Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostics company focused on infectious diseases,
today announced receipt of a Clinical Laboratory Improvement
Amendments (CLIA) waiver from the U.S. Food and Drug Administration
(FDA) for the DPP HIV-Syphilis System.
“The DPP HIV-Syphilis System represents an
exciting advancement in rapid testing for sexually transmitted
infections. We are excited that the 200,000+ CLIA waived
point-of-care testing sites in the U.S. now have access to the DPP
HIV-Syphilis System where its use can help save lives and minimize
the spread of both HIV and syphilis,” said Richard L. Eberly,
Chembio’s President and Chief Executive Officer. “Rapid HIV and
syphilis combination testing is now even more important to
community health as the U.S. Centers for Disease Control and
Prevention’s (CDC) most recent sexually transmitted disease (STD)
surveillance data reports that STDs in the U.S. have reached
all-time highs for the sixth consecutive year. Most importantly,
the DPP HIV-Syphilis System offers actionable information to better
manage two of the most critical threats posed by syphilis
infections: the potentially lethal mother to child transmission and
the increased risk of contracting HIV.”
Mr. Eberly continued, “We would like to thank
the FDA for their efforts in granting the CLIA waiver for the first
point-of-care test to aid in the diagnosis of both HIV and syphilis
from a single patient sample. We believe this is a significant step
forward in the management of HIV and syphilis infections.”
Russell Rooms, DNP, APRN-C of Diversity Family
Health, a private practice clinic specializing in the care of the
LGBTQ+ community, further added, “The Chembio DPP HIV-Syphilis test
has provided us with the ability to quickly screen patients for HIV
and syphilis and allows us to be able to start treatment faster and
differentiate between other disease processes. This means that we
can better prevent the spread of these infections.”
Co-infection rates of HIV and syphilis are on the
rise and, according to the CDC, individuals with an active syphilis
infection have an estimated two- to five-fold increased risk of
contracting HIV if exposed to that virus. The CDC has also reported
that untreated syphilis in pregnant women who acquired the disease
during the four years before delivery can lead to infection of the
fetus in up to 80% of cases and may result in stillbirth or infant
death in up to 40% of cases. Congenital syphilis is a preventable
disease that could be significantly reduced through effective
prenatal testing of women of childbearing age and treatment of
infected pregnant women.
According to the U.S. Department of Health &
Human Services, one in eight people living with HIV in the United
States are unaware of their infection. Improving access to HIV
testing can help more people learn their status so they can be
connected to care and treatment. The CDC recommends that
individuals at higher risk of HIV infection be tested at least
annually.
Chembio’s DPP HIV-Syphilis System assists
clinicians in diagnosing both HIV and syphilis while patients are
still under care at the testing location. The DPP HIV-Syphilis
System is a multiplex, single-use, 15-minute test that is designed,
in combination with Chembio’s Micro Reader analyzer, to
simultaneously detect antibodies to HIV types 1 and 2 and Treponema
pallidum, the bacteria that causes syphilis. The test uses a small,
10-microliter sample of fingerstick whole blood, venous whole
blood, or plasma. The DPP HIV-Syphilis System is highly sensitive
and specific, has a built-in procedural control, can be stored at
room temperature, and has a 24-month shelf life.
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,
enabling 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 this press release 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 distribution and sale of
Chembio’s DPP HIV-Syphilis System, and the availability, timing,
functionality and continued regulatory approval of the test system.
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,
including, but not limited to, the following: the ability of
Chembio to timely maintain regulatory approvals for such test
system, which approvals are subject to processes that can change
recurringly without notice. 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 year ended December 31, 2021, its Quarterly
Reports on Form 10-Q for the quarterly periods ended March 31,
2022, June 30, 2022 and September 30, 2022, and in subsequent
filings, 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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