Co-Diagnostics, Inc. Files Provisional Patent for Simplified Targeted NGS Library Preparation

Method includes proprietary, single-step closed-tube NGS library
prep in 3 hours or less

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, today announced today the filing of a
provisional patent with the USPTO for its single-step next generation
sequencing (NGS) library preparation methods and composition, claiming
an exclusive privilege and/or right to practice the invention, which
also embodies the use of the Company’s patented CoPrimer™ technology in
the process. The technology has numerous applications in liquid biopsy
and oncology, agrigenomics, and infectious diseases.

NGS is a powerful DNA sequencing technology enabling the
mapping or identifying of a large number of DNA fragments
simultaneously. The first stage of the NGS process is the library
preparation, which involves generating a collection of DNA fragments for
sequencing. Co-Diagnostics’ proprietary approach to library preparation
covered under the patent filing is a single-step, closed-tube polymerase
chain reaction (PCR) process taking up to 3 hours with less than 30
minutes of hands-on labor, compatible with existing platforms such as
Ion Torrent and Illumina. In comparison, traditional methods to prepare
an NGS targeted library generally take several steps, 7-8 hours, and 2-4
hours of labor.

Company CEO Mr. Dwight Egan remarked, “The growth of sequencing-based
research and business opportunities are highly dependent upon the
technological strength of a given sequencing platform, and researchers
at Co-Diagnostics recognized the need for a method of library
preparation to reduce preparation and user hands-on time. This dramatic
reduction in preparation and laboratory personnel time and resources
meets the very distinct need for increased throughput and reduced costs
in NGS research. The innovation of this proprietary method is a direct
result of our mandate to use lower-cost molecular diagnostics solutions
to improve the quality of life of those to whom the advantages of
cutting-edge technology may have previously been out of reach.

“Furthermore, the application of PCR in this manner falls outside of the
definition of an in-vitro diagnostic according to the Food and
Drug Administration, meaning it is not subject to the same strict
regulatory requirements as those devices,” continued Mr. Egan. “We
anticipate that fewer regulatory concerns will provide greater near-term
domestic revenue opportunities associated with offering more affordable
NGS solutions to the U.S. market.”

Sequencing is used to study a broad spectrum of genetic mutations that
might be associated with diseases, or to identify which sequences of a
gene that will respond better to certain therapeutics, including cancer
genome and individual cancer sequencing to enable more precise diagnoses
and personalized treatment. It can be applied to sequencing an entire
genome or targeting and sequencing selected regions of interest.
Targeted amplicon sequencing allows researchers to sequence a subset of
genes or specific genomic regions of interest.

For more information on using this product in your laboratory or
research center, contact Joseph Featherstone, Co-Diagnostics Head of
Business Development, at: j.featherstone[at]codiagnostics.com

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
Head of Investor Relations
+1 801-438-1036
investors@codiagnostics.com