OraSure Awarded Up to $16.6 Million to Advance Rapid Zika Tests
August 23 2016 - 4:00PM
OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point of care
diagnostic tests and specimen collection devices, announced today
that it has been awarded a contract for up to $16.6 million in
total funding from the U.S. Department of Health and Human Services
(HHS) Office of the Assistant Secretary for Preparedness and
Response’s Biomedical Advanced Research and Development Authority
(BARDA) to advance the Company’s rapid Zika tests.
The six-year, multi-phased contract includes an initial
commitment of $7.0 million and options for up to an additional $9.6
million to fund the evaluation of additional product enhancements,
and clinical and regulatory activities. The Company is expected to
provide an update on guidance and timing during its next quarterly
earnings call in November.
The rapid Zika tests utilize the Company’s OraQuick® technology
platform, which is the same proven technology used in the Company’s
rapid HIV, HCV and Ebola test kits. Although there are currently
molecular tests available for Zika, the Company believes these
tests have limited utility, because of the short window of time
when viral RNA can be detected in patients. Because anti-Zika
antibodies appear in the body soon after infection and are present
in the body for longer periods than the virus, the Company believes
there is a significant need and utility for a rapid Zika antibody
test. In addition, currently available tests are conducted in
a laboratory and the availability of a rapid test will minimize
turnaround time of results for the healthcare provider and
patient.
"We believe the availability of an accurate rapid Zika antibody
test will be a valuable tool to address current and potential
future outbreaks,” said Douglas A. Michels, President and Chief
Executive Officer of OraSure Technologies. “We are grateful to
BARDA for making this funding available as it will enable us to
complete clinical and other activities required to obtain
regulatory approvals for this product.”
Earlier in the year, OraSure announced that it had engaged in a
development program for rapid Zika assays on the OraQuick platform
and that the Company was actively pursuing external funding to
advance this program.
OraSure has a highly successful track record for developing and
commercializing point-of-care tests that address critical disease
states. Most recently, with the support of up to $10.4 million from
BARDA, the Company developed the OraQuick Ebola Rapid Antigen Test
which received U.S. Food and Drug Administration (FDA) Emergency
Use Authorization for the use of the test with fingerstick blood
and cadaveric oral fluid samples. The Company also developed the
only FDA approved rapid antibody test for hepatitis C, the
OraQuick® HCV Rapid Antibody Test, and the first FDA approved rapid
test for HIV, the OraQuick ADVANCE® HIV-1/2 Antibody Test.
The Company has also developed the first and only HIV self test
approved by the FDA for use by consumers, the OraQuick® In-Home HIV
Test.
The Zika and Ebola projects have been funded in whole or in part
with Federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority,
under Contract No. HHSO100201600028C and Contract No.
HHSO100201500009C, respectively.
About OraSure TechnologiesOraSure 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.
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
Ron Ticho
SVP, Corporate Communications
484-353-1575
media@orasure.com
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