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Biocollections Worldwide, Gnomegen Get FDA Emergency Use Authorizations for Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by Biocollections Worldwide and Gnomegen.

Biocollections' SARS-CoV-2 assay is an RT-PCR test designed to detect the nucleocapsid (N) gene of the virus in upper respiratory specimens, such as nasal swabs and oropharyngeal swabs, and bronchoalveolar lavage. It runs on Abbott's automated m2000 system and may only be performed at the Miami, Florida-based company's CLIA laboratory.

The Gnomegen COVID-19-RT-qPCR Detection Kit is designed to detect the SARS-CoV-2 N gene in nasopharyngeal and oropharyngeal swab specimens, and may be used by any lab CLIA certified to perform high-complexity tests. It uses Qiagen's QIAmp DSP Viral RNA Mini Kit for RNA purification and sample concentration and runs on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with SDS 1.4 software.

Last month, San Diego-based Gnomegen received an EUA for its COVID-19 RT-Digital PCR Detection kit.

Rehovot, Israel-based Todos Medical said on Monday that it has acquired the exclusive distribution rights for Gnomegen's digital PCR and qPCR SARS-CoV-2 tests in North America, Europe, Southeast Asia, and Latin America. It added that has completed validation testing for the qPCR reagents and is preparing to launch the test in the US through its partner CLIA lab.