Chembio Expands Exclusive Distribution Agreements with Isla Lab to Include Puerto Rico and U.S. Virgin Islands
September 23 2016 - 8:50AM
Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care
(POC) diagnostic tests for infectious diseases, today announced
that the Company has entered into an exclusive distribution
agreement with Isla Lab LLC that includes both Puerto Rico and the
U.S. Virgin Islands. Chembio recently announced that it had entered
into an exclusive distribution agreement with Isla Lab Caribbean
that included the 25 Caribbean nations. With today’s announcement,
Isla Lab becomes Chembio’s exclusive distribution partner
throughout the Caribbean region, including Puerto Rico and the U.S.
Virgin Islands.
The exclusive distribution agreements with Isla
Lab LLC include current products of Chembio that have met the
regulatory requirements established by the U.S. Food & Drug
Administration (FDA) that allow the products to be marketed and
sold in Puerto Rico and the U.S. Virgin Islands: DPP® HIV 1/2
Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay. The
agreements also provide for inclusion of Chembio products that may
obtain the required regulatory approvals in the future, such as
DPP® Zika IgM/IgG Assay, DPP® Chikungunya IgM/IgG Assay, DPP®
Dengue IgM/IgG Assay, DPP® Zika/Chikungunya/Dengue IgM/IgG
Combination Assay, DPP® HIV-Syphilis Assay, DPP® Syphilis Screen
& Confirm Assay, and DPP® Micro Reader.
John Sperzel, Chembio's CEO, commented, “Isla
Lab is the leading diagnostics distributor in the Caribbean region
and we are pleased to expand our exclusive distribution agreements
to include Puerto Rico and the U.S. Virgin Islands. We believe
Chembio’s U.S. FDA-approved point-of-care HIV Assays will become
important tools in Puerto Rico’s fight against HIV/AIDS, where over
20,000 people are living with HIV and approximately one in six
people are unaware of their positive HIV status. Nearly 20%
of the newly diagnosed HIV cases in Puerto Rico have advanced to
AIDS, a sign that current HIV testing methods are either not
sufficiently widespread or not sufficiently effective in
identifying acute or chronic HIV cases.
“Puerto Rico and the U.S. Virgin Islands are
experiencing widespread Zika virus transmission. Chembio is
actively engaged with the U.S. FDA, and we hope to obtain FDA
Emergency Use Authorization, which will allow the Company to
introduce our POC DPP® Zika IgM/IgG Assay and DPP® Micro Reader in
Puerto Rico and the U.S. Virgin Islands,” added Mr. Sperzel.
About Chembio Diagnostics
Chembio Diagnostics, Inc. develops,
manufactures, licenses and markets proprietary rapid diagnostic
tests in the growing $8.0 billion point-of-care testing
market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV
1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these
Chembio brand names, in the U.S. and internationally both directly
and through third-party distributors. The Company's SURE
CHECK® HIV 1/2 Assay previously has been exclusively sold in the
U.S. as Clearview® Complete HIV 1/2 Assay.
Chembio has developed a patented point-of-care
(POC) 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, 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.
About Isla Lab Products
Isla Lab Products, LLC was founded in 1977, in
San Juan, Puerto Rico and is a leader in the distribution of
innovative technology for clinical laboratories, hospitals and
other healthcare institutions. For more information, please visit:
www.islalab.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.
Contacts:
Chembio Diagnostics
Susan Norcott
(631) 924-1135, ext. 125
snorcott@chembio.com
Vida Strategic Partners (investor relations)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com
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