Clinical Reference Laboratory’s FDA-authorized saliva-based PCR test uses technology developed by Co-Diagnostics to detect SARS-CoV-2
SALT LAKE CITY, Feb. 25, 2021 /PRNewswire/ — Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that laboratory partner Clinical Reference Laboratory’s (CRL) FDA-authorized Rapid Response COVID-19 Saliva Test, which uses Co-Diagnostics CoPrimer™ technology, is now available through Walgreens Find Care®, allowing consumers a convenient, non-invasive option for PCR-based COVID-19 testing from their own homes.
CRL’s release states:
The HealthConfirm®-branded COVID-19 Saliva Test leverages the same FDA-authorized Clinical Reference Laboratory COVID-19 PCR testing technology used by numerous organizations across various industries including major universities and school districts, top financial institutions, film and TV productions as well as casinos and more.
Co-Diagnostics is proud that our technology will be available on an even more widespread basis.
Saliva samples sent to CRL are tested with its saliva-based COVID-19 RT-PCR test, which functions via patented CoPrimer probes and primers developed by Co-Diagnostics to detect SARS-CoV-2 (the virus that causes COVID-19) viral RNA.
Dwight Egan, Co-Diagnostics CEO, stated, “Co-Diagnostics is proud that our technology will be available on an even more widespread basis following this announcement by our trusted partner CRL, one of the largest privately-held clinical testing laboratories in the U.S. We strongly believe in the importance of providing gold-standard PCR diagnostic solutions to as many people as possible, and at-home collection devices are a critical component to achieving this level of accessibility.”
CRL’s Rapid Response COVID-19 Saliva Test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by Clinical Reference Laboratory, Inc., located in Lenexa, Kan.; has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Similar to other tests with FDA EUAs currently in the market, this test has not been formally FDA cleared or approved.
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.
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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