Assay Development

MRIGlobal has developed, characterized, and fielded hundreds of novel and established testing assays for the detection of bacteria, viruses, parasites, toxins, and host biomarkers in a diverse array of  matrices. These programs have been executed for CDC, BARDA, FDA, NIAID, private commercial clients, the Department of Defense, and the Intelligence Community. These include assay types such as molecular, immunological, and microbiological assays to cover the spectrum of disease-causing agents and host markers.

MRIGlobal has developed and submitted dozens of novel molecular diagnostic assays to the FDA for approval. We work closely with our clients to determine the target in vitro diagnostic assay requirements as appropriate for intended use, patient clinical presentation, and treatment decisions. MRIGlobal has experience working closely with the FDA to bring clinical assays through the 510(k) approval process.

MRIGlobal has the capability to design molecular assays using both proprietary and open source bioinformatic analysis tools. These tools can be used to identify targets for detection and diagnostic assays for infectious agents and/or host biomarkers. Our expertise ranges from database creation and manipulation to biomarker identification and DNA/RNA sequence analysis.

MRIGlobal possesses and manages extensive collections of infectious disease agents from which to compile reference panels, controls, and qualified QC materials and targets for novel client assay development efforts. This includes BSAT pathogens, ESKAPE pathogens, and Respiratory and Enteric Panels.

We perform assay feasibility and optimization studies for both clinical and R&D assay development. MRIGlobal designs assay reagents, protocols, and methods under ISO 17025, GLP, or CLIA standards to optimize assay sensitivity and specificity. Our clinical assay development efforts are aligned with FDA best practices, and our expertise includes assay design development planning, regulatory planning, assay optimization, assay verification and validation, risk management plan, and training, all under a Quality Management System (QMS).

MRIGlobal has extensive experience building assays for a collection of different clinical sample types such as blood, urine, and sputum. Each of these sample types presents different challenges for efficient DNA/RNA extraction and removal of inhibitory substances.