OraSure Technologies, Inc. announced today the impending launch of the OraSure QuickFlu™ Rapid Flu A+B Test, a U.S. Food and Drug and Administration ("FDA") approved in vitro rapid qualitative test for the detection of influenza (flu) type A and type B, including H1N1 viral infections. The test specimen is collected with a nasal swab, nasopharyngeal swab, or nasal aspirate/wash and results are available in as little as 10 minutes.
The OraSure QuickFlu™ test is intended for use as an aid in the rapid differential diagnosis of influenza. OraSure QuickFlu™ covers a broad range of influenza subtypes, including 2009 H1N1 with proven clinical detection spanning three flu seasons from 2007 through 2009. The kit incorporates a nylon-flocked swab that optimizes sample collection and release, resulting in superior performance.
The OraSure QuickFlu™ test is highly accurate across all specimen types based on standard culture confirmation with demonstrated sensitivity for influenza type A at 90% or greater – across sample types. Additionally, in clinical studies, a significant number of culture negative samples that were OraSure QuickFlu positive were determined to be true positives by PCR (polymerase chain reaction) testing.
"Greater sensitivity and high correlation with detection of virus by PCR means that more individuals who have the flu can be accurately diagnosed so they can receive the appropriate care," said Dr. Stephen Lee, Executive Vice President and Chief Science Officer of OraSure Technologies.
The Company expects to have product available to sell directly into hospital, public health and government markets by February. Application for CLIA Waiver has been submitted to the FDA. OraSure QuickFlu™ will be manufactured for OraSure and supplied under an agreement with Princeton BioMeditech Corporation.
"Hundreds of thousands of individuals are hospitalized each year from flu complications. This test has been shown to accurately detect a wide spectrum of recent flu strains," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The OraSure QuickFlu™ test, with its ease-of-use and high accuracy across all specimen types, will be a critical tool in accurately identifying more people with the flu. It is responsive to the needs of our customers and an ideal complement to our current portfolio of rapid infectious disease point-of-care products."
The flu is a contagious respiratory illness caused by influenza viruses. Complications of the flu can include bacterial pneumonia, ear infections, sinus infections, dehydration, and worsening of chronic medical conditions, such as congestive heart failure, asthma, or diabetes. According to the Centers for Disease Control ("CDC"), on average in the U.S. each year, 5% to 20% of the population gets the flu; more than 200,000 people are hospitalized from flu complications each year.
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