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First Diagnostic Test to Confirm Chronic Sinusitis Is Now Available

The first diagnostic test available for the confirmation of chronic sinusitis has just been made available by Accentia Biopharmaceuticals, Inc. The name of the patented test is CRSFungal Profile and is now available to ear, nose and throat specialists and allergists nationwide to help them get an accurate diagnosis of chronic sinusitis.

Historically, the diagnosis of chronic sinusitis has been made based on a doctor's subjective assessment of a combination of the patients' symptoms, nasal endoscopy, and CT scan of the sinuses. Until the release of CRSFungal Profile, there has been no confirmatory diagnostic test for the disease.

Published studies by researchers at the Mayo Clinic in Rochester, Minnesota have provided substantial evidence that the underlying cause for chronic sinusitis may be the presence of fungi, in the mucus layer of the nasal and sinus cavities. While fungi are present in the majority of the population, it is an inflammatory response in susceptible patients that causes chronic sinusitis, according to Mayo Clinic. This research has led to a better understanding of the condition and it has led to the development of new treatment strategies targeting the fungal etiology.

CRSFungal Profile enables physicians to test for the specific protein marker, eosinophil Major Basic Protein (eMBP), as well as one of the fungi that causes chronic sinusitis. The test uses a small sample of mucus from the patient's nasal cavities. The mucus sample is sent by the physician to IMMCO Diagnostics Inc. (IMMCO) of Buffalo, NY where it is analyzed by immunoassay. Typically, results are made available to the physician within 72 hours.

"Chronic sinusitis is extremely debilitating to the millions of sufferers worldwide. The improvements in diagnostic testing will make it easier for the practitioner to appropriately treat these patients," said Dr. David Sherris, Professor and Chairman, Department of Otolaryngology, University of Buffalo. "In clinical studies, patients with chronic sinusitis were positive for the eMBP protein in their mucus, but it was not detected in patients with allergic rhinitis or in normal patients."

"We are excited to partner with IMMCO on this groundbreaking tool for diagnosing CS,” said Gary Cantrell, Executive Vice President Sales and Marketing of specialty pharmaceuticals at Accentia. “Existing interventions have been largely limited to the use of inhaled or oral corticosteroids, decongestants, anti-histamines, and sinus surgery but we believe that these interventions do not address the underlying cause of the inflammation. This is the only test on the market that physicians can use to assist in the diagnosis of CS based on the underlying etiology.”

CRSFungal Profile allows doctors to test for what may be causing the chronic sinus infections and, if that protein or fungi exists in test, doctors can more accurately diagnose chronic sinusitis as opposed to similar conditions such as allergic rhinitis. This could help sinusitis sufferers get proper treatment earlier than with previous diagnosis methods.


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