Chembio Diagnostics Receives FDA Approval for DPP HIV-Syphilis System
October 02 2020 - 7:26AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced that the U.S. Food and Drug Administration (FDA)
has approved the Premarket Approval (PMA) application for the DPP
HIV-Syphilis System. The system includes the DPP HIV-Syphilis
assay, a multiplex single-use test, and the DPP Micro Reader
optical analyzer, and is being offered in the United States
immediately.
“The multiplex DPP HIV-Syphilis System represents a
significant step forward in rapid testing for sexually transmitted
diseases. This differentiated test provides clinicians with
actionable information to improve patient care in critical areas,
including co-infection and mother to child transmission,” said
Richard Eberly, Chembio’s President and Chief Executive Officer.
“We would like to thank the FDA for their effort throughout the
approval process. This expansion of our product portfolio aligns
directly with our diversification into high-value testing areas in
the United States. Under the PMA, the DPP HIV-Syphilis System is
approved for use by trained professionals in point-of-care (POC)
and laboratory settings to aid in the diagnosis of HIV and syphilis
infections. Activities to pursue a CLIA Waiver are ongoing.”
Co-infection rates of HIV and syphilis are on the
rise and, according to the U.S. Centers for Disease Control and
Prevention (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 has increased by
185.3% from 2014 to 2018, consistent with the 165.4% increase in
active syphilis infections among reproductive-aged women during the
same period.
Congenital syphilis is a preventable disease that
could be significantly reduced through effective prenatal testing
and treatment of infected pregnant women. Chembio’s DPP
HIV-Syphilis System assists clinicians in diagnosing HIV or
syphilis while patients are still at a POC setting.
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, and 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 is a multiplex,
single-use, 15-minute test, which is designed, in combination with
the 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 of whole blood, venous whole blood, or plasma. The
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 Chembio DiagnosticsChembio is a leading
point-of-care diagnostics company focused on detecting and
diagnosing infectious diseases, including COVID-19, sexually
transmitted disease, and fever and tropical disease. The company’s
proprietary DPP technology platform, which uses a small drop of
blood from the fingertip or alternative sample types, provides
high-quality, cost-effective results in approximately 15 minutes.
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
StatementsStatements contained in the second paragraph of
this release that are not historical facts may be forward-looking
statements within the meaning of the Securities Act of 1933.
Forward-looking statements include statements regarding the intent,
belief or current expectations of Chembio and its management with
respect to the marketing and sale of the DPP HIV-Syphilis System.
Such statements 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: potential customers in the United States may not adopt
the DPP HIV-Syphilis System to the extent expected by Chembio or
Chembio may otherwise be unable to successfully and timely
manufacture and commercialize the DPP HIV-Syphilis System; Chembio
may not succeed in obtaining a CLIA Waiver with respect to the DPP
HIV-Syphilis System; and Chembio may not be able to compete
successfully with other companies that have developed, or develop
in the future, detection systems that compete with the DPP
HIV-Syphilis System, some of which companies have substantially
greater resources than Chembio. 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 public filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K for
the fiscal year ended December 31, 2019 and its subsequent
Quarterly Reports on Form 10-Q, particularly under the heading
“Risk Factors.” Readers should interpret many of the risks
identified in these reports as being heightened as a result of the
ongoing and numerous adverse impacts of the COVID-19 pandemic.
DPP is Chembio’s registered trademark. For convenience, this
trademark appears in this release without ® symbols, but that
practice does not mean that Chembio will not assert, to the fullest
extent under applicable law, its rights to the trademark.
Contact: Philip TaylorGilmartin
Group(415) 937-5406investor@chembio.com
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