Skip to main content

FDA Grants Emergency Use Authorization for Bioeksen's Molecular Coronavirus Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Bioeksen R&D Technologies.

The Bio-Speedy Direct RT-qPCR SARS-CoV-2 is designed for the detection of the virus' ORF1ab gene in nasopharyngeal, oropharyngeal, combined nasopharyngeal/oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasal or nasopharyngeal aspirates, nasal washes, and bronchoalveolar lavage specimens.

It can run on Roche's LightCycler 96 instrument, Bio-Rad Laboratories' CFX96 Touch RT-PCR Detection System, and Qiagen's Rotor-Gene Q 5plex HRM Platform, according to Istanbul-based Bioeksen.

The test may be used by any lab CLIA-certified to perform high-complexity tests.