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Co-Diagnostics says its Logix Smart “ABC” Test will be ready for US CLIA lab customers in first week of October

The company’s Logix Smart “ABC” test kit will be used to test for Influenza A, Influenza B, and coronavirus

Co-Diagnostics - Co-Diagnostics Inc says its Logix Smart “ABC” Test will be ready for US CLIA lab customers in first week of October
Co-Diagnostics CEO Dwight Egan said the company was working to contribute to the safety of people at a time when the "need for accurate detection of COVID-19 as well as the differentiation between strains of the flu has never been greater"

Co-Diagnostics Inc (NASDAQ:CODX) (FRA:C97), a molecular diagnostics company, announced on Thursday that its Logix Smart ABC Test for Influenza A, Influenza B, and coronavirus (COVID-19) is anticipated to be ready for launch to US CLIA lab customers in the first week of October.

CLIA is regulated by the Centers for Medicare & Medicaid Services, with a primary goal to ensure quality laboratory testing.

"Co-Diagnostics is committed to participating in the fight against COVID-19 through the development and manufacture of vital diagnostic testing solutions, with none perhaps as important as this upcoming ABC multiplex test," Co-Diagnostics CEO Dwight Egan said in a statement.

READ: Co-Diagnostics' detection of infectious disease has led it to join the coronavirus fight with flagship test

"Our patented CoPrimer technology platform is ideally suited for multiplex reactions by substantially reducing 'primer-dimers,' a phenomenon in PCR molecular tests that results in false-positive results. At a time when the need for accurate detection of COVID-19 as well as the differentiation between strains of the flu has never been greater, we are pleased to be able to contribute to the safety and well-being of communities across the country and around the world."

The test will initially be made available to CLIA labs, which will be using it in their own laboratory-developed tests, or LDTs, while the company proceeds with the US Food and Drug Administration Emergency Use Authorization submission and CE marking registration.

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 the COVID-19 disease, in the US and many other countries.

The Utah-based company’s technology is utilized for tests that are designed using the detection and or analysis of nucleic acid molecules (DNA or RNA).

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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NASDAQ:CODX
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