OraSure Technologies Praises New Routine HIV Screening Recommendations by U.S.
Preventive Services Task Force
New Recommendations Advocate HIV Screening as Part of Routine Medical Care for
All People Ages 15 to 65
BETHLEHEM, Pa., Nov. 21, 2012 (GLOBE NEWSWIRE) -- 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
"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
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
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