Northrop Grumman [NOC] has received a one-year, $9.6 million contract from the Biomedical Advanced Research and Development Authority to develop an automated, high-throughput diagnostic system to quickly determine if an individual has been exposed to a biological threat.
Northrop Grumman says its BioCHAMP-RSP (Confirmation of Harmful Agents by MassTag PCR-Rapid Screening Platform) will also be a flexible platform in terms of the range of threats it can detect, with initial plans to identify between 10 and 20 pathogens and be upgradeable to identify more than 30.
The system, which would likely be deployed to laboratories for post-event triage, would process samples taken from individuals who may have been exposed to a biological attack or pandemic outbreak to allow health officials to determine treatment options. Current technology that is used in laboratories for this purpose is manually intensive and relatively slow.
“This is a platform that allows high-throughput, flexible detection for helping our customers respond to bio-terror events,” Dave Tilles, director of the Homeland Security and CBRNE business unit of Northrop Grumman’s Electronic Systems sector, tells TR2. BioCHAMP-RSP will detect “infectious agents within hours, not days, as is currently the case,” he says.
In addition, the automated capability Northrop Grumman seeks to demonstrate with BioCHAMP would not only eliminate most of the manual processing done by lab technicians, it would provide an automatic identification whether a person has been infected by a pathogen, Danielle Dickinson, the company’s program manager for BioCHAMP, tells TR2.
Currently a lab technician to analyze and interpret the data to determine if a person has been infected, she says.
The award was made in September under BARDA’s Innovative Platform Technologies program. 3M [MMM] received a two-year, $6 million award from BARDA under the program to also develop integrated diagnostic capabilities for rapid, high-throughput surveillance and molecular diagnostics.
BARDA is within the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services.
Under its contract Northrop Grumman will develop and deliver some breadboard demonstrator units to evaluate the core detection technology and also produce a design of what a production system might look like, Tilles says.
One of the demonstrator units will be delivered to one of Northrop Grumman’s teammates, Wadsworth Center, New York State Dept. of Health, which is a public health laboratory that will assist with the development of the concept of operations and with verifying the technology, Danielle Dickinson, Northrop Grumman’s program manager for BioCHAMP, tells TR2.
Other partners on BioCHAMP include the Center for Infection and Immunity at the Mailman School of Public Health of Columbia Univ., which developed the original detection technology, the MassTag Polymerase Chain Reaction, and will continue to develop the technology. Agilent Technologies will supply its MassCode Tag technology, one of the reagents used in the system, and the back end detector, which is an integrated mass spectrometer. KAI Research is helping Northrop Grumman with planning for Phase 2 of the effort, which requires approvals by the Food and Drug Administration.
Phase 2 is not covered by Northrop Grumman’s current contract.
In addition to Northrop Grumman and 3M, BARDA also awarded six other contracts for different areas of development under the Innovative Platform Technologies program. The other contracts include:
- Infectious Disease Research Institute, $1.8 million in the base-year with $6.7 million in options over the following two years, to develop and evaluate adjuvant formulations to enhance influenza vaccine immunogenicity and cross-protection to make them more effective against novel viral strains that may cause the next pandemic;
- Pfenex, Inc., $10 million in the base-year with $8.8 million in options over the following two years, to apply its Expression Technology Platform to the development of optimized bioprocesses for high yield production of a stable candidate anthrax vaccine;
- VaxDesign Corp., $7.5 million in the base-year with $9.6 million in potential options in the following two years, to further develop its MIMIC platform, which is an in vitro human immune system mimetic designed to accelerate evaluation of candidate and stockpiled vaccine safety and effectiveness by supplementing animal testing;
- Rapid Micro Biosystems, $2.1 million in the base year and $4.7 million in potential options in the following two years, to address a critical issue in the time required for release of influenza vaccine after manufacturing by developing methods for accelerated sterility testing;
- Novartis Vaccines and Diagnostics [NVS], $12.5 million in the base-year with potential options worth $11.5 million in the following two years, to also address a critical issue in the time required to begin manufacturing of influenza vaccine against a newly identified strain by investigating techniques for the rapid development of optimized influenza seed virus; and
- PATH, $5.2 million in the base-year with $4.2 million in potential options in the following two years to test multiple formulation chemistries and strategies to increase the shelf-life of influenza vaccines, which has implications for the national vaccine stockpile as well as cold-chain requirements domestically and in developing countries.