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Clinical Lab Information

COVID-19 test
 

COVID-19 Multistep Approach

We are offering molecular diagnostic testing, and serological “antibody” diagnostic testing for the novel Coronavirus, and are working on repurposing a drug candidate in our pipeline for the treatment of COVID-19. Enzo utilizes its technological and research and development capabilities, manufacturing infrastructure strength and clinical diagnostic knowledge to develop products that address gaps in performance, cost, obtainability and safety. Enzo is one of few companies to incorporate a biotech entity, diagnostics division, and a CLIA certified clinical laboratory within the same company. Enzo has addressed challenges of the supply chain by manufacturing all of its critical reagents in-house. Enzo’s diagnostics equipment and kits are validated in its own lab prior to being released for sale in the marketplace for other labs and end users. Enzo is a fully integrated company with a comprehensive, end-to-end solutions for modern clinical diagnostics.

GENFLEX™ Molecular Diagnostic Modular System (for SARS-CoV-2 Detection)

Enzo’s Molecular Diagnostic Modular System consists of four modules that can be used together or independently depending on the requirements of the customer. They can be individually connected to third-party platforms or adopted as needed by other laboratories and healthcare entities. For example, for Sample Processing, one can utilize (a) the GENFLEX™ automated instrument for high-throughput testing, (b) semi-automated plate-based processing for lower-throughput or (c) manual tube-based processing for low-throughput. Below we have outlined each of these four modules:

Enzo’s Molecular Diagnostic Modular System

This modular system was launched based on EUA authorization submitted April 10, 2020. To validate the robustness of this modular system, samples were run comparing all of the interacting modules to each other and also to the standard reagents within the market. We validated the system using hundreds of samples, and during the trial period used a national laboratory as a comparator site sending the samples to their lab for confirmation of concordance.

Clinical trials continue on site to further expand the flexibility of Enzo’s modular open system.

The corresponding data within Enzo’s submission indicates that of the clinical samples evaluated, of the positive samples, 63% were spiked at 2x LoD and 37% were spiked at 10x LoD with synthetic SARSCoV-2 RNA. Positive and Negative Percent Agreement was 100% in patient samples.

  1. AMPICOLLECT™ Sample Collection Kit
  2. AMPIXTRACT™ Sample Preparation (Genetic Extraction from Patient Sample)
  3. AMPIPROBE® PCR Detection & Analytics
  4. GENFLEX™ Automated Instrument for Sample Processing

A. AMPICOLLECT ™ Sample Collection Kit

A key component of the workflow is the unique sample collection offered by Enzo. The Company has a three-pronged approach for sample collection. Each one of these requires validation and optimization on the GENFLEX™ system: (a) a conventional Dacron swab with conventional transport medium, (b) a conventional Dacron swab and collection tube with a proprietary inactivating transport medium, and (c) the AMPICOLLECT™ Inactivating Transport Collection kit which contains a cotton swab and collection tube with a proprietary medium for inactivating the virus upon sample collection. Enzo has conceptualized and designed all aspects of the AMPICOLLECT™ kit to address supply limitations and to provide safety and scale at an affordable price. In addition, the AMPICOLLECT™ Collection Kit enables a simplified collection from the mid-nasal area rather than the point where the nasal cavity connects with the throat. This makes the collection possible by anyone including by the patients themselves. By combining cotton swabs and mid-nasal collection with a virus inactivating transport medium, mass collection of samples for testing without the requirement of healthcare personnel is possible. At a minimum, the virus-inactivating transport medium will increase safety with regards to samples collected by a healthcare professional

  • Using validated standard cotton swab provides a path to dealing with the current supply backlog that has been present since the onset of the pandemic. Instead of relying on specialty manufacturing by a few global suppliers, Enzo’s kit uses a ubiquitous cotton swab for sample collection.
  • The kit, which combines the cotton swab with the Enzo virus-inactivating transport medium tube, ensures safety of collection as well as a more comfortable experience for the patient. Enzo’s solution enables the collection of a sample from the mid-nasal region as opposed to competitive industry kits that require upper nasopharyngeal collection that must be administered by a healthcare professional. Several media and industry sources claim that sample collection must be performed by a healthcare professional at the nasopharyngeal site to be effective. However, various technical publications support Enzo’s assertion that midnasal collection is sufficient for an adequate sample of the virus and surrounding cells from that area that would contain the virus. Using this premise, Enzo is running a clinical trial to demonstrate that coronavirus collection can be self-collected in this less invasive manner instead of by a medical professional. Initial data indicates a high level of correlation with the more invasive methods performed by the medical professional. Since the start of our trial, other entities have now begun a similar path to demonstrate the use of less invasive sample collection methods.
  • This self-administering enables far reaching, affordable, and rapid sample collection for testing as the collection is no longer dependent on the availability of healthcare workers.
  • The AMPICOLLECT™ collection kit with its proprietary collection solution (patent pending) inactivates any virus that is collected when the cotton swab is inserted into the collection tube. This feature increases safety for those handling the sample downstream (e.g., sample transport to lab, or lab professional running the test on the sample). This solution also ensures a sufficient amount of sample material for processing after collection with a cotton swab.
  • To further increase supply availability, the collection system is being validated for use with industry detection systems starting with Enzo’s proprietary GENFLEX™ system.
  • Enzo is able to scale AMPICOLLECT™ kits at affordable prices within the first few months of production, scaling rapidly to meet industry demand.

B. AMPIXTRACT™ Sample Preparation (Genetic Extraction From Patient Sample)

The AMPICOLLECT™ collection kit is used alongside of the AMPIXTRACT™ extraction and AMPIPROBE® detection kits. The AMPIXTRACT™ extraction kit is ideal for gently collecting the viral RNA from any patient sample. The isolated RNA is pure and ready for direct input to the target amplification process. The flexible kit design is adaptable to automated, high-throughput processing as easily as it is to manual processing. Here again, Enzo’s control of its supply chain comes into play enabling Enzo to provide this important kit at a low cost solution to the market.

C. AMPIPROBE® Amplification and Detection

These kits are designed for high-through-put processing, but can also be used in settings that only require the processing of a handful of samples. Regardless of processing scale, these kits are designed to provide high sensitivity testing. An internal control is built into the test kit to ensure accurate results and reduce the possibility of false negative results. For flexibility and mindfulness of supply, Enzo is validating these components to also work with other manufacturers’ collection kits.

D. GENFLEX™ Open Instrument Platform

GENFLEX™ Molecular Diagnostic workflow is a high-throughput, automated, and scalable platform for easy and accurate processing of common molecular diagnostic tests within a clinical production setting. Enzo has developed the specific reagents necessary for coronavirus detection that are compatible with this high-throughput platform. The Enzo SARS-CoV-2 assay optimized sample collection, extraction, and detection providing a flexible, yet accurate, approach to testing.

IgG/IgM Antibody Test

Serological testing, while it should not be the sole basis for diagnosing COVID-19 can play an important role in identifying individuals who have overcome an infection in the past and developed an immune response. Detection of the body’s immune defense response – “antibody detection” – is performed using the Enzo IgG/IgM ELISA assay.

Testing for the SARS-CoV-2 virus to determine if a patient is infected is only the first necessary step from a diagnostic point of view. The second, and potentially more crucial, test is to determine whether an individual has antibodies for the virus. The antibodies may be present based on a previous illness or exposure (even if asymptomatic). This “immunity” test may enable individuals to remove their masks and gloves, limit social distancing requirements, and begin returning to work. It also potentially limits the necessity of an anticipated vaccine to those individuals who do not carry these antibodies.

The Enzo high throughput kit for IgG/IgM antibody takes either a standard blood sample administered at a Patient Service Center (PSC), doctor’s office, or hospital or potentially a self-collected blood sample using an auto lancet finger-pricking device. The collected blood sample is then sent to the clinical lab to process, detect and analyze the sample. This allows for scalable testing to be performed under controlled conditions to deliver more accurate and more sensitive results than those obtained using the commonly available serology quick tests. Although the quick tests were initially thought to be a rapid and easy to administer solution, they may lack the required accuracy. As such, rather than providing an emotional relief, they actually could provide a false sense of security that endangers those around the patient who may wrongly believe and act as though they are no longer infected and are incapable of transmitting the disease.

  • Enzo 96-well ELISA plate test is performed in a clinical lab using common lab workflow.
  • Turnaround time is 24 hours and results are accurate and economical.
  • Easily scalable

Cytokine Storm Assays

To manage a Coronavirus patient that tests positive, the following inflammation patterns will continue to be important. It is often not the direct effect of viral infection on cells that creates problems for the patient but the body’s immune response to this virus that is thought to contribute to the cause of death. Reported clinical experience suggests that uncontrolled release of cytokines causes a “cytokine release syndrome” or “cytokine storm” in some COVID-19 patients, which is associated with respiratory decline and failure. Accordingly, early monitoring of inflammatory cytokine levels has been suggested as an important diagnostic tool for determination of administering early therapy in managing these patients.

Enzo is in the early stage of development of a diagnostic test for inflammation in COVID-19 patients which is based on an existing ELISA based “research use only” test for clinical purposes and a test that relies on a cytokine storm panel for monitoring including IL-1 (beta), IL-6, IL-8, TNF-alpha, and Gamma Interferon.

  • Enzo 96-well ELISA plate test is performed in a clinical lab using common lab workflow.
  • Turnaround time is 24 hours and results are accurate and economical.
  • Easily scalable