Co-Diagnostics Completes Submission of CE Mark Registration for Zika/Dengue/Chikungunya Multiplex Test
February 26, 2019
Company’s multiplexed Logix Smart™ ZDC Test to be available for
purchase with CE mark in March 2019
SALT LAKE CITY–(BUSINESS WIRE)–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.
Contacts
Andrew Benson
Co-Diagnostics Investor Relations
801-438-1036
investors@codiagnostics.com