NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization to Ipsum Diagnostics for the company's RT-PCR-based SARS-CoV-2 test.
According to the FDA, the test, called COV-19 IDx, is designed to detect a region in the SARS-CoV-2 nucleocapsid gene, as well as human RNase P as a control, in nasopharyngeal and oropharyngeal swab specimens. Nucleic acid extraction is performed using Thermo Fisher Scientific's KingFisher Flex nucleic acid extraction system and the Omega Bio-Tek Mag-Bind Viral DNA/RNA 96 kit, and the test runs on Thermo Fisher's Applied Biosystems QuantStudio 12 K Flex instrument.
Emergency use of the test is limited to Ipsum and other authorized laboratories, the FDA noted.
Atlanta-based Ipsum is offering COV-19 IDx supplies and kits via a physician portal on its website.