Chembio Diagnostics Receives ANVISA Approval for DPP SARS-CoV-2 Antigen Test System in Brazil
November 13 2020 - 4:40PM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced that its subsidiary Chembio Diagnostics Brazil
Ltda. has received regulatory approval from Agência Nacional de
Vigilância Sanitária (ANVISA) to market the DPP SARS-CoV-2 Antigen
test system in Brazil.
The DPP SARS-CoV-2 Antigen test system is designed to detect
SARS-CoV-2 antigens in only 20 minutes. The detection of specific
SARS-CoV-2 viral antigens implies a current infection by the virus
responsible for COVID-19 cases. The DPP SARS-CoV-2 Antigen test
system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP
Micro Reader 1 or DPP Micro Reader 2 analyzer, and a minimally
invasive nasal swab.
Clinical trial data demonstrates sensitivity of 96.0% at zero to
six days from the onset of symptoms and specificity of 98.7% on
symptomatic population as compared to PCR tests.
“We are grateful for the rapid review and approval
of our DPP SARS-CoV-2 Antigen assay by ANVISA. The exceptional
performance of this assay highlights again the value and
flexibility of our DPP technology,” stated Javan Esfandiari,
Chembio’s Vice President and Chief Science & Technology
Officer. “We believe helping people understand their infection
status has shown to be one of the most effective methods for
controlling the spread of COVID-19. Enabling patients and providers
to know this information at the point-of-care in 20 minutes can
help further reduce the risk of virus transmission and improve
patient outcomes. We are very proud to offer this test in Brazil
and assist in efforts to manage the global pandemic.”
Chembio Diagnostics Brazil, formerly Orangelife
Comercio e Industria Ltda., is Chembio’s Brazilian commercial
subsidiary that Chembio acquired in November 2019. Offering leading
point-of-care tests to Brazilian state, private, and pharmacy
markets, Chembio Diagnostics Brazil also provides local support to
the Company’s long-time partner Bio-Manguinhos.
“Combined with ANVISA’s prior Approval for
Emergency Use of the DPP COVID-19 IgM/IgG assay, we are now able to
offer the Brazilian healthcare system tests that detect active
infections and provide antibody status that both run on the same
Micro Reader analyzers. Our test systems are rapid, accurate, and
ideal for decentralized testing which can help expand access to
testing across communities,” stated Charles Caso, Chembio’s Vice
President, Sales and Marketing. “We view Brazil as one of the most
attractive infectious disease testing markets in the world, and we
plan to expand the commercial team at Chembio Diagnostics Brazil to
leverage our growing portfolio of approved tests in the
country.”
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, Agência
Nacional de Vigilância Sanitária (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 point-of-care diagnostics company focused on detecting
and diagnosing infectious diseases, including COVID-19, sexually
transmitted disease, and fever and tropical disease. 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.
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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