First Chronic Rhinosinusitis Diagnostic Test Ready for Market

Beginning in June 2013, doctors can simply send a sample of nasal mucus to Immco Diagnostics Inc. to test for the major basic protein.

“This is a game-changer,” says UB ear, nose and throat researcher Jens U. Ponikau, MD, clinical assistant professor of otolaryngology.

“It provides physicians with a way to precisely identify what kind of inflammation is present in the nose and can help guide their treatment approach.”

Ponikau and David A. Sherris, MD, professor and chair of otolaryngology, discovered that chronic rhinosinusitis develops from tissue damage caused by the protein.

This protein is released by eosinophils, or rare white blood cells that travel through the nasal skin into the mucus.

Since the discovery of this immunologic cause, researchers around the world have worked to confirm that the protein is specific to CRS.

Because the airway inflammation in CRS is usually due to fungi, not bacteria, the new test can help identify patients who may not benefit from antibiotics, notes Lakshmanan Suresh, PhD, clinical associate professor of oral diagnostic sciences in the UB School of Dental Medicine and vice president of research and development and clinical services at Immco Diagnostics.

The test also may help patients forgo much more invasive treatment.

Some have undergone endoscopic surgery in hopes of getting some relief, but often the disease comes back, Ponikau says.

The new test fills a serious unmet need for the more than 30 million Americans—about 14 percent of the U.S. population—who suffer from chronic rhinosinusitis.

The condition has been difficult to diagnose and treat because its symptoms—including nasal congestion, thick mucus, headache, loss of the sense of smell and bacterial infections—mimic those of other common illnesses.

“Physicians have not had sufficient insight into what causes it,” Ponikau says. “Is it a year-round allergy, a deviated septum, the common cold, some recurrent bacterial infection or chronic sinusitis?”

“Until now, there were few ways to tell.”

The research team, which recently led clinical trials of the test, also includes Kishore Malyavantham, PhD, of Immco Diagnostics.

The Amherst, N.Y. firm has licensed the immunologic test from the Mayo Clinic, where the UB researchers initially developed it.