Chembio Launches U.S. Sales and Marketing Initiative
Chembio Now Marketing HIV 1/2 STAT-PAK(R) and DPP(R) HIV 1/2 Assays
MEDFORD, N.Y., June 4, 2014 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc.
(Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests and
technology, today announced the launch of the Company's U.S. sales and
marketing effort. Effective today, the Company has initiated sales of its
Chembio HIV 1/2 STAT-PAK^® Assay and its corresponding HIV Rapid Test Control
Pack, as well as the Company's proprietary DPP^® HIV 1/2 Assay and
corresponding DPP^® HIV 1/2 Control Pack in the United States. The Company has
also assumed all customer and technical support for its Chembio-branded
products in the U.S.
The Chembio HIV 1/2 STAT-PAK^® Assay is FDA-approved and CLIA-waived and has
been one of the leading diagnostics in the fight against HIV/AIDS since its
market introduction in 2006. The ease of use, small (5 µL) specimen
requirement, rapid and reliable results, long shelf life and room temperature
storage make it uniquely suited for clinical and outreach settings, allowing
immediate patient counseling and referral.
Chembio's DPP^® HIV 1/2 Assay detects HIV antibodies in oral fluid or blood
and uses our patented Dual Path Platform technology which offers excellent
sensitivity and specificity. Its unique SampleTainer^® specimen collection
bottle is a safe, closed system for collecting potentially infectious samples.
The Chembio DPP^® HIV 1/2 Assay is FDA-approved and initial marketing of this
product will be directed to CLIA moderately complex testing sites. We are
working with the FDA concerning CLIA waiver for this product, and are
submitting additional information needed for the FDA's further review of the
"We believe that Chembio has established a world-class sales and marketing
organization," stated John Sperzel, Chembio's CEO. "I'm confident that our
U.S. program will bring us closer to our customers and enable us to strengthen
our position in the market. Our HIV 1/2 STAT-PAK^® Assay is one of the most
reliable and respected HIV diagnostics in the U.S., and we hope to leverage
our reputation for quality and innovation as we introduce our proprietary Dual
Path Platform (DPP^®) diagnostics to the market."
The Chembio HIV 1/2 STAT-PAK^® Assay, which was previously marketed in the
U.S. exclusively as Clearview^® HIV 1/2 STAT-PAK^® Assay, has not undergone
any changes in format or formulation. Both the HIV 1/2 STAT-PAK^® Assay and
the DPP^® HIV 1/2 Assay will continue to be manufactured exclusively at
Chembio's FDA-registered, cGMP compliant and ISO 13485 certified facility in
Medford, NY. For more information on any of the Chembio-branded products
including the Chembio HIV 1/2 STAT-PAK^® Assay, please contact our customer
service team at 1.844.CHEMBIO or visit us at: www.chembio.com.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops, manufactures, licenses and markets
proprietary rapid diagnostic tests in the growing $10 billion point-of-care
testing market. Chembio markets its HIV 1/2 STAT-PAK^® Assay to physicians and
testing sites in the U.S. and through select distributor channel partners. The
Company's SURE CHECK^® HIV 1/2 Assay is marketed exclusively in the U.S. by
Alere, Inc. Chembio also markets its HIV 1/2 STAT-PAK^® and SURE CHECK^® HIV
1/2 Assays internationally through distributors. Chembio has developed a
patented point-of-care test platform technology, the Dual Path Platform
(DPP^®) technology, which has significant advantages over lateral-flow
technologies. This technology is providing Chembio with a significant pipeline
of business opportunities for the development and manufacture of new products.
Headquartered in Medford, NY, with approximately 200 employees, 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. Chembio
Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics,
Inc. For more information, please visit: www.chembio.com.
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: Chembio Diagnostics
(631) 924-1135, ext. 125
Vida Strategic Partners (investor relations)
Stephanie C. Diaz
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