Below is an excerpt from a press release
issued by OraSure describing the Hepatitis C Rapid Antibody Test
and its approval.
Technologies Receives FDA Approval for
OraQuick HCV Rapid Test, the First Rapid HCV Test
Approved for Sale in the U.S.
Pa. -- June 25, 2010 -- OraSure Technologies, Inc. (Nasdaq:OSUR)
announced today that its OraQuick Hepatitis C ("HCV")
Rapid Antibody Test has been approved by the U.S. Food and Drug
Administration ("FDA") for use in detecting HCV antibodies
in venous whole blood specimens, making it the first rapid HCV
test approved by the FDA for use in the United States.
"The OraQuick HCV test efficiently identifies previously
undiagnosed HCV infected individuals who are at risk,"
said Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University
of Miami School of Medicine. "We at the University of Miami
found this test to be user-friendly, practical and an important
tool for rapid HCV antibody detection."
"We believe that the OraQuick HCV Rapid Antibody Test,
with its simplicity and speed, will be a critical tool in identifying
more at risk individuals infected with hepatitis C in the U.S.,
and thus represents a significant market opportunity,"
said Douglas A. Michels, President and Chief Executive Officer
of OraSure Technologies. "Obtaining FDA approval of our
OraQuick HCV Rapid Antibody Test for venous whole blood represents
a major milestone for our Company."
OraQuick HCV is the only rapid, point-of-care test for the detection
of antibodies to the hepatitis C virus in venous whole blood
specimens that is approved by the FDA. The test, which utilizes
the OraQuick technology platform, provides results in 20 minutes.
The OraQuick HCV Rapid Antibody Test is the latest rapid test
manufactured by OraSure to receive FDA approval. OraSure had
previously received FDA approval for its OraQuick ADVANCE Rapid
HIV-1/2 Antibody Test for use with oral fluid, fingerstick and
venous whole blood and plasma samples.
In the U.S., there are an estimated 4.1 million Americans, or
1.6 percent of the population, that are or have been infected
with HCV. According to the Centers for Disease Control and Prevention
("CDC"), new infections in the U.S. are estimated
at approximately 20,000 per year. On a worldwide basis, there
are an estimated 180 million people who are chronically infected
with HCV, with an estimated 3 to 4 million individuals newly
infected each year.
According to the World Health Organization, most cases of HCV
infection are currently undiagnosed and up to 80 percent of
HCV-positive individuals show no signs or symptoms.
In December 2009, the Company received the CE mark for its OraQuick
HCV Rapid Antibody Test for use with oral fluid, whole blood,
serum and plasma specimens. The CE mark was required in order
to sell the product in the European Union.
As previously announced, OraSure has entered into agreements
with Merck & Co. (through its predecessor Schering Plough
Corporation) to collaborate on the development and promotion
of the OraQuick HCV test. Under the terms of these agreements,
the Company has been and will be reimbursed by Merck for a portion
of its costs to develop the test and obtain regulatory approvals.
Additionally, Merck will provide promotional support, including
detailing the test in the physicians' office market in those
countries in which the Company has obtained approval.
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
OraSure Technologies is the leading supplier of oral-fluid testing
solutions for drugs of abuse and for the detection of antibodies
For more information on the company, please go to www.orasure.com.
Klein and K Struble (Food and Drug Administration). FDA Approves
Rapid Test for Antibodies to Hepatitis C Virus. Press release.
June 25, 2010.
Technologies. OraSure Technologies Receives FDA Approval for
OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved
for Sale in the U.S. Press release. June 25, 2010.