NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization for SpectronRx's Hymon SARS-CoV-2 Test Kit.
According to the Indianapolis-based company, the test kit is designed to detect regions of the virus' nucleocapsid and envelope genes in upper respiratory specimens and bronchoalveolar lavage. It runs on Thermo Fisher Scientific's Applied Biosystems 7500 RT-PCR system.
Use of the test is limited to laboratories CLIA-certified to perform high-complexity tests, the FDA said.
The kit is manufactured by Suzhou, China-based HymonBio.