Co-Diagnostics Completes Submission of CE Marking Registration for COVID-19 Coronavirus Test

February 20, 2020 |

4 min read

Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ COVID-19 Test technical file has been submitted for registration with the European Community, and that it is expected to be available later this month as an in vitro diagnostic (“IVD”) for markets that accept a CE marking as valid regulatory approval.

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, announced today that its Logix Smart™ COVID-19 Test technical file has been submitted for registration with the European Community, and that it is expected to be available later this month as an in vitro diagnostic (“IVD”) for markets that accept a CE marking as valid regulatory approval.

Dwight Egan, CEO of Co-Diagnostics, commented, “We are pleased to announce this milestone, which comes after weeks of hard work by our team at Co-Diagnostics to develop a high-performance diagnostic to help prevent the spread of the new strain of coronavirus. Our patented CoPrimer™ molecules have unique properties that lead to a significant reduction in false positive test results over other polymerase chain reaction (PCR) technologies, but will also allow for enhanced multiplexing, or identifying multiple targets at once, as we iterate the test to include other strains of coronavirus and mutations of COVID-19.”

Co-Diagnostics’ Logix Smart COVID-19 Test uses the Company’s CoPrimer technology to detect the presence of ribonucleic acid (RNA) of the novel strain of coronavirus in a real-time RT-PCR kit that targets conserved regions in the virus genome. The virus was first identified in the Chinese city of Wuhan on January 7, before spreading to 25 more countries, infecting over 75,000 people, and causing nearly 2,130 deaths according to current data available on Johns Hopkins Center for Systems Science and Engineering. A representative for the US Centers for Disease Control and Prevention (CDC) said last week that in addition to the testing kits distributed by the CDC, it was critical for the private sector to develop diagnostics for COVID-19 that could be commercially scaled.

Mr. Egan continued, “The impact that this virus will have on the global economy and health of countless individuals continues to evolve. Co-Diagnostics is in the vanguard of commercializing diagnostics to help ameliorate the effects of COVID-19 by ensuring accurate diagnoses, and we are confident in our ability to scale to meet demand as necessary.”

The technical file dossier submitted to the Company’s authorized European representative includes a description of the test to support conformance to the CE marking standards, which will confirm that the test meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC). The registration process is expected to be complete later this month, at which point sales of the product may commence as a CE-marked IVD. Co-Diagnostics will manufacture its Logix Smart COVID-19 Test in the Company’s ISO 13485:2016 certified facility for the development and manufacture of IVD Medical Devices located in Utah, USA.

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 may include statements regarding the (i) use of funding proceeds, (ii) expansion of product distribution, (iii) acceleration of initiatives in certain verticals or markets, (iv) capital resources and runway needed to advance the Company’s products and markets, (v) increased sales in the near-term, (vi) flexibility in managing the Company’s balance sheet, (vii) anticipation of business expansion, and (viii) 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.