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Device and Assay Development for Diagnostics and Detection

In Vitro Diagnostics

At MRIGlobal, we provide needed expertise to expand and accelerate delivery of high quality clinical diagnostic products. Anyone seeking diagnostic and detection device development can trust our experience. We also perform validation testing on those same devices and assays. 

We offer government and commercial clients services including assay design, assay development, analytical verification, and clinical validation through regulatory submission. We provide:

  • extensive research and product development expertise  
  • facilities, analytical services, clinical trial site, and clinical trial services and support
  • regulatory guidance to support FDA, EUA and 510(k) submission filings.

MRIGlobal and in vitro diagnostics

When it comes to in vitro diagnostics (tests done on samples taken from the human body), our capabilities cover a wide range. We are adept with development of cutting-edge molecular and immunological assays focused on emerging highly infectious disease as well as the advancement of novel, highly sensitive diagnostic assays.

MRIGlobal’s emerging infectious disease services span all stages of the in vitro diagnostic product development process, beginning with research and development through product clearance and launch.

Our infectious disease diagnostics R&D and in vitro diagnostic product development capabilities include, but are not limited to:

  • Development of methods, platforms, and molecular and immunological assays
  • Turnkey, outsourcing solutions for commercial and government clients
  • Accelerated product development through analytical verification and clinical validation phases

Trust in our subject matter expertise

A program manager as well as a principal investigator lead each project MRIGlobal takes on. This approach ensures projects stay on track while having the appropriate guidance from the scientists in the field.

As one of the two leads, our principal investigators are technical subject matter experts. They make all of the decisions related to the technical side of the project and they are the ones designing the studies.

The program manager is in charge of the schedule, budget, and resources. They will also be a key point of contact between customers and the project team. Program managers work closely with the principal investigator to ensure they stay within the scope and that the resources needed for the project are available. 

Our objective subject matter experts understand all aspects of phase appropriate method validation and testing. We conduct analytical studies in alignment with FDA and CLSI guidance, and clinical testing following good clinical practices (GCP). 

Flexible enough to meet your needs

There is no limit to what we can accomplish at MRIGlobal, so no matter the size of your company we can help with diagnostic and detection device development around the world. Sometimes, we partner with a company from initial conceptualization to creating multiple prototypes, testing and optimizing them, all the way through to the regulatory submissions. 

Other times, we partner with large companies who have a great deal of in-house capabilities, but need multiple sites for validation studies. MRIGlobal stands apart from the crowd of CROs with our available Biosafety Level 3 containment laboratories for handling infectious diseases.

What does Biosafety Level 3 mean?

Our Biosafety Level 3 laboratories’ availability is often a game changer for companies working with infectious diseases. Biosafety Level 3 is applicable to laboratories where work with indigenous or exotic agents may cause serious disease because of exposure by inhalation route. The personnel in these labs must undergo specific training for the handling of those agents and must be supervised by scientists who are experienced with the agent. 

The facility management of our Biosafety Level 3 spaces also ensures all personnel demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the lab facility. 

Benchtop and field-forward devices

MRIGlobal has vast experience with both government agencies and commercial diagnostics companies developing small, benchtop instruments and ruggedizing devices for field-forward environments. MRIGlobal has expertise in developing CLIA-waived or at-home diagnostic testing solutions. Our problem-solving capabilities allow us to engineer large benchtop equipment into something small, rugged, and portable. Nothing highlights that quite as well as our incredible Mercury Lab portable laboratory.

A new generation of portable lab capabilities

The Mercury Lab is a single-person portable laboratory workbench designed for point-of-need operations. With this product launch, MRIGlobal ushered in a new generation of field-forward laboratory capabilities. Samples for advanced molecular diagnostics, biosurveillance, and forensic testing can now be processed on site without the need for a pallet full of equipment. This logistical streamlining dramatically reduces the time to acquire an actionable result, and safeguards the quality of the sample by eliminating the need for extended transport.

Mercury Lab is a single, lockable, grab-and-go case that can be wheeled through an airport and checked as luggage, thrown in the back of a pickup truck, or even strapped to the back of a motorbike. It can be set up on site in a few minutes, and be packed up just as quickly. It includes power management architecture, cold-chain storage, computational capacity, a stable workbench, biohazard waste disposal strategies and more. Mercury Lab brings a fully operational laboratory to the sample.

This small, tough device features the following capabilities:

  • An ergonomic, stowable, sterilize-able laboratory workbench with spill-control features and an LED overhead work light
  • Shelf storage for pipettes and laboratory workflow consumables (e.g., pipette tips, ambient reagents, etc.), configured for easy-access while working at the laboratory bench, contained in a removable backpack
  • Integrated computational hardware: Intel NUC8v5PNK w/ 64 GB DDR4 RAM and 2 TB PCI.e M.2 SSD, linked to a Nvidia Quadro P4000 GPU card with 1,792 CUDA cores. Configurable with choice of OS (i.e., Linux or Windows) and comes standard with MRIGlobal’s PanGIA real-time metagenomics taxonomy classification software pre-installed
  • Computer is controlled via wireless bluetooth keyboard/mouse and 15.6” HD display monitor mounted above the workbench
  • Custom integrated cooling to prevent computational-induced overheating
  • Optional LTE Mobile Broadband modem (user-supported service contract)
  • Integrated pure-sine-wave AC/DC inverter and hash filtering to allow for safe, effective operation directly from a 12V lead-acid car battery (either standalone, or from a running vehicle), or grid-based power when available. Connected to a DPST system shut-down switch. An integrated battery-power monitor advises on available charge.
  • Two U.S. standard 120V power outlets (or optional 230V E.U. configuration) and two USB 3.0 outlets (power only, in addition to data outlets from NUC)
  • A bracket to house and secure an additional user-selected storage option—choose from; 4 L CREDO cold-chain cube (4*C or -20*C—up to 96 hours of stable, un-powered cold storage), or additional soft-sided, adjustable shelving unit
  • An included, wrap-around windscreen to moderately shield exposed workbench sides from wind and other elements
  • Oversized 4” wheels for travel over bumpy city sidewalks and field terrain

MRIGlobal: A small CRO with huge capabilities

Clients are often surprised by the breadth of services MRIGlobal offers as well as the depth of our expertise. Sometimes a client comes to us for validation testing after their product is developed and realizes we also do assay design. Usually this leads to that same client partnering with us again for more services once they understand how much we can actually help. 

Even beyond our Biosafety Level 3 laboratories, sub-zero storage, testing and development capabilities, MRIGlobal prides itself on being a flexible partner in the contract research field. If you come to us with a challenge we haven’t met yet, we will figure out a way of meeting it. 

Looking forward, learning from the past

With the COVID-19 pandemic came a great deal of change. The emergency use authorization process utilized for the diagnostics and therapies/vaccines had never been used to that scale before. The speed with which things needed to move through the FDA to properly respond to the pandemic required a culture shift both at the Agency and MRIGlobal. 

Our scientists believe this will have a lasting impact on the regulatory field as well as device developers because now this process is in place. “I think we are being more forward-looking,” said principal scientist Jennifer Stone. “It’s not just that we are going to make a product for COVID-19, but we are making a process and a pipeline so we will be ready to tackle the next ‘COVID’ more quickly and effectively.” 

“MRIGlobal’s extensive experience in the regulatory process positioned us very well to respond to the rapid pace the FDA and industry was setting. It allowed us to respond quickly to the needs of the government and our commercial clients around the world,” said Senior Advisor and regulatory SME Michaela Hoffmeyer.

Getting started with MRIGlobal

Contact MRIGlobal and get started with developing your diagnostic platform, analytical verification testing, clinical validation, and regulatory support.  

As a not-for-profit contract research organization, we have proven ourselves as an objective partner driven to make our clients’ products more successful. We specialize in defense, human health, pharmaceutical sciences, clinical diagnostics, energy and environment, agriculture, and global health.

To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.

Project Quote Tool

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