Chembio Diagnostics Awarded UNICEF Contract to Supply Point-of-Care DPP® Zika Assays and DPP® Micro Readers
November 28 2017 - 8:50AM
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in
point-of-care (POC) diagnostic tests for infectious
diseases, today announced that it has been awarded a
conditional Long Term Arrangement (LTA) from UNICEF for purchases
of the Company’s DPP® Zika System, which is subject to Chembio
satisfying certain conditions. The UNICEF LTA, which is valid
through December 31, 2019, includes a firm purchase commitment of
$1.5 million and possible additional purchases of up to $3.4
million, for a potential total amount of up to $4.9 million. Under
terms of the LTA, purchases of the DPP® Zika System will begin
after Chembio has met the following conditions: receipt of World
Health Organization (WHO) Emergency Use Assessment and Listing
(EUAL), completion of clinical and analytical performance
evaluation, and a successful quality management system (QMS)
inspection.
In February 2017, UNICEF launched a Request for
Proposal (RFP) for the supply of Zika virus diagnostics for testing
at point-of-care through 2019. UNICEF'S RFP is supported by a $10
million Advance Purchase Commitment (APC) from USAID, which aims to
reduce demand uncertainty risks for manufacturers who invest in the
research and development of new products. UNICEF is collaborating
with partners, such as WHO and the Pan American Health Organization
(PAHO), to make commercially available POC diagnostics for Zika
virus.
Chembio’s DPP® Zika System, which includes the
DPP® Zika IgM/IgG Assay and DPP® Micro Reader, provides
quantitative results in 15 minutes from only 10μl of fingertip
blood. The DPP® Micro Reader is hand-held, easy to use, and can
reduce the risk of human error during test interpretation.
John Sperzel, Chembio’s Chief Executive Officer,
commented, “We are delighted that our DPP® Zika System
has been chosen by UNICEF and we look forward to working with
UNICEF, USAID, WHO, PAHO and other supporting organizations to
begin supplying our DPP® Zika Assay and DPP® Micro Reader
under this agreement. Given the limitations of laboratory-based
Zika tests, we believe our point-of-care DPP® Zika Assay and
DPP® Micro Reader will become essential tools in the battle
against the Zika virus.”
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops,
manufactures, licenses and markets rapid diagnostic tests in the
growing $8.0 billion POC testing market. The Company markets its
products directly and through third-party distributors under
the brand names: DPP®, STAT-PAK® and SURE CHECK®
Chembio has developed and patented
the DPP® technology platform, which offers significant
advantages over traditional POC lateral-flow technologies and
provides the Company with a significant pipeline of business
opportunities in the area of sexually transmitted disease, tropical
and fever disease, and technology collaborations.
Headquartered in Medford, NY, Chembio is
licensed by the U.S. Food and Drug Administration (FDA) as well as
the U.S. Department of Agriculture (USDA), and is certified for the
global market under the International Standards Organization (ISO)
directive 13485. Each of Chembio Diagnostic Systems, Inc. and
Chembio Diagnostics Malaysia Sdn Bhd is a wholly-owned subsidiary
of Chembio Diagnostics, Inc. For more information, please
visit: www.chembio.com.
Forward-Looking Statements
Statements contained herein that are not
historical facts may be forward-looking statements within the
meaning of the Securities Act of 1933, as amended.
Forward-looking statements include statements regarding the intent,
belief or current expectations of the Company and its
management. Such statements, which are estimates only,
reflect management's current views, are based on certain
assumptions, and involve risks and uncertainties. Actual
results, events, or performance may differ materially from the
above forward-looking statements due to a number of important
factors, and will be dependent upon a variety of factors,
including, but not limited to Chembio's ability to
obtain additional financing and to obtain regulatory approvals
in a timely manner, as well as the demand for Chembio's
products. Chembio undertakes no obligation to publicly update
these forward-looking statements to reflect events or circumstances
that occur after the date hereof or to reflect any change in
Chembio's expectations with regard to these forward-looking
statements or the occurrence of unanticipated events. Factors
that may impact Chembio's success are more fully disclosed in
Chembio's most recent public filings with the U.S. Securities and
Exchange Commission.
Contact:
Vida Strategic Partners (investor relations)Stephanie C.
Diaz(415) 675-7401sdiaz@vidasp.com
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Chembio Diagnostics (NASDAQ:CEMI)
Historical Stock Chart
From Apr 2023 to Apr 2024