Chembio Diagnostics Receives CE Mark for Point-of-Care Diagnostic Test Developed in Collaboration with AstraZeneca
January 07 2019 - 6:00AM
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care
diagnostics company focused on infectious diseases, today announced
that it has received a CE mark for its diagnostic test developed in
collaboration with AstraZeneca, a global biopharmaceutical company.
Chembio and AstraZeneca have collaborated to
develop a quantitative diagnostic test to detect an undisclosed
biomarker, using Chembio’s patented DPP® platform. The CE marked
DPP® System, which includes the new DPP® test and DPP® Micro
Reader, provides quantitative results in ten minutes from a small
drop of fingertip or venous blood.
“We are pleased to receive the CE mark within 12
months of announcing the collaboration with AstraZeneca. This
achievement highlights both our technical expertise and the speed
at which we can bring tests to market,” said John Sperzel,
Chembio’s Chief Executive Officer. “We look forward to working
closely with AstraZeneca in pursuit of additional regulatory
approvals.”
In December 2017, Chembio announced an 18-month
agreement with AstraZeneca, under which Chembio will receive up to
$2.9 million in funding from AstraZeneca, subject to satisfying
certain milestones, to develop a quantitative reader-based
point-of-care test utilizing Chembio’s patented DPP® platform. The
DPP® platform is the same technology used for Chembio’s DPP® HIV
1/2 Assay, which is FDA-approved, CLIA Waived, CE marked, and WHO
pre-qualified.
About Chembio
DiagnosticsChembio Diagnostics, Inc. is a leading
point-of-care diagnostics company focused on detecting and
diagnosing infectious diseases. 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, a number of which are under
active development with collaboration partners. 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.
Headquartered in Medford, NY, Chembio is
registered with the U.S. Food and Drug Administration (FDA) as well
as the U.S. Department of Agriculture (USDA), and is certified for
the global market under the International Standards Organization
(ISO) directive 13485. Learn more at www.chembio.com.
Media contact:
Lynn
Pieper LewisGilmartin Group(415) 937-5402investor@chembio.com |
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