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Co-Diagnostics Completes FDA EUA Submission for Extraction-Free Saliva COVID-19 Test

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The Company's Logix Smart™ SARS-CoV-2 DS (Direct Saliva) test is designed to reduce sample processing time and cost by eliminating the extraction process

SALT LAKE CITY, Jan. 28, 2021 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that it has completed its submission to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) of its Logix Smart™ SARS-CoV-2 DS (Direct Saliva) test, a COVID-19 polymerase chain reaction (PCR) diagnostic designed to detect the presence of SARS-CoV-2 in human saliva samples without first requiring RNA extraction of the sample.

Co-Diagnostics Official Logo (PRNewsfoto/Co-Diagnostics)
Co-Diagnostics Official Logo (PRNewsfoto/Co-Diagnostics)

The Company's new Direct Saliva test is designed to reduce sample processing time and cost by eliminating extraction

PCR tests usually require a costly, time-consuming process intended to extract any genetic material present from the cells contained in the sample. These extracted samples are then analyzed for the presence of the target pathogen using PCR technology. Co-Diagnostics' Logix Smart SARS-CoV-2 DS test was developed following the Company's announcement that its patented CoPrimer™ technology was shown to be able to consistently detect SARS-CoV-2, the virus that causes COVID-19, directly from minimally processed saliva samples. The Company believes that eliminating the extraction process has the potential to increase throughput and lower costs of COVID-19 testing, all without compromising quality or accuracy.

"Our new extraction-free saliva test has been developed as part of our ongoing commitment to providing improved COVID-19 diagnostics for high-throughput laboratory settings, using technology with additional potential point-of-care applications," said Dwight Egan, Co-Diagnostics CEO. "We believe that this technology will help to meet the domestic and global need for high-quality COVID-19 tests that can be processed quickly and affordably, while retaining the advantages of PCR testing over other testing alternatives. It also represents a major step forward in a new generation of PCR tests that can be widely more accessible, and we look forward to offering additional cutting-edge molecular diagnostic tools in the continuing battle against COVID-19 and other diseases."

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 rely on any forward-looking statements. Any forward-looking statement made by the Company in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. 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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SOURCE Co-Diagnostics