NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization to Gnomegen's COVID-19 RT-Digital PCR Detection kit for diagnosing SARS-CoV-2 infection.
According to the FDA, the in vitro diagnostic is designed for the qualitative detection of the nucleocapsid gene of the SARSCoV-2 virus in nasal, nasopharyngeal, and oropharyngeal swab specimens collected by healthcare providers. It runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 3D Digital PCR system.
The test is only authorized for use by CLIA-certified laboratories, which are required to report positive cases to health authorities, the FDA noted.
San Diego-based Gnomegen markets a digital PCR instrument and related cancer assays including ones for the detection of HER2 amplification and EGFR mutations.