Research & Development
SML Genetree wins FDA's EUA for Ezplex SARS-CoV-2 G PCR Kit with specimen pooling capability
15 January 2021 -

Molecular technologies company SML Genetree reported on Thursday the receipt of the Emergency Use Authorization (EUA) from the US FDA for the use of its Ezplex SARS-CoV-2 G Kit for the qualitative detection of RNA from SARS-CoV-2 specimens and swabs.

The company said that the specimens are to be collected by a healthcare provider using individual vials containing transport media.

In addition, the company's Ezplex SARS-CoV-2 G Kit test is authorized for use in laboratories in the US certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.

According to the company, Ezplex SARS-CoV-2 G Kit is a molecular diagnostic test for the qualitative detection of RNA from SARS-CoV-2 from nasopharyngeal swabs, oropharyngeal swabs and sputum specimens as well as for use in pooled patient specimens containing up to five upper respiratory swab specimens. Sample pooling allows for more people to be tested quickly using fewer testing resources.

Concurrently, the company's Ezplex SARS-CoV-2 G Kit is designed to provide sensitive and accurate results by detecting two different regions of the SARS-CoV-2 virus: the RdRP and N genes. Results are available in approximately two and half hours post RNA extraction.

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