Co-Diagnostics, Inc. Receives CE Mark for Zika/Dengue/Chikungunya Multiplex Test
March 07 2019 - 6:30AM
Business Wire
Logix Smart™ ZDC Test now available for
export from the United States as a CE-marked IVD
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 Test has obtained CE mark regulatory clearance to
be sold as an in vitro diagnostic (“IVD”) for the diagnosis of
Zika, dengue, and chikungunya in accepting markets, and is now
available for purchase from the Company’s Utah-based ISO-13485
facility.
The Declaration of Conformity for the Logix Smart ZDC test
confirms that it meets the Essential Requirements of the European
Community’s In-Vitro Diagnostic Medical Device Directive (IVDD
98/79/EC), allowing export and sales of the product to commence
immediately to markets that accept a CE mark as valid IVD
regulatory approval, pending any local product registration
requirements. These markets include several countries across the
Caribbean basin and Latin America in which the Company already has
distribution agreements in place. Co-Diagnostics expects regulatory
approval for such a high-demand test to facilitate the creation of
additional sales and distribution opportunities in those areas.
Dwight Egan, Chief Executive Officer of Co-Diagnostics,
commented, “Receiving the CE mark for our CoPrimer™-based multiplex
ZDC assay is the capstone of the design, development, validation,
and regulatory approval process, which was completed from start to
finish in under 6 months. This highly-specific diagnostic for three
harmful diseases at once is possible due to our patented CoPrimer
design platform enabling a massive reduction in false positives,
which is especially important—but notoriously more difficult—in
multiplexed assays of related pathogens. The exceptional
performance of the Logix Smart ZDC test and our efficient
development process are both further validations of our technology,
and of the quality of our dedicated personnel.
Over 50% of the world’s population live in zones at risk for
infection of one or more of Zika, dengue, or chikungunya. With
increased reported infections rates on the rise for all three
diseases, we believe that this test will have an important and
valuable role to play in delivering an affordable diagnostic
solution for early, accurate detection to our cost-conscious target
market.”
Co-Diagnostics’ Logix Smart ZDC Test functions via a single-step
reverse transcriptase real-time polymerase chain reaction to
identify and differentiate between the viral RNA of Zika, dengue
(all 4 serotypes), and chikungunya. 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. More information related to performance, distribution,
or purchasing can be found at
http://codiagnostics.com/products/diagnostic-solutions/logix-smart-zdc/
or via the Company contact at the bottom of this release.
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/20190307005215/en/
Seth EganHead of International Sales+1 801-438-1036
#2s.egan@codiagnostics.com
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