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Harvard Funded for Paper-Based Biodefense Diagnostic

The Defense Threat Reduction Agency (DTRA) has announced a new award to Harvard University for further development of a diagnostic platform for biodefense.

This award is a continuation of prior efforts funded by DTRA which began as part of a contract between Lawrence Livermore National Laboratory (LLNL) and Harvard University.

LLNL was one of three device evaluation laboratories performing for a larger DTRA project but was eliminated when that project down-selected to two laboratories. However, DTRA wanted to continue to pursue development of this diagnostic platform being evaluated at LLNL because of the low-cost and ease-of-use attributes of the diagnostic platform.

Additionally, this effort supported the development project between DTRA and India’s Defence Research and Development Establishment as outlined in a Project Agreement (PA) established in September 2012. Since the contract arrangement between Harvard University and LLNL is not continuing and DTRA is still interested in the work Harvard is conducting, as it meets the platform requirements identified in the PA, this award will establish a direct contract between DTRA and Harvard University.

This effort will further develop a rapid diagnostic platform for detection of Brucella and other biothreat agents and develop a diagnostic platform to achieve a Technology Readiness Level (TRL) of 5 to 6. This will be a two year contract with costs estimated to be $1,500,000. The work to be performed includes the following objectives:

  • Demonstrate the feasibility of detecting Brucellosis, design and develop a paper-based diagnostic platform, and assess the platform’s sensitivity and specificity.
  • Design and develop a fully multiplexed diagnostic platform capable of detecting multiple biodefense threat agents.
  • Design and develop methods for remote reading of the multiplexed platform.
  • Design and develop a lab-on-chip nucleic acid detection platform with on-chip sample processing and nucleic acid extraction capability.

The product Harvard is developing an in situ DNA synthesis strategy using paper as the solid support, including paper pre-activation and protection, direct DNA synthesis using paper as the solid support, and post-synthesis deprotection. This strategy does not involve any purification steps; yet it still demonstrated high sensitivity and specificity against target genes.

According to DTRA, this product presents a potential solution for human and animal health within resource-limited settings. The diagnostic tests developed from this technology are portable, easy-to-use, inexpensive, require no power or water and achieves results within minutes.

Currently, there is little in the way of paper-based diagnostics available and the two other platforms identified by DTRA’s market research were deemed significantly less mature than the Harvard platform, having not yet shown proof of concept for biological agent detection.

“Additionally, it has been found that developers have shown little interest in participating in development of biothreat agent diagnostics due to the limited market for the products, as demonstrated by several top developers of rapid diagnostic platforms not responding to RFPs released,” states the DTRA announcement. “Harvard University was the only developer identified with a paper-based diagnostic platform which includes both immunoassay and nucleic acid assay capabilities with the goal of developing a very low-cost end product which can be used in austere environments.”

To date, DTRA J9CB has invested significant funds in the development of this platform. $1 .1M was provided through the LLNL effort to attain capabilities to process whole blood samples, multiplex the paper-based platform, and further develop immunoassays for Brucella diagnostics.

Prior to this investment, $9.0M ($3.5 from DTRA) was invested into this technology through a program jointly funded with DARPA to determine the performance characteristics of the platform and develop nucleic acid detection assays.

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