Enzo Biochem Secures FDA Emergency Use Authorization for Proprietary Coronavirus Detection Test System

Enzo Biochem (New York, NY, USA) has received Emergency Use Authorization (EUA) from the FDA for its proprietary product for the detection of Coronavirus SARS-CoV-2 enabling other laboratories to use the company’s products with three diverse platforms without requiring further validation.

The AMPIPROBE SARS-CoV-2 Test System is a complete workflow solution based on the real-time reverse transcription polymerase chain reaction (qRT-PCR) technology and designed for the qualitative detection of nucleic acids from SARS-CoV-2 virus. It features improved scale, high sensitivity, particularly relevant positive controls comprising in vitro transcribed viral RNA, and RNaseP as an internal control to confirm the quality of the specimen collection and the nucleic acid extraction process. The AMPIPROBE SARS-Cov-2 Test System includes AMPICOLLECT Saline, Normal for sample collection of upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate specimens), the AMPIXTRACT SARS-CoV-2 Extraction Kit, AMPIPROBE SARS-CoV-2 Assay Kit and AMPIPROBE SARS-CoV-2 Controls kit, and the high-throughput GENFLEX platform.

Pursuant to receiving the Emergency Use Authorization, Enzo’s diagnostics division is offering the AMPIPROBE SARS-Cov-2 Test System for use with three platforms. The first platform is Enzo’s proprietary automated GENFLEXTM platform, which is a high-throughput, sample-to-result open molecular diagnostics system that delivers high capacity, efficiency, and flexibility at a lower price point than competing systems. The second platform is for the use of Enzo’s proprietary test for detection and analysis in conjunction with nucleic acid extraction on the QIAsymphony SP platform. Lastly, the FDA has authorized the use of Enzo’s proprietary test on a manual workflow.

“This is an important milestone for Enzo as the FDA’s EUA on three disparate systems demonstrates the flexibility and adaptability of our highly reliable and sensitive PCR-based molecular test for SARS-Cov-2,” said Elazar Rabbani, Ph.D., Enzo CEO. “The EUA builds upon our comprehensive COVID-19 program and the diagnostic testing efforts we first announced in April, which have already garnered significant interest from government entities, nursing homes, and universities as they plan testing programs for their constituents.”

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