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FDA Grants Emergency Use Authorization for GK Pharmaceuticals Coronavirus Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by GK Pharmaceuticals Contract Manufacturing Operations (GK CMO).

The GK Accu-Right SARS-CoV-2 RT-PCR Kit is designed to detect two regions within the virus' nucleocapsid gene in upper respiratory specimens collected by a healthcare provider, such as nasopharyngeal, oropharyngeal, mid-turbinate, or nasal swabs.

According to the Puerto Rico-based company, the test uses Qiagen's QIAamp Viral RNA Mini Kit for RNA extraction and runs on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx RT-PCR instrument.

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