Full Press Release Details
| Investor Contact: | Media Contact: | |
| Ronald H. Spair | Jennifer Moritz | |
| Chief Financial Officer | Zer0 to 5ive for OraSure Technologies | |
| 610-882-1820 | 917-748-4006 | |
| investorinfo@orasure.com | jmoritz@0to5.com |
OraSure Technologies Receives CLIA Waiver for OraQuick HCV Rapid Test
BETHLEHEM, PA November 29, 2011 OraSure Technologies, Inc. (NASDAQ:OSUR) announced today that the U.S. Food and Drug Administration ( FDA ) has granted a waiver under
the Clinical Laboratory Improvement Amendments of 1988 ( CLIA ) for its OraQuick HCV Rapid Antibody
Test for use with fingerstick whole blood and venous whole blood specimens.
The OraQuick HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the
hepatitis C virus ( HCV ). The test, which utilizes the OraQuick technology platform, provides
results in 20 minutes. With this waiver, the OraQuick HCV test now can be used by more than 180,000 sites in
the United States to test persons who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now extend to facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations and physician
Today, more than 4 million Americans are infected with hepatitis C and the vast majority do not know it, said
Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high
percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic.
A CLIA waiver for our OraQuick HCV test represents a
critical milestone in our quest to make the test available to the widest possible range of at risk individuals in the U.S., said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. The CLIA waiver will
enable healthcare providers, those on the front lines of fighting this devastating disease, to use this simple and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed and
As previously announced, OraSure has entered into agreements with Merck & Co. (NYSE:MRK) to
collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will
provide detailing and other promotional support for the test in the physicians office markets in the United States and internationally. The approval of the CLIA waiver will now enable physicians to utilize the test in their office settings.
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 addition, through its wholly-owned subsidiary, DNA Genotek
Inc., the Company also 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.