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FDA Grants Emergency Use Authorization for Inform Diagnostics Coronavirus Test

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

The company's SARS-CoV-2 RT-PCR Assay, which is based on the US Centers for Disease Control and Prevention's CDC 2019-nCoV Real-Time RT-PCR panel, is designed to detect two regions of the virus' nucleocapsid gene in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates and bronchoalveolar lavage specimens.

Nucleic acid purification is performed using Millipore Sigma's ViralXpress DNA/RNA Extraction Reagent and the test runs on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx Real-Time PCR instrument.

The assay may only be performed at Phoenix, Arizona-based Inform, according to the FDA. The company provides anatomic pathology services, including dermatopathology, gastrointestinal pathology, hematopathology, breast pathology, and urologic pathology.