Co-Diagnostics, Inc. Logix Smart™ COVID-19 Test Authorized for Use in Australia
Co-Diagnostics, Inc. (Nasdaq: CODX) has announced that the Logix Smart™ COVID-19 test has received authorization for use in Australia. This approval allows the Company to expand its market presence, joining other regions like the United States and India. The test, which is CE-marked and has FDA EUA, is now available through the Company’s distributor in Australia. This comes amid rising COVID-19 cases in Melbourne, necessitating enhanced testing capabilities.
- Logix Smart COVID-19 test authorized for use in Australia, expanding market reach.
- The test is now available to clinical laboratories certified under CLIA in multiple countries.
- Rising COVID-19 cases in Melbourne may lead to increased competition and scrutiny.
SALT LAKE CITY, Aug. 7, 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 Australia has been added to the list of countries that have authorized the Logix Smart™ COVID-19 for use in detecting SARS-CoV-2, the virus that causes COVID-19.
Australia joins the United States, India, Mexico, the European Community and others as a region where the Company's test can be sold and used as a coronavirus in vitro diagnostic (IVD). The Australian Government Register of Therapeutic Goods Certificate was recently issued to the Company's distributor in Australia, approving the distributor to supply the Class 3 IVD to the Australian market.
Dwight Egan, CEO of Co-Diagnostics, commented, "Co-Diagnostics recognizes the importance of accurate, high-throughput testing in combating surges of coronavirus infections, and we are gratified that our test is being used to help people in so many countries to safely navigate this ongoing pandemic, now also including Australia."
The news follows recent reports of a soaring coronavirus outbreak in Melbourne, prompting the state of Victoria to declare a "state of disaster" and to strengthen lockdown measures.
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.
Company Contact: | Media Contact: |
Andrew Benson | Jennifer Webb |
Head of Investor Relations | Coltrin & Associates, Inc |
+1 801-438-1036 | +1.267.912.1173 |
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SOURCE Co-Diagnostics
FAQ
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