Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced it was awarded a $3.2 million contract from the
Centers for Disease Control and Prevention (CDC) for the
development and clinical validation of a rapid point-of-care (POC)
diagnostic test for syphilis.
Chembio will undertake to develop a syphilis
test and confirm assay based on its Dual Path Platform (DPP)
technology and proprietary DPP Micro Reader II. The assay will be
intended to simultaneously and separately detect treponemal and
nontreponemal IgM and IgG antibodies. The test should require only
10 µL of fingerstick blood, serum, or plasma and produce results in
under 20 minutes.
Chembio has previous experience in the field of
rapid syphilis diagnostics through its successful development,
validation, and commercialization of DPP HIV-Syphilis. The Chembio
DPP HIV-Syphilis Assay is a rapid serologic test for the detection
of antibodies to HIV and/or the causative agent of syphilis,
Treponema pallidum. Additionally, Chembio has worked to develop a
DPP Syphilis Screen and Confirm test, using a CDC licensed reagent
with improved liposomal preparation on the nontreponemal test
line.
“We are excited to continue expanding our core
sexually transmitted disease portfolio with the syphilis screen and
confirm assay,” commented Javan Esfandiari, Chembio’s Chief Science
and Technology Officer. “We look forward to developing a highly
sensitive and highly specific test that will potentially enable
physicians to diagnose and treat active syphilis in a timely
manner. Early and reliable diagnosis and timely treatment can
prevent transmission of syphilis as well as the development of
severe complications. We are honored to have been selected by the
CDC for this award.”
Syphilis infections continue to be a significant
health problem and are particularly threatening in high-risk groups
and in people who are pregnant, where congenital syphilis can
severely affect pregnancy outcome and infant morbidity. According
to the CDC, the rate of primary and secondary syphilis (the most
infectious stages of the disease) has increased almost every year
since the historic low in 2001–2002, increasing 25.4% during
2020–2021, according to preliminary data. The timely identification
and treatment of syphilis can decrease the transmission to others
and result in better patient outcomes.
Serologic tests are currently available in
clinical laboratories for the detection of active syphilis, which
require shipping samples to perform tests of moderate or high
complexity. There is no rapid point-of-care test currently
available to accomplish both screening and confirmation of active
syphilis. The development of such a test should allow for rapid
diagnosis of an active infection and timely patient treatment, thus
reducing the overall burden of syphilis in the U.S.
About the DPP Rapid Test
PlatformChembio’s proprietary DPP technology platform
provides high-quality, rapid diagnostic results in 15 to 20 minutes
using a small drop of blood from the fingertip or alternative
samples. Through advanced multiplexing, the DPP platform can detect
up to eight, distinct test results from a single patient sample,
delivering greater clinical value than other rapid tests. For
certain applications, Chembio’s easy-to-use, highly portable,
battery-operated DPP Micro Reader optical analyzer then reports
accurate results in approximately 15 seconds, making it well-suited
for decentralized testing where real-time results enable patients
to be clinically assessed while they are still on-site. Objective
results produced by the DPP Micro Reader reduce the possibility of
the types of human error that can be experienced in the visual
interpretations required by many rapid tests.
Chembio’s portfolio of DPP-based point-of-care
tests with FDA regulatory approvals include the DPP HIV-Syphilis
System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA
waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System
(EUA). Additionally, DPP-based tests have received regulatory
approvals from the World Health Organization, CE-Mark, ANVISA, and
other global organizations, where they aid in the detection and
diagnosis of several other critical diseases and conditions.
All DPP tests are developed and manufactured in
the United States and are the subject of a range of domestic and
global patents and patents pending.
About Chembio
DiagnosticsChembio is a leading diagnostics company
focused on developing and commercializing point-of-care tests used
to detect and diagnose infectious diseases, including sexually
transmitted disease, insect vector and tropical disease, COVID-19
and other viral and bacterial infections, enabling expedited
treatment. Coupled with Chembio’s extensive scientific expertise,
its novel DPP technology offers broad market applications beyond
infectious disease. Chembio’s products are sold globally, directly
and through distributors, to hospitals and clinics, physician
offices, clinical laboratories, public health organizations,
government agencies, and consumers. Learn more at
www.chembio.com.
Forward-Looking
StatementsCertain statements contained in the first,
second, fourth and sixth paragraphs above are not historical facts
and may be forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements regarding the intent, belief or
current expectations with respect to the opportunity, timing and
operational and financial success of Chembio’s ability to develop
and clinically validate a rapid point-of-care (POC) diagnostic test
for the screening and confirmation of active syphilis, and its
ability to develop such a syphilis screen and confirm assay that
will simultaneously and separately detect treponemal and
nontreponemal IgM and IgG antibodies, and require only 10 µL of
fingerstick blood, serum, or plasma and produce results in under 20
minutes. Such statements, which are expectations 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 forward-looking statements
due to a number of important factors, and will be dependent upon a
variety of factors, many of which may be outside the control of
Chembio, including, but not limited to, the following, any of which
could be exacerbated even further by the continuing COVID-19
outbreak in the United States and globally: the global need for a
rapid test to detect and diagnose active syphilis; the success of
Chembio’s research, development and commercialization efforts,
including Chembio’s ability to make the necessary investment with
respect to such efforts; Chembio’s ability to maintain existing,
and timely obtain additional, regulatory approvals; the potential
development of competing rapid POC tests for active syphilis;
Chembio’s retention of key personnel; transportation delays,
logistics disruptions and supply chain limitations; and changes
in U.S. trade policy. Chembio undertakes no obligation to
publicly update forward-looking statements in this release to
reflect events or circumstances that occur after the date hereof or
to reflect any change in Chembio’s expectations with regard to the
forward-looking statements or the occurrence of unanticipated
events. Factors that may impact Chembio’s success are more fully
disclosed in Chembio’s periodic public filings with the U.S.
Securities and Exchange Commission, including its Annual Report on
Form 10-K for the fiscal year ended December 31, 2021 and its
Quarterly Report on Form 10-Q for the quarterly periods ended March
31, 2022 and June 30, 2022, particularly under the heading “Risk
Factors.”
DPP is Chembio’s registered trademark, and the
Chembio logo is Chembio’s trademark. For convenience, these
trademarks appear in this release without ® or ™ symbols, but that
practice does not mean that Chembio will not assert, to the fullest
extent under applicable law, its rights to the trademarks.
Contact:Philip Taylor Gilmartin
Group415-937-5406investor@chembio.com
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