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  1. MCM Regulatory Science

Regulatory Science Research Tools

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Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile)
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Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile)

An important goal of FDA’s Medical Countermeasures Initiative (MCMi) Regulatory Science Program is to support medical countermeasure (MCM) development and availability by creating tools needed to assess MCM safety, efficacy, quality and performance.

Since its launch in 2010, MCMi has been funding intramural and extramural research to further MCM development, including building tools to help MCM researchers advance their products and help FDA reviewers evaluate MCM products for approval.

MCM-related regulatory science tools funded (or partially funded) by FDA include:

Learn more about these tools, and FDA's Technology Transfer Program on this page.

Cross-species immune system reference

In an MCMi-funded project, Stanford University collected data on human and animal immune responses, and used this data to create species-specific immune function maps. They overlaid the maps to highlight differences and similarities, and mapped immune responses to certain biothreat agents and possible MCMs in humans and animal models. Researchers created:

  • A reference database listing the cross-reactivity of more than 300 antibodies in five species of non-human primates in five blood cell types, and
  • A new web-based analysis platform capable of handling this immense volume of data, and providing programmatic access to the data and descriptive statistics extracted from it.

The data and analysis tools are available to the research community through a free, open-access website. Information from current studies to better understand Ebola and Zika virus will also be added to the data when available.

To request access to the antibody screening and cross-species datasets, please contact Zach Bjornson at [email protected].

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FDA-ARGOS

In an MCMi-funded expansion of the existing regulatory-grade reference database FDA-ARGOS (FDA Database for Regulatory Grade Microbial Sequences), FDA added reference sequences for Ebola virus, closely related filoviruses such as Marburg, and organisms that cause infections with symptoms similar to Ebola. In addition, MCMi funding allowed FDA to add genome sequencing of mosquito-borne viral pathogens, including Zika virus.

Working with other government partners, FDA acquired nucleic acids from these organisms, transferred them to sequencing facilities, and placed the resulting high-quality NGS data in a publicly accessible database.

This allows diagnostic manufacturers and FDA to use computer simulations to supplement actual testing to assess how well new diagnostics perform. This tool also allows the use of in silico reference analysis rather than live organism studies to assess the performance of a diagnostic device.

Contribute samples to FDA-ARGOS for free sequencing and analysis

The FDA-ARGOS team and collaborators are searching for unique, hard to source microbes such as biothreat organisms, emerging pathogens, and clinically significant bacterial, viral, fungal, and parasitic genomes. We aim to collect sequence information for a minimum of 5 isolates per species. Most-wanted organism list (PDF, 93 KB)

Access the FDA-ARGOS Database @ NCBI

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Zika virus reference materials for diagnostic developers

There are two primary blood diagnostic tests: nucleic acid tests that identify infection by confirming the presence of a virus’ genetic material (RNA) and serological tests that identify proteins (antibodies) produced by the body's immune system when it detects harmful organisms, such as Zika virus, in the blood. FDA has made available reference materials for both.

Zika reference materials for NAT-based IVD devices

Nucleic acid (NAT)-based IVD devices for viral RNA are the most sensitive method available to detect acute (current) Zika virus infection. However, the sensitivity of NAT-based methods may vary considerably across assays, and standardized reference materials are needed to facilitate product development.

One of the conditions of authorization for a ZIKV NAT-based IVD device under an Emergency Use Authorization (EUA), is for the EUA holder to assess traceability of their device with an FDA-recommended reference material. Traceability refers to tracing analytical sensitivity/reactivity back to a FDA recommended reference material.

To support fulfillment of an EUA condition of authorization to assess traceability, FDA has created the FDA Zika Virus Reference Materials for NAT-based IVD devices, which contains RNA from two current Zika virus strains in human plasma and three controls for blind testing.

The FDA Zika Virus Reference Materials are available upon request to Zika device developers who have a pre-EUA submission with the agency and have established the analytical and clinical performance of their assay. FDA will consider requests for material to be used solely for research purposes on a case-by-case basis. The reference material is made available without cost.

To request the FDA Zika Virus Reference Materials for NAT-based IVD devices, email [email protected]

Reference materials for Zika serological tests

FDA has also made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. Serological tests are especially important because there is often a small window when the virus’ genetic material is detectable. However, development of these types of tests has been particularly challenging because antibodies produced by the body to fight Zika virus are difficult to differentiate from antibodies produced to fight related viruses, such as dengue and West Nile viruses.

The FDA’s sample panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses. Although the panel is not for research purposes, diagnostic developers can use these samples to assess whether their tests can help distinguish recent Zika virus infection from infection with West Nile or dengue viruses.

Using the same serological panel to evaluate different devices available under EUA will help public health professionals compare the performance of different Zika virus tests.

The FDA panel is available to developers who have interacted with the FDA through the pre-EUA process and have devices that are in the final stages of validation. As of June 20, 2019, the FDA has granted EUAs to five serological tests for detection of recent Zika virus infection; one of these tests was authorized for marketing on May 23, 2019, and four others remain available under EUA.

Other developers interested in requesting a panel may contact the agency at [email protected]

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FDA-CDC Antimicrobial Resistance Isolate Bank

FDA and the Centers for Disease Control and Prevention (CDC) have collaborated to develop the AR Isolate Bank, a centralized repository of microbial pathogens with well-characterized resistance profiles.
 
The bank, which contains bacterial pathogens of national medical concern, provides a valuable resource to biotech and diagnostic groups in researching, designing, validating and evaluating next generation clinical tests, which in turn may support earlier diagnosis and development of more effective treatment options that can slow antibiotic resistance.

The AR Isolate Bank includes collections of bacterial pathogens that are associated with known or emerging resistance mechanisms. These isolates are available free of charge.

Manufacturers can request the isolates through the FDA-CDC AR Isolate Bank webpage.

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Catalog of Regulatory Science Tools to Help Assess New Medical Devices

In August 2020, FDA posted to our website a catalog of regulatory science tools to help assess new medical devices. This catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available.

The tools include:

  • Laboratory methods
  • Computational models and simulations
  • Physical and virtual phantoms

These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical technologies. We have provided references for each tool. These tools do not replace FDA-recognized standards or qualified medical device development tools (MDDTs). The FDA has not evaluated the suitability of these tools within any specific context of use.

View the Catalog of Regulatory Science Tools to Help Assess New Medical Devices

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FDA SARS-CoV-2 Reference Panel

The FDA SARS-CoV-2 Reference Panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The Reference Panel contains common, independent, and well-characterized reference material that is available to developers of SARS-CoV-2 nucleic acid-based amplification tests (NAATs) for which Emergency Use Authorization (EUA) was requested.

For more information, including comparative data and information on distribution, see: SARS-CoV-2 Reference Panel Comparative Data

FDA Technology Transfer Program

The FDA Technology Transfer Program team facilitates interactions between FDA scientists and collaborators, who develop and transfer technologies created in the laboratory. Learn more about FDA technologies available for licensing and collaboration, and view program contacts.

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