NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for Trax Management Services' PCR-based SARS-CoV-2 test.
According to the FDA, the PhoenixDx 2019-CoV test is designed to detect SARS-CoV-2 E and RDRP genes in nasal, nasopharyngeal, and oropharyngeal swabs, as well as bronchoalveolar lavage specimens. It runs on any authorized RT-PCR instrument and can be performed by labs CLIA-certified to perform high-complexity tests.
The test was developed by Thalgau, Austria-based Procomcure Biotech. Lewis Center, Ohio-based Trax sources pharmaceutical and medical products.