Enzo Biochem receives expanded EUA from FDA

Jan. 5, 2021

Enzo Biochem announced that it has received an expanded emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of pooled samples with the company’s RT-PCR SARS-CoV-2 test, according to a press release.

The AMPIPROBE SARS-Cov-2 Test System is designed for three different platforms including Enzo’s proprietary GENFLEX automated high-throughput platform, the company said.

The EUA authorizes pooling of samples from up to five individual upper respiratory swab specimens collected in separate vials containing transport media. Samples can include nasal, mid-turbinate, nasopharyngeal, or oropharyngeal swabs.

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