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.
"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).
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