MRIGlobal offers a broad portfolio of infectious disease diagnostic capabilities across the development lifecycle, from initial feasibility and development studies, to testing, validation and verification, to clinical comparator testing and preparation for FDA filing. We bring the needed experience to partner with organizations seeking to improve and innovate in the diagnostic space, making us an ideal partner in disease diagnostic development and FDA filing.
At MRIGlobal, we are “technology agnostic,” meaning we don’t endorse any one product; we are here to facilitate and ensure quality products and services get to market.
MRIGlobal’s disease diagnostics mission and scope
The history of MRIGlobal is 75 years of advancing knowledge and improving our world through research and engineering contributions. When it comes to disease diagnostics, our mission is: Innovate and accelerate high-quality diagnostic technologies for the advancement of disease detection and diagnostics and global health missions.
The scope of our portfolio for infectious disease diagnostics includes:
- Assay design and development
- Device development
- Analytical verification studies
- Clinical validation studies
- Independent platform evaluation
- Flex studies and usability testing
- Device trial site
- Clinical reference testing
- Regulatory submissions (EUA, 510(k), IVD-R)
- Biosafety training and lab development
Diagnostic assays are often the same style tests as those used in vaccine development but are for the intended purpose of identifying the source of a patient’s illness to enable the initiation of appropriate treatments by healthcare professionals.
What is the scope of MRIGlobal’s disease diagnostics capability?
According to Kristine Werking, Portfolio Director for Disease Diagnostics, MRIGlobal has a broad range of clients and programs as well as various scope elements.
“The foundation of clinical diagnostics or disease diagnostics, as we’re executing in the here and now, is the infectious disease pipeline,” Werking said. By establishing a program and “pipeline” of steps and elements, the future has a framework to build on when faced with infectious diseases.
Our efforts with both commercial and government clients can go from “soup to nuts” with early identification of assay targets and molecular detection to developing the assays and conducting the testing and taking it through the verification pipeline.
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 at developing cutting-edge molecular and immunological assays focused on emerging highly infectious diseases and 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
What to ask about the development of infectious disease assays
MRIGlobal has evolved over the years, as has our ability when it comes to consulting for disease diagnostic development and FDA filing. You want to be sure you’re partnering with the right team when you’re tackling the FDA clearance pipeline. There are some key questions project owners should ask when considering a partner in preparing and filing for FDA approval
- How much depth and experience do you have?
- How many submissions have you supported?
- How many products have you gotten through approvals?
- How quickly can you ramp up scale?
At MRIGlobal, what we offer is added bandwidth to accomplish whatever is needed. In addition to top-notch facilities, we have a track record of success and a reputation for being flexible and getting the job done.
What does quality mean?
Quality FDA consulting for medical device development means thoroughness and innovation. We are able to bring a new approach from a regulatory standpoint. We have experience knowing the level of testing required or the approach that might be more successful with the FDA. Many projects are owned by business-minded people with great ideas but no technical expertise: That’s where MRIGlobal comes in.
Why is FDA guidance for disease diagnostic development needed?
There are several reasons companies seek diagnostic development. Even huge conglomerates with a very mature, robust system may lack the bandwidth or resources to complete the process because they have more products they’re attempting to get to market than they have resources for.
We have the understanding, the pieces in place and the resources to not only get through the challenges of FDA clearance but to execute at a higher volume than many clients have the capacity for. The leadership we offer provides considerable value to any project, and we aim to act as an extension of our clients’ teams.
What are the deliverables for these services?
The deliverables when we act as your FDA consultant are in the form of reports, content, or data to the regulatory submissions or marketing materials. We can also provide a third-party agnostic set of comparison data. Expanding regulatory claims as part of testing is another deliverable we offer, as is data generation to update, for example, the shelf life of a medication or device.
Specifically, we generate pre-submission packages or filings of the FDA. We also submit and contribute to product filings. A major focus of many of our projects is 510(k) submissions, and we can generate or provide content for de novo submissions as well.
510(k) submission expertise
The most common form of premarket submissions to the FDA for legal marketing of devices in the US is the 510(k) premarket notification submission and the premarket approval (PMA). When generated correctly, a 510(k) submission demonstrates the device is at least as safe and effective as a legally marketed device that isn’t subject to PMA. We know where to find the most appropriate predicates that will make and support your substantial equivalency claims.
Supporting de novo submissions
Novel devices of low to moderate risk without valid predicate data go through the de novo pathway for FDA submission. MRIGlobal works with the developer and the FDA to determine what option for de novo submission will be best. Companies have two options; submitting a 510(k) to the FDA and making the de novo request upon receipt of a “Not Substantially Equivalent” determination, or submitting a de novo request without first submitting the 510(k).
We assess which pathway would be ideal based on the device and the data you’re measuring against and then chart the path for the smoothest road to FDA regulation.
MRIGlobal, the FDA consultant you can count on
The road to FDA regulation is not always straight. The FDA may reject the submission or ask for additional data before approving the device for market. We don’t just walk away after we file the submission. We continue to provide guidance and data to achieve the goal we started with.
The diversity of expertise among MRIGlobal scientists means we can connect the dots in ways other CROs can’t. We have the therapeutics side and the medical research side looking into biology and chemistry. We’ve got pharmaceutical sciences looking at synthesis and drug formulations and all relevant components. Our biosurveillance core is yet another piece to the puzzle, giving us a much broader picture of understanding when working with infectious disease assays and guiding devices successfully through FDA clearance.
COVID-19 impact on infectious disease assays
In early 2020, a huge portion of the scientific community shifted focus to learning about, treating, and preventing COVID-19. In the same way COVID-19 accelerated the vaccine development process, it pushed the world of infectious disease assays and testing devices years ahead. Scientists and researchers built upon existing research and technologies intended to push point-of-need care and mobile capabilities.
“Another aspect of the process that is getting attention is recognizing the ‘unknown unknowns,’” said Werking. “The goal is identifying the next pandemic before it is a pandemic. How can we leverage the power for rapid development, and how do we use it to control and prevent these events?”
Do portfolio managers “lead” or “follow” at MRIGlobal?
Portfolio managers at MRIGlobal are set apart by their ability to act as both leader and follower simultaneously. Depending on the client’s needs and experience, portfolio managers can simply execute the plan within the determined timeline, or they can make recommendations. Our ability to go above and beyond in this way is what truly sets us apart from other contract research organizations (CRO). Our ability to acquire samples to support analytical and clinical testing is unmatched. Sometimes clients come and want to pay us to do one thing, but we can let them know a better direction to move in. Our responsibility is finding the best path through FDA clearance.
We are a non-profit, but much of our staff have commercial experience, which means employees have a good understanding of a company’s goals and keep things on schedule and within budget.
Constantly evolving our capabilities through smart recruitment
At MRIGlobal, we are always looking for passionate people to join our team. Whether we need to expand into a new subject matter to better accommodate a project, or if we’re simply building upon our existing expertise in a field, we keep an eye out for talent.
Our work environment is diverse, unique, and ever-evolving; so are the people who work here. Though our contributions to science drive us, we realize that time outside of the workplace is important for all of us. We believe in a healthy work-life balance, and we pay attention to what increases quality of life and what doesn’t.
Choose MRIGlobal as your FDA consultant diagnostic development
Contact MRIGlobal and get started on your FDA clearance pathway. When MRIGlobal is on your side, you benefit from a trusted partnership. We are committed to getting our clients to the finish line. Your goals become our goals, and we work toward them with dedication and commitment using the scientific background and expertise only we bring to the table.
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.
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