Accentia test to diagnose chronic sinusitis enters commercial market

By Ted A. Knutson

Washington, Nov. 29 - Accentia Biopharmaceuticals, Inc. announced Tuesday the commercial introduction of its non-invasive test, CRSFungal Profile, by its specialty pharmaceuticals division, Teamm Pharmaceuticals, to assist in the diagnosis of chronic sinusitis.

In partnership with the licensee for this patented technology, IMMCO Diagnostics Inc. of Buffalo, NY, Accentia is making CRSFungal Profile available to ear, nose and throat specialists and allergists nationwide, Accentia said in a news release.

Accentia said chronic sinusitis is one of the most common chronic diseases suffered by Americans, affecting an estimated 31 million patients.

Chronic sinusitis, or CS, otherwise known as Chronic rhinosinusitis, is a chronic inflammatory disease of the nasal and sinus mucosa that persists for greater than three months. 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.

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.

Mayo Clinic research has 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.

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 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.

Tampa, Fla.-based Accentia is a biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology.

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