Enzo Biochem Launches Proprietary COVID-19 Diagnostic Test

(New York, NY, USA) has launched its Comprehensive COVID-19 Program incorporating its molecular diagnostic virus screening products, detection for immunity through IgG/IgM serological ELISA products, detection of inflammation on Enzo’s ELISA platform, and a promising proprietary drug candidate (SK1-I). Enzo’s Diagnostics division is currently offering next-generation COVID-19 test kits under the FDA’s Emergency Use Authorization (EUA) authority.

The tests, which use Enzo’s proprietary GENFLEX open diagnostic platform, include a collection system, sample processing and molecular analytic products that address and circumvent the supply shortfalls throughout the diagnostic market. GENFLEX is Enzo’s high-throughput, sample-to-result platform that delivers high capacity, efficiency, and flexibility at a lower price point than existing systems.

Enzo’s new COVID-19 test features improved scale, sensitivity, and more relevant positive control materials. The company’s control, RNAseP, confirms the presence of human mucosa cells in the specimen, verifying accurate collections. The RNA positive control closely resembles in vivo conditions.

In addition, as part of Enzo’s Comprehensive COVID-19 Program, the company is developing gG/IgM antibody test for immunity detection, cytokine storm immunoassay for inflammation monitoring, and studies on potential use of its drug candidate SK1-I for the prevention and/or treatment of cytokine release syndrome and respiratory failure in COVID-19 patients.

“Enzo is uniquely positioned to address the COVID-19 pandemic from multiple angles. We have an open molecular diagnostic system with complete capabilities from sample collection to processing, detection, and analytics. Our open system allows for adoptability with regards to reagents, supplies, and instruments. This system can be used for the current COVID-19 crisis, and furthermore it can be repurposed for any current or future infectious agent diagnosis. Our solutions are available as full system product sales or as individual components,” said Dr. Elazar Rabbani, Enzo CEO. “We have launched this platform, now available for purchase, and are also processing tests at our CLIA laboratory, where we have current capacity of 2,000 COVID-19 molecular tests per day and can expand to meet market demand.”

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Enzo Biochem, Inc.