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.