer as early and accurately as possible, and in a cost effective manner. I look forward to the study," commented Steve Shapiro, MD, Professor and Chairman of the Department of Medicine at University of Pittsburgh.

BronchoGen(TM) uses easily accessible cells lining the airway (bronchial epithelial cells) obtained during bronchoscopy and analyzes their RNA to measure gene expression levels. Allegro's scientific team has found that specific sets of genes are over- and under-expressed in current or former smokers with lung cancer as compared to those without lung cancer. This finding was validated in a 164 patient study published in Nature Medicine in March, 2007. Importantly, the BronchoGen(TM) approach does not require an actual tissue sample from a suspicious nodule or lesion, which often must be accessed through highly invasive procedures that pose significant risks to the patient.

Bronchoscopy is one of the most common diagnostic modalities used to assess patients for suspicion of lung cancer. Performed over 300,000 times a year in the U.S. in such patients, bronchoscopy has relatively low sensitivity for detecting disease in those patients who have it, leading to a high number of false negative results. Guidelines from the American College of Chest Physicians state that when a bronchoscopy is non-diagnostic or negative and suspicion of lung cancer remains, a clinician should pursue additional diagnostic procedures to assess the patient's status.

"The NCI support for our trial is highly encouraging news for current or former smokers at risk for lung cancer, and will propel the development of BronchoGen(TM). It will also help Allegro Diagnostics extend its scientific platform into other areas," said Dan Rippy, President & CEO of Allegro. "Lung cancer patients generally have a very poor prognosis because most are diagnosed with late stage disease. BronchoGen(TM) may help clinicians to detect disease earlier and reduce unnecessary medical procedures in those patients who do not have lung cancer."

"The NCI grant recognizes the importance of developing new and innovative approaches to the diagnosis and treatment of lung cancer," said Jerome Brody, MD, chief scientific officer, co-founder of Allegro Diagnostics and an author on the Nature Medicine study. "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."

"This test could be a real breakthrough," said Frank Hull, MD, of Broward Health in Fort Lauderdale, Florida. "My patients are very anxious once they are told they have a lung nodule that could be cancer. Particularly in small lung nodules below the resolution of PET scanning and difficult to accurately biopsy, this test could result in earlier treatment in patients with lung cancer. In patients with benign nodules this could save two years of anxiety, which is the usual time period that we follow these lung nodules with serial imaging before we ascertain them as benign."

"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," said Ali Andalibi, Ph.D., Program Director with the National Cancer Institute.

SOURCE Allegro Diagnostics