Assay & Method Development
Develop and validate IVDs to support regulatory clearance
Development of Methods and Diagnostics
MRIGlobal develops and validates analytical methods and in vitro diagnostics (IVDs) that detect and measure pathogens, biomarkers, and other clinically-relevant targets with high sensitivity, specificity, and reliability. This is essential for supporting diagnostic accuracy, regulatory compliance, and dependable performance in applications where timely and accurate results are critical. Our expertise helps accelerate development timelines, navigate complex technical and regulatory risk, and enable market access for our customers.
Advancing Diagnostic Performance
Assay Design and Method Development
Design and optimize robust assays and analytical methods for scalable diagnostic applications.
Analytical Verification
Verify diagnostic performance through rigorous testing in support of accuracy, reliability, regulatory readiness, and clinical confidence.
Clinical Validation
Conduct clinical validation studies to demonstrate diagnostic accuracy, performance, regulatory compliance, and real-world utility.
Regulatory Strategy Development
Provide ongoing regulatory support for submissions, agency interactions and responses, compliance, and diagnostic commercialization.
Regulatory Submissions and Post Submission Support
Provide ongoing support, facilitating approvals, responses, compliance, and diagnostic commercialization.
Latest from the blog
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The Threat of Antimicrobial Resistance
There are potentially billions of different types of bacteria, and they’re found almost everywhere. Some are friends while others are foes. Studies show that kitchen sponges contain 45 billion bacteria per square centimeter. Another study suggests that your desktop has 400 times more bacteria than your toilet seat. And did you know that the average […]
Assay & Method Development Biosurveillance & Threat Detection Detection & Diagnostics -
Battling Antimicrobial Resistance
When an antibiotic treatment regimen is not successfully completed by a patient, the surviving bacteria have encountered the evolutionary pressure of the antibiotics that killed off a majority of their weaker population. These surviving, stronger bacteria are able to persist and continue growing inside the patient, eventually becoming strong enough to again cause symptoms. Because […]
Assay & Method Development Biosurveillance & Threat Detection Detection & Diagnostics -
MRIGlobal Tests First Non-EUA Flu and COVID-19 Diagnostic
CDC estimates that since 2010, except for the 2020-2021 flu season, flu has resulted in between 9 million and 41 million illnesses annually in the United States. Its symptoms can include fever, chills, cough, sore throat, and runny nose. And since it was first reported in March 2020, COVID-19 has totaled more than 104 million […]
Assay & Method Development Biological Threats Product Development
