Enzo Biochem launches COVID-19 diagnostic test under FDA Emergency Use Authorization

April 30, 2020

Enzo Biochem announced 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 is utilizing its technological and research and development capabilities, manufacturing infrastructure strength and clinical diagnostic capabilities to provide products that address gaps in performance, cost, supply obtainability and safety. Most diagnostic platforms offered by others are ‘closed’ systems and have no flexibility with regards to adoptability for other infectious agents, have limited supplier relationships, and have no direct connection with the patient or the event. These underlying problems have manifested themselves in the current COVID-19 crisis. Enzo’s Comprehensive COVID-19 Program showcases Enzo’s ability to respond to the current challenges plaguing the healthcare market.

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.

“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.”

Leveraging Enzo’s expertise in diagnostics technology, the new COVID-19 test features improved scale, sensitivity, and more relevant positive control materials. Enzo’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. Enzo consulted with the U.S. Centers for Disease Control and Prevention on the implementation of these enhanced test features.

The well-publicized supply chain shortage of swabs, reagents, and other collection materials, compounded by the limited sample processing and molecular analytic capabilities available, has created a national crisis. Widespread testing is needed to learn the virus’s behavior, and properly manage its spread. Testing just 10 percent of the U.S. population only once would require 33 million tests.

Furthermore, serial testing should be provided to those who have previously tested positive and to people who are regularly exposed to the virus, such as healthcare providers and emergency personnel. Any attempt to reopen the economy requires the ability to distinguish between infected, recovered, and non-infected individuals from within the total population. An improved test would be both widely available and allow for future self-collection by the patient, thereby reducing the risk to clinical workers.

Enzo’s GENFLEX Molecular Diagnostic Modular System (for SARS-CoV-2 Detection) includes the following components currently available or under development: 

a.            AMPICOLLECT Sample Collection Kit - a proprietary sample collection kit to overcome supply limitations and enable patient self-testing (In clinical trials)

b.            AMPIXTRACT Sample Preparation (Genetic Extraction from Patient Sample) (Available)

c.             GENFLEX Automated Instrument for Sample Processing (Available)

d.            AMPIPROBE Amplification and Detection (Available) 

Enzo’s solution includes a complete molecular diagnostic kit optimized for use on the proprietary GENFLEX molecular diagnostics platform and compatible with manual or alternative platforms. 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. The GENFLEX and manual kits are now available.

In addition, as part of Enzo’s Comprehensive COVID-19 Program, the Company is developing: 

•             IgG/IgM Antibody Test (for immunity detection) - Immunoglobulin G (IgG) / Immunoglobulin M (IgM) on an ELISA (enzyme-linked immunosorbent assay) plate for detecting and quantifying antibodies to identify the individuals who were infected with, or without, symptoms.

•             Cytokine Storm Immunoassay (for inflammation monitoring) - Commercialization of Enzo’s full inflammation panel including the detection of Interleukin 6 (IL-6) levels (currently available for Research Use Only) to enable administration of immunosuppressant to treat Coronavirus when a patient demonstrates a hyper immune response.

•             Potential use of Enzo's Drug Candidate SK1-I (for the Prevention and/or Treatment of Cytokine Release Syndrome and Respiratory Failure in COVID-19 Patients) - Therapeutic studies based on a promising proprietary drug candidate (SK1-I) which may have potential in the treatment of COVID-19 as it has already demonstrated immunosuppressant response in a recognized, chemically-induced animal model of Lupus and has previously passed preliminary toxicology studies. 

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