OraSure Technologies Provides Update on OraQuick Ebola Rapid Antigen Test Business
September 29 2015 - 06:00AM
OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care
diagnostic tests and specimen collection devices, announced today
that it has made significant progress regarding the
commercialization of its OraQuick® Ebola Rapid Antigen Test.
The Company announced that the Biomedical Advanced Research
Development Authority (BARDA) of the U.S. Department of Health and
Human Services (HHS) has exercised an option to provide $7.2
million in additional funding for the Company's OraQuick® Ebola
Rapid Antigen Test. This funding will be used primarily for
clinical and regulatory activities required to request U.S. Food
and Drug Administration (FDA) 510(k) clearance for this product.
This option is part of the $10.4 million funding contract (base
plus options) between OraSure and BARDA that was previously
announced in June 2015.
The Company also announced today that HHS' Centers for Disease
Control and Prevention (CDC) will purchase approximately $1.5
million of the Company's OraQuick® Ebola Rapid Antigen Test. The
CDC purchase is expected to be fulfilled by the end of 2015. CDC is
purchasing the OraQuick® Ebola Rapid Antigen Tests for field
testing in West Africa. This is the second such purchase of this
product for field testing made by CDC.
"The populations affected by Ebola are large, and current
testing methods severely limit testing capacity. As such, we
believe that the OraQuick® Rapid Ebola Test will be an important
tool in containing and controlling the Ebola outbreak," said
Douglas A. Michels, President and Chief Executive Officer of
OraSure Technologies. "We are grateful to both the CDC and BARDA
for their continued support."
The OraQuick® Ebola Rapid Antigen Test utilizes the same proven
technology platform used in the Company's rapid HIV and HCV test
kits. The OraQuick® Ebola Test received Emergency Use Authorization
(EUA) from the FDA in July 2015 and is designed to detect viral
antigens in fingerstick and venous whole blood from patients
presenting with signs and symptoms of Ebola infection in
conjunction with epidemiological risk factors. Positive (reactive)
results may be read as soon as they appear and have been observed
as early as 4 minutes. Negative (non-reactive) results have to be
read at 30 minutes. The test can be used at ambient temperatures
(up to 40°C / 104°F), is easy to use with a simple visual read, and
does not require instrumentation.
This project has been funded in whole or in part with Federal
funds from BARDA, part of the U.S. Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; under Contract No. HHSO100201500009C.
Critical reagents in the OraQuick® Ebola Rapid Antigen Test are
being supplied by the Viral Hemorrhagic Fever Consortium (VHFC;
www.vhfc.org) and the Biological Defense Research Directorate at
the United States Navy Medical Research Center (NMRC). The VHFC
reagents were developed with the support of the National Institute
of Allergy and Infectious Diseases of the National Institutes of
Health ("NIH/NIAID"). VHFC members, Autoimmune Technologies LLC,
and Zalgen Labs LLC manufacture the critical reagents.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture
and distribution of point of care diagnostic and collection devices
and other technologies designed to detect or diagnose critical
medical conditions. Its first-to-market, innovative products
include rapid tests for the detection of antibodies to HIV and HCV
on the OraQuick® platform, oral fluid sample collection,
stabilization and preparation products for molecular diagnostic
applications, and oral fluid laboratory tests for detecting various
drugs of abuse. 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, commercial and industrial entities and
consumers. 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.
CONTACT: Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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