Sarasota, Fl (PRWEB) November 25, 2013
Rapid Pathogen Screening, Inc. (RPS®) today announced that the U.S. Food and Drug Administration (FDA) has cleared InflammaDry® – a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease – for sale in the United States.
Dry eye is a multifactorial disease that often leads to inflammation and results in discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. It is estimated that more than 30 million people suffer from dry eye in the United States. Factors contributing to dry eye disease include age, environment, medical conditions, and hormonal changes, among others. Accurate diagnosis of dry eye is especially critical before ocular surgery is performed. Clinical studies by Fournié and Mutoh have demonstrated that diagnosis and treatment of dry eye disease prior to refractive surgery has resulted in improved healing and reduced complications.
InflammaDry is the first and only, rapid, in-office test to detect matrix metalloproteinase 9 (MMP-9), a clinically relevant inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. The test plays an essential role in accurately diagnosing dry eye disease, as clinical signs of the condition resemble other eye ailments and are not always directly related to patient complaints.
“FDA’s clearance of the InflammaDry test is another important milestone for RPS,” said Robert Sambursky, MD, chief executive officer, president, and chairman of RPS. “InflammaDry will help clinicians confirm the diagnosis of dry eye before the patient leaves their office, resulting in more timely and appropriate management of their disease.”
InflammaDry is an affordable, single-use test that requires no additional equipment to administer or interpret results. Using only a small sample of human tears, the simple, four-step Infl
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