MRIGlobal today announced that it has been awarded a $14.8 million contract to develop an end-to-end next generation sequencing system for clinical diagnosis of infectious diseases.
MRIGlobal's proposed Sample-to-Sequence system will take clinical samples (blood or saliva, for example) and generate high-quality whole genome sequences of bacteria and viruses. The diagnostic tool will be able to identify a broad range of human pathogens, from a single sample with particular emphasis on emerging pathogens and those not identifiable by available rapid diagnostic methods.
With the Sample-to-Sequence system, a clinician will send a single sample to a laboratory for sequencing. The genomes uncovered in the sample will be identified against a developed database of microorganisms capable of causing infectious diseases.
"This is a revolutionary approach," said Thomas M. Sack, Ph.D., President and Chief Executive Officer of MRIGlobal. "Today, each test requires a unique sample, and certain procedures such as blood cultures can take a week to generate data. Sample-to-Sequence will provide rapid answers within 24 hours, giving actionable data to improve diagnoses and lead to better public health outcomes."
The three-year contract was awarded by the Defense Threat Reduction Agency. The program will generate clinical data that will be used to apply for FDA approval and ultimate release to the commercial market.
MRIGlobal will provide analysis of technology and selection of key components addressing sample preparation, next-generation sequencing, and bioinformatics. MRIGlobal will lead the systems engineering and integration, and testing, in preparation for regulatory reviews and the post-contract commercialization of the system.
"MRIGlobal will integrate a diverse team of experts from leading commercial and government entities in this development," said Michael Cassler, Ph.D., Director of MRIGlobal Molecular Diagnostics. "We will deploy a 'Gold Standard' pathogen database to generate diagnostic calls as well as draft genomes and antibiotic resistant profiles from the samples."
"The ultimate goal is a new tool that clinicians worldwide can use to quickly and accurately identify deadly infectious disease-causing microorganisms, allowing for more rapid and accurate treatment to ultimately save lives," Cassler said.