Chembio Diagnostics Announces CE Mark for DPP SARS-CoV-2 Antigen and IgM/IgG Test Systems
January 14 2021 - 7:00AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced the CE mark for the DPP SARS-CoV-2 Antigen and
IgM/IgG test systems, providing regulatory approval to register and
market both test systems in the European Union and other
geographies that accept the CE mark. The Company also announced
that it has entered into a distribution agreement with Luas
Diagnostics, which will commence system sales immediately while
serving as the exclusive commercial partner for all of Chembio’s
products in the United Kingdom and Ireland.
“Having the CE mark for both COVID-19 test systems
is indicative of the strong performance and reliability of the DPP
system. These tests can assist clinicians across Europe with the
diagnosis and management of patients and understanding virus
exposure levels in their communities through testing in a variety
of point-of-care settings,” stated Richard Eberly, Chembio’s
President and Chief Executive Officer. “Partnering with Luas
Diagnostics expands our global commercial footprint in the
important markets of the United Kingdom and Ireland. We are very
excited to offer our entire portfolio of products through this
highly respected and connected organization.”
The DPP SARS-CoV-2 Antigen test system utilizes a
DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical
analyzer and a minimally-invasive nasal swab to detect SARS-CoV-2
antigens in only 20 minutes. Rapid antigen tests are commonly used
in the diagnosis of respiratory pathogens.
The DPP SARS-CoV-2 IgM/IgG test system detects
antibodies to the Spike Receptor Binding Domain in the blood that
the body produces in response to a COVID-19 infection. Objective
results can be obtained within 15 minutes using finger stick,
venous whole blood, plasma, or serum samples, and Chembio’s
cost-effective, highly portable, DPP Micro Reader analyzers. The
DPP platform’s ability to provide objective results can aid
clinicians in avoiding the human interpretation errors associated
with visual readings of traditional lateral flow tests.
IgM and IgG antibody test results assist clinicians
in determining current or past exposure to the COVID-19 virus. The
results and data from the test can contribute to improved clinical
outcomes through management of individual patients, use as a
population surveillance tool, and potentially evaluation of immune
responses to vaccine administration.
Brendan Farrell, Chief Executive Officer of Luas Diagnostics,
commented, “We are excited to form a partnership with Chembio and
look forward to marketing and selling their range of rapid tests
into the United Kingdom and Irish markets. We see enormous
potential for Chembio’s rapid antigen and antibody products and DPP
multiplex solutions, where testing can be performed rapidly,
accurately, and with limited training.”
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.
About Luas Diagnostics:Luas Diagnostics is
based in Guildford, Surrey and is a UK registered private company,
which was founded in 2020. Using enzymes, Luas Diagnostics has
developed a new class of sensors that generate electric current
upon encountering their molecular target, allowing the development
of biomarker assays that are an order of magnitude faster, more
versatile, and cheaper to build than current systems in the market.
Because Luas Diagnostics’ diagnostic tests do not require
preparation, washing steps, or complex reading mechanisms, the
tests can be miniaturized and coupled to a smartphone via Bluetooth
for easy readout and uploading of data to repositories in the
cloud.
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 TaylorGilmartin
Group(415) 937-5406investor@chembio.com
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