The Department of Homeland Security (DHS) is ready to begin testing and eventually procuring the next-generation of biological detectors that will eventually be deployed in major urban areas of the U.S. in both indoor and outdoor environments to quickly alert authorities of a possible release of potentially harmful and even deadly pathogens.

The DHS Office of Health Affairs (OHA) last week released a Request for Information for potential sources and market research for the upcoming test and evaluation and acquisition of the next-generation of BioWatch. The BioWatch program was first announced in 2003 and currently consists of the deployment of air samplers in over 30 major metropolitan areas in the U.S. for the purpose of testing samples every 24 hours for the presence of potentially harmful biological pathogens, such as anthrax. Most of the deployments are outdoors although some samplers are placed indoors.

The currently deployed samplers are manually retrieved every 24 hours for analysis by a local laboratory. The response time can take between 10 and 34 hours. Under the next- generation program, dubbed Gen-3, the deployed systems will not only collect samples but will test and analyze them throughout the day and then provide automated alerts through a network to the authorities.

The response time goal under Gen-3 is four to six hours, a significant time savings over the current system that would allow a faster response by health officials to deciding what measures need to be taken such as making public announcements and dispensing the appropriate antibiotics.

But Gen-3 is still in the future. In addition to issuing the RFI, OHA also issued an Acquisition Concept of Operations (CONOPS), which outlines the way forward for the Gen-3 acquisition plan. This plan will be refined based on the inputs OHA receives from industry through the RFI, Bob Hooks, deputy assistant secretary for Weapons of Mass Destruction and Biodefense at OHA, tells TR2.

Two-Phased Approach

Basically OHA is planning a two-phased approach to buying a Gen-3 system. Contingent on the responses to the RFI, Hooks is hopeful that a Request for Proposals (RFP) is released in the first quarter of 2009. There is also the possibility of an Industry Day prior to release of the RFP, he says.

Based on the responses, OHA next spring or early summer hopes to award multiple indefinite delivery, indefinite quantity (ID/IQ) contracts for system performance demonstrations leading to field testing in urban environments for Operational Test and Evaluation (OT&E).

The competition will be wide open, Hooks says. Currently three companies, IQuum, Microfluidic Systems, Inc., and U.S. Genomics, are wrapping up the development of their own Gen-3 systems under separate awards with the DHS Science and Technology branch (TR2, April 16 and March 19). That effort is called Bioagent Autonomous Networked Detector, or BAND.

In addition to those three firms, Hooks expects a team of Northrop Grumman [NOC] and Lawrence Livermore National Labs (LLNL) to offer their Gen-2.5 system, which had been expected to be ready already. Northrop Grumman’s effort is being developed under a contract through OHA called the Automated Pathogen Detection System and was expected to be an interim deployment under BioWatch until the Gen3 systems were ready.

But the Gen-2.5 technology has been a tougher development challenge than predicted so the “timelines are lining up between the Gen-2.5 and the Gen-3 systems,” Hooks says.

The automated BioWatch technology, whether Gen-2.5 or Gen-3, is a huge leap forward for biological detection and has never been done before anywhere, Hooks points out.

“We are on the cutting edge of technology development here,” Hooks says. “It’s not in DoD or DoE or anywhere else in the world. Nobody has this automated detection for multiple agents. And frankly this is a much more difficult technological development than I think any of us envisioned.”

In addition to the three firms developing Gen-3 systems under BAND and the Northrop Grumman/LLNL effort, Hooks says anyone else with a system that meets either the Gen3 or Gen- 2.5 BioWatch requirements is welcome to bid. However, OHA plans to do some upfront spot testing to weed out “junk,” he says.

The Gen-3 systems are supposed to be able to detect up to 20 agents and the Gen-2.5 system six agents.

Whatever systems are selected for purchase and deployment must cost less than the current technology and they will need a high level of sensitivity to the particular agents of concern and selectivity so that they can’t be spoofed.

“That is a very challenging problem to have level of sensitivity and also to only detect and alarm on the agents of concern,” Hooks says.

The first phase could last from six to 12 months and even longer if engineering changes are required to any of the selected units, Hooks says. “I’d like it to be as short as possible sow we want performers to meet requirements now.”

Congress has appropriated $34.5 million in FY ’09 for the testing phase of the program.

The second phase of the next-generation BioWatch effort is the start of production, which is slated to begin in early FY ’10, according to the Acquisition CONOPS. This is just an estimated start date and could slip based on the responses to the RFI as well as how the OT&E phase goes, Hooks says.

The current acquisition plan contains two options for moving forward. One is release an RFP only to the entities that demonstrated they can meet the Gen-3 requirements during OT&E and then award one or more ID/IQ contracts from which task orders will be issued. The other is to issue a competitive task order under the Phase I ID/IQ contracts and award contracts to one or more contractors to meet production needs.

Market Potential

The need is widespread. Hooks, making clear that he’s only expressing his opinion, believes the next-generation BioWatch systems should be deployed to more than just the 30- plus major metropolitan areas where current technology is sampling the air. Regardless of the ultimate deployment plans, Hooks says the federal government “cannot envelop the country with bio-detection equipment.”

But Hooks believes there will ultimately be more widespread deployments of this sophisticated equipment as private enterprises and state and local governments acquire it to reduce the risks associated with a biological attack. There will also be an international market for these systems, he says.

The reason for the limited indoor deployments of BioWatch now is that the slow response time makes it difficult in many applications to warn everyone who may have been exposed to an attack, especially if it is nearly two days since the attack occurred. A lot of people may have flown into and out of an airport in that time and moved on to far away places. But a shorter detect to alert window promised by the next-generation systems will make response more manageable, albeit still difficult, Hooks says.

As for costs, Hooks says DHS wants the per unit costs to be under $100,000 and the annual per unit operations and maintenance costs to be under $50,000.