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Sinochips Bioscience Gets FDA Emergency Use Authorization for Coronavirus Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Sinochips Bioscience.

The COVID-19 Nucleic Acid RT-PCR Test Kit is designed to detect the ORF1ab and nucleocapsid genes of the virus in upper respiratory specimens, according to the Zhuhai, China-based company. It uses Qiagen's QIAamp Viral RNA Mini Kit for manual nucleic acid extraction or Thermo Fisher Scientific's KingFisher Flex Magnetic Particle Processor for automated extraction and runs on Thermo Fisher's Applied Biosystems 7500 Fast Dx or Applied Biosystems 7500 RT-PCR instruments.

The test may be used by any lab CLIA-certified to perform high-complexity testing, the FDA said.