The five-year agreement with MRIGlobal aims to enhance laboratory readiness and response for public health emergencies.

The Centers for Disease Control and Prevention (CDC) has awarded MRIGlobal an Indefinite Delivery/Indefinite Quantity (IDIQ) contract with a ceiling value of $148 million for diagnostic test development and production for emergency response.

The contract is designed to improve the efficiency and accuracy of laboratory testing and situational awareness during and outside of public health emergencies. The initiative aims to enhance laboratory quality, science, and data reporting by improving specific laboratory processes and data sharing between internal and external partners. These enhancements are intended to strengthen the national laboratory system to support response activities across multiple pathogen and condition types, including both current and novel threats.

Rapid Support for Diagnostic Development

In collaboration with global partners in diagnostic development and manufacturing, MRIGlobal will provide the CDC with rapid support for nucleic acid amplification test development, manufacturing, and deployment. These newly developed tests will address public health needs as determined by the CDC, ranging from novel point-of-need diagnostics to leveraging existing clinical diagnostics assays and laboratory networks across the US.

This work ensures that diagnostic tests can be developed, validated, and manufactured at scale to meet urgent public health needs in response to outbreaks of pathogens with pandemic potential. MRIGlobal has experience developing assays for infectious diseases and performing analytical studies for biothreat agents, respiratory diseases, antimicrobial resistance, tropical fevers, and gastrointestinal diseases.

Regulatory Readiness and Laboratory Capacity

The contract will utilize the team’s knowledge in research and development and regulatory affairs to ensure the CDC is prepared for outbreak scenarios. This includes establishing pathways for Emergency Use Authorization and 510(k) approval of developed tests. Furthermore, MRIGlobal’s CAP/CLIA accredited laboratories are designed to quickly onboard new assays and scale up when necessary to meet evolving needs.

“MRIGlobal is proud to have played a key role in the COVID-19 pandemic response by co-developing and validating diagnostic tests for SARS-CoV-2,” says Ian Colrain, PhD, president and CEO, MRIGlobal, in a release. “This award from the CDC not only acknowledges our past performance but also reflects their confidence in our ability to continue delivering high-quality work. Whenever called upon to address public health challenges of national importance, the MRIGlobal team brings the experience and expertise needed to respond effectively. We’re ready to take on this next challenge, and I’m confident our efforts will contribute meaningfully to pandemic preparedness.”

The IDIQ contract will be executed over five years through task orders using a collaborative approach that integrates in-house expertise with external partnerships to develop customized solutions.

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