Co-Diagnostics, Inc. Receives CE Mark for Zika/Dengue/Chikungunya Multiplex Test

Logix Smart™ ZDC Test now available for export from the United
States as a CE-marked IVD

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
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.

Contacts

Seth Egan
Head of International Sales
+1 801-438-1036 #2
s.egan@codiagnostics.com

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