Chembio Diagnostics Receives FDA 510(k) Clearance for DPP Zika IgM System
June 08 2020 - 8:00AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading
point-of-care diagnostic company focused on infectious diseases,
today announced it has received U.S. Food and Drug Administration
(FDA) 510(k) clearance to market the DPP Zika IgM System.
The Chembio DPP Zika IgM System is intended for the
presumptive qualitative detection of Zika virus IgM antibodies in
human serum, potassium-EDTA plasma, potassium-EDTA venous whole
blood, or fingerstick whole blood specimens, collected from
individuals meeting the CDC Zika virus clinical criteria (e.g., a
history of clinical signs and symptoms associated with Zika virus
infection) and/or CDC Zika virus epidemiological criteria (e.g.,
history of residence in or travel to a geographic region with
active Zika transmission at the time of travel, or other
epidemiological criteria for which Zika virus testing may be
indicated). Additionally, this clearance represents the initial
U.S. regulatory approval for the DPP Micro Reader. The DPP Micro
Reader is a handheld portable analyzer that produces numerical
results from Chembio DPP tests and is compatible with the entire
portfolio of Chembio DPP tests. The DPP Zika System, which includes
the DPP Zika IgM Assay and DPP Micro Reader, detects IgM antibodies
from a 10uL fingerstick blood sample and provides numerical results
after 15 minutes of sample incubation and 15 seconds of test read
time.
“Our DPP Zika System offers superior accuracy,
rapid detection and the ease of use Chembio’s DPP point-of-care
technology is known for. We are thankful for the support of BARDA
in this development program and for their recognition of the value
of our technology,” stated Rick Eberly, Chembio’s President and
Chief Executive Officer. “FDA clearance for our DPP Zika System
represents two significant execution milestones, the initial
clearance for our DPP Micro Reader in the U.S. and expansion of our
testing menu. We appreciate the critical support and guidance
provided by the FDA first through Emergency Use Authorization and
then through 510(k) clearance which allowed us to deliver tests to
the market quickly and continuously during a time of need.”
Funds used to develop the system included $5.9
million awarded in a previously announced contract with the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services
(HHS).
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
patented DPP technology platform, which uses a small drop of blood
from the fingertip, 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.
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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