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.