News | April 30, 2019

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

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.


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