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Pro-Lab Diagnostics Nabs FDA Emergency Use Authorization for Molecular SARS-CoV-2 Test

NEW YORK ─ The US Food and Drug Administration on Thursday granted Emergency Use Authorization to Ontario, Canada-based Pro-Lab Diagnostics to conduct its Pro-AmpRT SARS-CoV-2 lab-developed test at the firm's Round Rock, Texas CLIA-certified facility.

Pro-AmpRT SARS-CoV-2 is a reverse-transcription, isothermal-amplification test that detects SARS-CoV-2 RNA in upper respiratory specimens ─ including nasal, nasopharyngeal, and oropharyngeal swabs ─ from people suspected of COVID-19 by their healthcare provider. The test's primer set consists of six primers and amplifies a 206 base-pair region of the ORF1ab gene of SARS-CoV-2.

The test is authorized to be used with OptiGene's Genie HT instrument.

The Pro-AmpRT SARS-CoV-2 test may be performed only at the firm's Round Rock, Texas facility, which meets requirements to conduct high-complexity tests, the FDA noted.