Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced it is evaluating the potential to develop a
monkeypox rapid point-of-care (POC) test. Chembio is exploring the
technical requirements for test development leveraging its multiple
technology platforms, DPP, SURE CHECK, and STAT PAK, along with
funding partners and the broader market opportunity.
“We are in dialogue with leading health
organizations at the federal and state level to evaluate the need
for a rapid test to detect and diagnose monkeypox. We are assessing
the market needs, timing, regulatory pathway and investment
required to develop a test,” said Richard Eberly, Chembio’s
President and Chief Executive Officer. “Current tests available for
monkeypox are PCR based, and given our history of developing rapid
POC tests for infectious disease outbreaks, we believe we may be
positioned to leverage our technology to provide a differentiated
rapid solution. Based on our findings we will determine if this is
a viable future opportunity for Chembio.”
Monkeypox is a rare disease caused by infection
with the monkeypox virus. Monkeypox virus is part of the same
family of viruses as variola virus, the virus that causes smallpox
with symptoms similar to smallpox symptoms, but milder, and rarely
fatal. Monkeypox can spread from person to person through direct
contact with the infectious rash, scabs, or body fluids. It also
can be spread by respiratory secretions during prolonged,
face-to-face contact, or during intimate physical contact. There
are now over 11,000 total confirmed monkeypox cases in the United
States.
Chembio has a track record of delivering testing
solutions for three recent infectious disease outbreaks with the
expedited development rapid point-of-care tests. This includes the
rapid development of a Zika product for the U.S. market, when the
Zika outbreak was impacting the United States in 2017. The company
also developed a DPP Ebola test to help with the outbreak with
Ebola in 2018. This was followed by the development of COVID tests
when the pandemic hit the U.S. in 2020. Additionally, Chembio has
developed rapid point-of-care DPP diagnostic tests for HIV 1/2 and
Syphilis with the introduction of STAT PAK and SURE CHECK.
Currently, the FDA has cleared one test to
detect monkeypox, offered through the U.S. Centers for Disease
Control and Prevention (CDC) as a lab developed test (LDT). The
test utilizes a swab sample from a monkeypox lesion, creating the
need for earlier detection to limit the spread of the disease and
expedite treatment.
About the DPP Rapid Test
Platform
Chembio’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 Diagnostics
Chembio 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 Statements
Certain statements contained in the first and
second 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 desire and ability
to research, develop and manufacture a rapid POC test to detect
monkeypox. 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 monkeypox; 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 monkeypox; 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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