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FDA Grants EUAs for Enzo Life Sciences, Access Bio, Gene By Gene Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Enzo Life Sciences, Access Bio, and Gene By Gene.

Enzo's Ampiprobe SARS-CoV-2 Test System is a multiplexed RT-PCR assay designed to target two regions in the nucleocapsid (N) gene of the virus in upper respiratory specimens. It uses magnetic-particle technology for nucleic acid isolation and purification, and it runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 instrument, according to the Farmingdale, New York-based company.

Access Bio's CareStart COVID-19 MDx RT-PCR test is designed to detect the SARS-CoV-2 N and RdRP genes in upper respiratory and bronchoalveolar lavage specimens. Nucleic acid extraction is performed using Qiagen's QIAamp Viral RNA Mini Kit and the test runs on Thermo Fisher's Applied Biosystems 7500 or 7500 Fast RT-PCR instruments, according to the Somerset, New Jersey-based company.

Both the Enzo and Access Bio tests may be used by any lab CLIA-certified to perform high-complexity testing.

The Gene By Gene SARS-CoV-2 Detection Test is designed to detect the virus N gene in nasal swab and nasopharyngeal swab specimens. Nucleic acid is extracted on the Qiagen QIAcube HT instrument using the miRNeasy Serum/Plasma Advanced kit and the test runs on Bio-Rad's CFX384 Touch Real-Time PCR Detection System.

According to the FDA, the test may only be performed by Houston, Texas-based Gene By Gene.