Co-Diagnostics, Inc. Technology to be Used in FDA-Authorized Self-Collected COVID-19 Saliva Test

Rhea-AI Summary

Co-Diagnostics, Inc. (Nasdaq: CODX) announced that its partner, Clinical Reference Laboratory (CRL), received FDA Emergency Use Authorization for the CRL Rapid Response™ COVID-19 saliva test. This self-administered test uses Co-Diagnostics' patented CoPrimer™ technology, enhancing sensitivity and specificity.

CEO Dwight Egan expressed confidence in the Co-Diagnostics platform, highlighting its potential to facilitate a safe return to normalcy. The Logix Smart COVID-19 test by Co-Diagnostics is also available for clinical laboratories in the US and other countries.

Positive

• FDA Emergency Use Authorization for CRL Rapid Response™ COVID-19 saliva test.
• Self-administered test enhances accessibility and convenience.

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• None.

SALT LAKE CITY, Aug. 3, 2020 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its partner, Clinical Reference Laboratory (CRL) has received FDA Emergency Use Authorization for CRL Rapid Response™, a saliva-based COVID-19 test that can be self-administered at home, work or any other setting and then tested using Co-Diagnostics' patented CoPrimer™ technology.

According to CRL's announcement, Co-Diagnostics technology drives the higher sensitivity and specificity of the self-administered CRL Rapid Response test. CRL is one of the largest privately held clinical testing laboratories in the U.S., with dedicated facilities in North America and Europe.

"We believe that CRL's selection of the Co-Diagnostics platform, and their successful emergency use authorization from the FDA, speaks volumes about the quality, sensitivity, and specificity of our CoPrimer primer and probe technology," remarked Dwight Egan, CEO of Co-Diagnostics. "Co-Diagnostics is pleased to be a part of a testing initiative with so much potential to help people return to work, school, and normal life as quickly and safely as possible.

The CE-marked and FDA EUA Co-Diagnostics Logix Smart COVID-19 test is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA), and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19, in the US and many other countries.

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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SOURCE Co-Diagnostics

FAQ

What is the significance of the FDA Emergency Use Authorization for CODX?

The FDA Emergency Use Authorization for the CRL Rapid Response™ test signifies regulatory approval for a self-administered COVID-19 saliva test utilizing Co-Diagnostics' technology, enhancing the company's market presence.

How does the Co-Diagnostics technology improve COVID-19 testing?

Co-Diagnostics' technology improves COVID-19 testing through its patented CoPrimer™ technology, which increases the sensitivity and specificity of the CRL Rapid Response test.

When was the FDA Emergency Use Authorization granted for the CODX saliva test?

The FDA Emergency Use Authorization for the CRL Rapid Response™ test was announced on August 3, 2020.

What type of test has Co-Diagnostics developed for COVID-19?

Co-Diagnostics has developed a saliva-based COVID-19 test that is self-administered, allowing individuals to collect samples at home or in other settings.