OraSure Technologies to Launch OraSure QuickFlu(TM) Rapid Flu A+B Test
11 Gennaio 2011 - 12:00PM
OraSure Technologies, Inc. (Nasdaq:OSUR) 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.
About Princeton BioMeditech Corporation
Princeton BioMeditech Corporation, Monmouth Junction, NJ, is a
recognized world leader in rapid, point-of-care diagnostics
development, manufacturing and marketing. The company markets its
products globally, including rapid diagnostic tests for fertility,
infectious diseases, drugs of abuse, and cardiac and tumor markers.
For more information on the Company, please go to www.pbmc.com
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral
fluid specimen collection devices using proprietary oral fluid
technologies, diagnostic products including immunoassays and other
in vitro diagnostic tests, and other medical devices. These
products are sold in the United States as well as internationally
to various clinical laboratories, hospitals, clinics,
community-based organizations and other public health
organizations, distributors, government agencies, physicians'
offices, and commercial and industrial entities. For more
information on the Company, please go to www.orasure.com.
The OraSure Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6440
CONTACT: Investor Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
investorinfo@orasure.com
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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