Enzo Biochem Inc has received FDA Emergency Use Authorization (EUA) for its Ampiprobe SARS-Cov-2 Test System for the detection of SARS-CoV-2. The system includes three components: sample collection, Ampixtract SARS-CoV-2 Extraction Kit for sample processing, and the Ampiprobe SARS-CoV-2 Assay Kit for detection and analysis.
The EUA allows other laboratories to use Enzo’s products with three diverse platforms without requiring further validation:
- Enzo’s automated Genflex 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;
- Qiagen’s QIAsymphony SP platform, for detection and analysis in conjunction with nucleic acid extraction;
- and Enzo’s manual workflow.
In its letter of authorization dated July 7, 2020, the FDA stated: “The above described product, when accompanied by the instructions for use and the two fact sheets (collectively referenced as “authorized labeling”), is authorized to be distributed and used by authorized laboratories under this EUA.”
“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, PhD, 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.”
A new white paper titled “Enzo’s Emergency Use Authorized Ampiprobe SARS-CoV-2 Test System” is currently available on its website, along with two previously published white papers detailing Enzo’s COVID-19 Product and Platform.