The Department of Defense has a habit of funding new medical technologies. This week it awarded government contractor MRIGlobal $14.8 million for its proposed Sample-to-Sequence system to sequence the entire genome of pathogens and give a diagnosis within 24 hours.
As such, the emphasis on speed and the use of small a sample of blood or saliva is not new, for most of the new technologies in diagnostics emphasize those components, although it is too early to say if they have succeeded. The deal highlights other emerging trends, such as the FDA's growing role in regulating next-generation sequencing (NGS), and the use of databases to validate genetic information.
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| MRIGlobal CEO Thomas Sack |
"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," said MRIGlobal CEO Thomas M. Sack in a statement.
Under the three-year agreement with the Defense Threat Reduction Agency, MRIGlobal will test the system as part of an effort to obtain FDA approval and pursue commercialization. But the FDA's regulation of NGS technology is in its nascent stages and the form of future regulation is unclear. At a recent public meeting on the topic, the agency acknowledged that it cannot verify every piece of information genetic information or predictive data produced by NGS, and is seeking to move toward some sort of accreditation-based approach.
MRIGlobal says the genome from the sample will be compared against a database of pathogens. Indeed, the use of benchmark databases is another growing tactic. Israel's Pocared just won $15M in funding; it uses data analysis and artificial intelligence to analyze the optical characteristics of specimens, and compares them to a predefined database of those characteristics to identify and enumerate bacteria. (And the FDA discussed the need for and use of "gold standard" databases for regulatory purposes at its public meeting.)
MRIGlobal has a close relationship with the Department of Defense. The company recently hired the chief of the diagnostics, disease surveillance, and threat detection division within the Defense Threat Reduction Agency. Eric Van Gieson took on his new role as the company's senior director of biosurveillance programs this month.
- read the release