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: , 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.
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