Allegro Diagnostics is on track to launch a major clinical trial of its lung cancer test this year after a long process, completed in October, of designing the goals of the study and submitting paperwork on it to the FDA, CEO Dan Rippy says.
The FDA has granted the Boston-based startup conditional approval to conduct an 800-patient study of its genetic test for lung cancer; the company expects to begin enrollment early this year. The hope is that the trial will lead to product clearance from the FDA, but Rippy says it’s too soon to predict when that may happen. Last year the company secured a $2.8 million Small Business Innovation Research grant from the National Cancer Institute to support the study.
The company also hopes to get permission, under a separate program run by the U.S. Centers for Medicare and Medicaid Services (CMS), to get paid to analyze samples with its lung cancer-screening technology in its own labs in the second half of 2010, Rippy says. Pursuing both paths at the same time could protect the firm if the rules for how such diagnostics are regulated change.
“It certainly has been a dynamic and evolving [regulatory] process,” Rippy says. “At the end of the day, Allegro wants to do world-class science, and so we want to and intend to be compliant with whatever regulations emerge.”
Allegro‘s efforts are significant because the firm offers a new, genetic-based approach to detecting lung cancer that has the potential to spot tumors before they spread out of control. Allegro’s test screens cells from the lining of a patient’s airway for RNA molecules that show whether certain genes linked to lung cancer are overactive or underactive. The cells are collected as part of a procedure called a bronchoscopy, during which a scope is placed down a patient’s nose or throat to look in the lungs for suspicious tissues that could be cancerous. Bronchoscopy has historically yielded many false positives, according to Rippy; Allegro’s test is intended to boost its accuracy. Doctors also use X-rays, CT scans, and biopsies to detect lung cancer. Yet medical images can be misleading, and doing surgeries to gather tissue samples from the lungs is more invasive than Allegro’s method. (Rippy discussed some of this with Xconomy when he spoke to us back in March 2008.)
Molecular tests like Allegro’s are viewed as the next frontier for diagnosing lung cancer. Naturally, there’s competition in this field. For instance,
