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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

Published: 08:09 24 Sep 2020 EDT

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 uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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