Co-Diagnostics Completes Submission of CE Mark Registration for Zika/Dengue/Chikungunya Multiplex Test
February 26 2019 - 06:30AM
Business Wire
Company’s multiplexed Logix Smart™ ZDC Test
to be available for purchase with CE mark in March 2019
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, patented platform for the
development of molecular diagnostic tests, announced today that its
Logix Smart™ ZDC (multiplex Zika-dengue-chikungunya) Test technical
file has been submitted for registration with the European
Community, and that the in vitro diagnostic (“IVD”) is expected to
be available for purchase in March 2019 in markets that accept a CE
mark as valid regulatory approval.
Dwight Egan, Chief Executive Officer of Co-Diagnostics,
remarked, “We are pleased to announce the launch of the Company’s
first multi-disease diagnostic, built using our patented CoPrimer™
design platform. The unique properties of CoPrimer molecules not
only lead to a massive reduction in “primer-dimers,” the
often-occurring phenomenon that creates false positives in these
types of diagnostics, but they are also ideally suited for
multiplexing, or identifying multiple targets at once. Our
multiplex test for Zika, dengue, and chikungunya was developed in
direct response to market demand for an affordable, highly-specific
diagnostic tool for all three diseases.”
Co-Diagnostics’ Logix Smart ZDC Test functions via real-time
reverse transcriptase polymerase chain reaction (RT-PCR) to
differentiate between the RNA of Zika, dengue (all 4 serotypes),
and chikungunya viruses and to detect and amplify regions of the
viruses’ genomes. The three viruses are spread by the same Aedes
mosquitos and have similar symptoms, including sever fever and
joint pain, which has historically led to false diagnoses. However,
therapeutics differ for the three diseases, and physicians require
accurate diagnostic tools that can detect and distinguish between
the viruses in order to determine the most appropriate
treatment.
Mr. Egan continued, “Enhanced specificity—or discriminating
between similar genetic sequences to avoid false positive
diagnoses—is one of the most valuable characteristics of the
CoPrimer technology, especially in multiplexed assays. Our ZDC
multiplex test provides patients and health care providers a
low-cost solution to test for all three viruses at once, with the
confidence that the test results will aid in determining the most
suitable treatment for each patient. Early and accurate detection
of severe dengue, for example, can lower the mortality rate to
below 1% from as high as 50% when left untreated or treated
improperly. With over 50% of the world’s population living in zones
at risk for infection, and increased reported infections rates on
the rise for all three diseases, we anticipate a robust market for
this high-demand product.”
The technical file dossier submitted to the Company’s authorized
European representative includes a description of the test to
support conformance to the CE marking standards, which will confirm
that the test meets the Essential Requirements of the European
Community’s In-Vitro Diagnostic Medical Device Directive (IVDD
98/79/EC). The registration process is expected to be complete by
early March, at which point sales of the product may commence as an
IVD with the CE marking included. Co-Diagnostics will manufacture
its Logix Smart ZDC Test in the Company’s ISO 13485:2016 facility
for development and manufacture of IVD Medical Devices located in
Utah, USA.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets a new,
state-of-the-art diagnostics technology. The Company’s technology
is utilized for tests that are designed using the detection and/or
analysis of nucleic acid molecules (DNA or RNA). The Company also
uses its proprietary technology to design specific tests to locate
genetic markers for use in industries other than infectious disease
and license the use of those tests to specific customers.
Forward-Looking Statements:
This press release contains forward-looking statements.
Forward-looking statements can be identified by words such as
"believes," "expects," "estimates," "intends," "may," "plans,"
"will" and similar expressions, or the negative of these words.
Such forward-looking statements are based on facts and conditions
as they exist at the time such statements are made and predictions
as to future facts and conditions. Forward-looking
statements in this release include statements regarding the (i) use
of funding proceeds, (ii) expansion of product distribution, (iii)
acceleration of initiatives in liquid biopsy and SNP detection,
(iv) use of the Company’s liquid biopsy tests by laboratories, (v)
capital resources and runway needed to advance the Company’s
products and markets, (vi) increased sales in the near-term, (vii)
flexibility in managing the Company’s balance sheet, (viii)
anticipation of business expansion, and (ix) benefits in research
and worldwide accessibility of the CoPrimer technology and its
cost-saving and scientific advantages. Forward-looking statements
are subject to inherent uncertainties, risks and changes in
circumstances. Actual results may differ materially from
those contemplated or anticipated by such forward-looking
statements. Readers of this press release are cautioned not to
place undue reliance on any forward-looking statements. The Company
does not undertake any obligation to update any forward-looking
statement relating to matters discussed in this press release,
except as may be required by applicable securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20190226005458/en/
Andrew BensonCo-Diagnostics Investor
Relations801-438-1036investors@codiagnostics.com
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