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Co-Diagnostics, Inc. Logix Smart Kit to be Used with Newly Authorized Saline Oral Rinse Collection

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Co-Diagnostics (Nasdaq: CODX) announced that Access Genetics' OralDNA Labs received an amended Emergency Use Authorization (EUA) for a COVID-19 RT-PCR test, utilizing Co-Diagnostics' Logix Smart™ COVID-19 kit. This test allows for a saline oral rinse collection, which could enhance testing comfort and accessibility. CEO Dwight Egan noted that this represents the first FDA authorization for a test using oral rinse technology, underscoring the adaptability of the company's CoPrimer™ platform. The announcement highlights the potential for improved community testing.

Positive
  • Access Genetics' OralDNA Labs received amended EUA for COVID-19 RT-PCR test, enhancing Co-Diagnostics' product adoption.
  • Test utilizes a saline oral rinse collection, improving patient comfort and accessibility.
  • FDA authorization marks a milestone for Co-Diagnostics' technology in diagnostics.
Negative
  • None.

SALT LAKE CITY, Oct. 2, 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 Access Genetics, LLC dba OralDNA® Labs, a CLIA-certified customer who uses the Company's Logix Smart™ COVID-19 kit in their FDA authorized OraRisk® COVID-19 RT-PCR test, recently received an amended Emergency Use Authorization (EUA) allowing testing from a saline oral rinse collection.

OralDNA's original release can be seen here.

Dwight Egan, CEO of Co-Diagnostics, remarked: "We are pleased that Co-Diagnostics technology is being used in the first FDA EUA for a test using a simple saline 30 second swish and gargle collection. Because it eliminates the need for a nasal swab, oral rinse technology has the potential to dramatically improve comfort and accessibility of testing in our communities and we believe this authorization by the FDA provides additional confirmation of the quality, versatility, and adaptability of our CoPrimer™ platform."

About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a 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.

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/co-diagnostics-inc-logix-smart-kit-to-be-used-with-newly-authorized-saline-oral-rinse-collection-301144627.html

SOURCE Co-Diagnostics

FAQ

What is the significance of CODX's technology in the newly authorized COVID-19 test?

Co-Diagnostics' technology is used in the first FDA EUA for a COVID-19 test utilizing a saline oral rinse, enhancing accessibility and comfort for patients.

When did Co-Diagnostics announce the amended EUA for its COVID-19 test?

Co-Diagnostics announced the amended EUA on October 2, 2020.

What benefits does the saliva-based COVID-19 test provide?

The saliva-based test provides improved comfort and accessibility compared to traditional nasal swab tests.

How does the new testing method potentially impact community testing?

By allowing a simple saline oral rinse, the new method may increase participation in COVID-19 testing in communities.

What is the role of the Logix Smart™ COVID-19 kit in the new EUA?

The Logix Smart™ COVID-19 kit is utilized in the authorized test by OralDNA Labs for detecting COVID-19.

Co-Diagnostics, Inc.

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