OraSure Technologies Praises New Routine HIV Screening Recommendations by U.S. Preventive Services Task Force
22 11월 2012 - 2:15AM
OraSure Technologies, Inc. (Nasdaq:OSUR) announced today its
support for the draft recommendations issued yesterday by the U.S.
Preventive Services Task Force (USPSTF), calling for routine HIV
testing for all people ages 15 to 65.
The new recommendations, entitled Screening for HIV: U.S.
Preventive Services Task Force Recommendation Statement, are a
significant expansion of the USPSTF's previous recommendation of
screening only those at risk for HIV.
The USPSTF is an independent group of national experts in
prevention and evidence-based medicine that works to improve the
health of all Americans by making evidence-based recommendations
about clinical preventive services such as screenings, counseling
services, and preventive medications. USPSTF recommendations have
formed the basis of the clinical standards for many professional
societies, health organizations, and medical quality review
groups.
"We applaud the new U.S. Preventive Services Task Force
recommendations, which will help increase access and reduce
barriers to HIV testing as a regular part of medical care," said
Douglas A. Michels, President and Chief Executive Officer of
OraSure Technologies. "As a result of the recommendations, we
believe more individuals will get tested and learn their HIV
status, and we expect that both our OraQuick® ADVANCE Rapid HIV
test and our OraQuick® In-Home HIV test will serve important roles
in achieving this goal."
A number of published studies and reports indicate that rapid
HIV testing has a significant beneficial impact in clinical care
settings, including data that shows that a significantly higher
number of people receive their HIV test results with rapid testing
than with laboratory-based testing. Most recently, according to
data released in September 2012 by the Centers for Disease Control
and Prevention (CDC), HIV Testing at CDC-Funded Sites, United
States, Puerto Rico, and the U.S. Virgin Islands, 2010, the
percentage of all testing events that were followed up with receipt
of HIV test results was higher among testing events that included
rapid tests (98%) than testing events that did not include rapid
tests (47%). For persons with newly identified confirmed HIV, the
percentage of testing events that were followed up with receipt of
HIV test results was also shown to be higher among testing events
that included rapid tests (99.6%) than testing events that did not
include rapid tests (81%). Rapid testing provides results at the
point of care, enabling patients to learn their status in a single
visit, and allows HIV positive patients to be connected to care
immediately.
Despite testing options that have been available for years, the
CDC estimates that approximately 1.2 million people in the U.S.
have HIV and approximately 240,000 of them are unaware of their
status. Those who do not know they are HIV positive are
disproportionately responsible for a majority of the 50,000 new HIV
infections that occur each year. The CDC recommends routine HIV
screening for all people ages 13 to 64, with more frequent testing
for people at higher risk.
The USPSTF draft recommendations are based on a study of the
most recent evidence on the risks and benefits of HIV testing
published in the Annals of Internal Medicine. The recommendations
will be available for a 30-day public comment period.
OraQuick ADVANCE® is the only FDA-approved and CLIA-waived rapid
point-of-care test that can detect antibodies to both HIV-1 and
HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture
whole blood or plasma specimens. As the market leader in rapid HIV
testing, OraQuick ADVANCE® is used extensively throughout the
country, with more than 25 million units sold in public health
settings, hospitals, community-based organizations, and physician
offices where HIV testing is conducted.
OraSure also recently announced the launch of its OraQuick®
In-Home HIV Test, the first rapid infectious disease test ever to
be made available directly to consumers for in-home use. The
OraQuick® In-Home HIV Test detects antibodies to both HIV-1 and
HIV-2 with an oral swab, providing a confidential in-home testing
option with results in as little as 20 minutes. The in-home test is
an over-the-counter version of the OraQuick ADVANCE® test. The
OraQuick® In-Home HIV Test is now available in retail stores
nationwide, through select retailers online and on the Company's
product website at www.OraQuick.com.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture
and distribution of oral fluid diagnostic and collection devices
and other technologies designed to detect or diagnose critical
medical conditions. Its innovative products include rapid tests for
the detection of antibodies to HIV and HCV at the point of care and
testing solutions for detecting various drugs of abuse. In July
2012, the Company received approval from the U.S. Food and Drug
Administration for the Company's OraQuick® In-Home HIV Test for
sale directly to consumers in the over-the-counter (OTC) market for
ages 17 and above – making it the first and only rapid OTC HIV test
approved in the U.S. In addition, the Company is a leading provider
of oral fluid sample collection, stabilization and preparation
products for molecular diagnostic applications. OraSure's portfolio
of products is sold globally to various clinical laboratories,
hospitals, clinics, community-based organizations and other public
health organizations, research and academic institutions,
distributors, government agencies, physicians' offices, and
commercial and industrial entities. The Company's products enable
healthcare providers to deliver critical information to patients,
empowering them to make decisions to improve and protect their
health.
For more information on OraSure Technologies, please visit
www.orasure.com.
The OraSure Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6440
CONTACT: Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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