Accentia Biopharmaceuticals, Inc. launches CRSFungal Profile™

11/28/05

The first diagnostic test available for the confirmation of Chronic Sinusitis disease affecting 31M Americans.

Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI) , announced today the commercial introduction of a patented, non-invasive test, CRSFungal Profile, by its specialty pharmaceuticals division, TEAMM Pharmaceuticals, to assist in the diagnosis of Chronic Sinusitis (CS) otherwise known as Chronic Rhinosinusitis (CRS). In partnership with the licensee for this patented technology, IMMCO Diagnostics Inc. (IMMCO) of Buffalo, NY, Accentia Biopharmaceuticals is making CRSFungal Profile available to ear, nose and throat (ENT) specialists and allergists nationwide.

CS is one of the most common chronic diseases suffered by Americans today, affecting an estimated 31 million patients in the US. CS is a chronic inflammatory disease of the nasal and sinus mucosa that persists for greater than three months. Long-term consequences include the formation of inflammatory polyps in the nose. The inflammation of CS results in symptoms that include nasal congestion, mouth breathing, nasal discharge, and post-nasal drip. This chronic non-infectious inflammation predisposes patients to acute exacerbations of their sinusitis due to bacterial superinfection, which requires oral antibiotic therapy. Many patients with severe disease resort to sinus surgery in an effort to reduce nasal obstruction and improve sinus drainage. Historically, the diagnosis of CS 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. 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 CS is 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 CS. 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 ProfileTM enables physicians to test for the specific protein marker, eosinophil Major Basic Protein (eMBP), as well as one of the fungi that causes CS. The test uses a small sample of mucus from the patient's nasal cavities. The mucus sample is sent by the physician to IMMCO 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. 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" said Gary Cantrell, Executive Vice President Sales and Marketing of specialty pharmaceuticals at Accentia.

Source: Eurekalert & others

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