The Department of Homeland Security’s Office of Health Affairs (OHA) plans to move quickly from demonstrations of automated bio-detection systems to contract awards that would ultimately lead to operations tests of those systems next year, the official in charge of the program tells TR2.
In late May OHA released the Request for Proposals (RFP) for limited production and testing in Chicago and New York City of the Gen-3 systems under the BioWatch program. The Gen-3 systems, if they work in operational environments, will provide autonomous monitoring and detection of bio-threats and will replace existing Gen-1 and Gen-2 systems that are labor intensive and slow to warn of potential threats.
Companies interested in competing for Gen-3 work will submit their systems to OHA for a demonstration early next month that will determine whether they are suitable for contracts to move into a test and evaluation phase.
“We’re not going to be waiting for months on end for them to get it right,” says Bob Hooks, deputy assistant secretary for Weapons of Mass Destruction and Biodefense at OHA. “We need to get in there and test it and validate that it works well and start deploying as quickly as possible. So I expect it to be a fairly short evaluation period before we make the awards.”
After that, Hooks is hoping initial testing begins before the summer is out.
“I am urgent,” he says. “I am in a hurry to do this right and also get into testing.”
Release of the RFP kicks off a potential two phase procurement plan for Gen-3. In the first phase multiple contractors are expected to receive awards for systems that will allow OHA to test mature bio-detectors in the laboratory and also in “operationally relevant” scenarios to determine whether the systems are suitable for eventual procurement and deployment, according to the 75-page RFP. Field testing in phase one is projected to be completed by the end of June 2010.
The second phase would be covered under a separate RFP. The results of phase one will help determine whether the second phase, which would be a separate procurement, is implemented. Phase two would consist of operational test and evaluation of the Gen-3 production detectors, transition to full rate production, deployment, operations and maintenance.
Potential bidders for the second phase of the Gen-3 effort are not required to participate in Phase One although they would be required to demonstrate that their proposed technology is ready for low-rate initial production, according to the RFP.
DHS says awardees in Phase contract could receive a maximum of $37 million each over three years if all options are exercised. DHS has $29.3 million available for the first year.
Two of the leading contenders for Gen-3 include Northrop Grumman [NOC] and Microfluidic Systems, Inc. (MFSI). Based on responses to an earlier Request for Information, a subsequent Industry Day, and his own knowledge of the capable firms, Hooks is “optimistic” that there are more than two potential solutions currently. He’s also “hoping to be surprised that somebody comes in with a new innovative solution and just hasn’t played their cards yet.” Industry officials expect ICx Technologies [ICXT], which has strong capabilities in bio-detection, to compete for Gen-3 as well.
Northrop Grumman had been involved in an advanced BioWatch system called Gen-2.5. In that pilot program in New York City, OHA deployed six of the company’s Automated Pathogen Detection Systems (APDS) for automated collection, detection and analysis of aerosol samples several times a day. The system was more expensive to operate than what is required under Gen-3 and also doesn’t analyze the range of pathogens OHA is looking for, Hooks told TR2 last fall (TR2, Nov. 26, 2008).
Northrop Grumman’s APDS Pilot Ends
Recently OHA, in conjunction with public health officials, discontinued the APDS pilot after finding “signatures that we were looking to detect we’re not as reliable as we wanted,” Hooks says. The systems had been operating for about 18 or 19 months but only recently began having issues, he says.
Hooks says the APDS systems were strictly for pilot testing purposes and that OHA is looking for more advanced systems in Gen-3. The purpose of the pilot was to learn and DHS is analyzing why the APDS systems began to have problems and make sure any lessons are incorporated into the Gen-3 effort, he says. The APDS units were in a side-by-side comparative analysis with Gen-1 and 2 systems, which require manual retrieval of samples that are collected. Hooks says that public health officials are collecting samples from the Gen-1 and 2 systems that were paired with the APDS on a more frequent basis now to provide a better monitoring capability.
Overall Hooks is happy with the APDS deployment in New York.
“We learned so much from that in the BioWatch program as well as New York City learning how to operate an automated detection system where you were providing the indications to the public health officials in the city on a wireless PDA and their ability to interpret that signal and take appropriate action if necessary,” Hooks says. Still, APDS was a prototype originally developed by Lawrence Livermore National Laboratory and for Gen-3 he expects more mature systems to be offered by industry.
MFSI has developed its automated bio-detection system under the DHS Science and Technology Directorate’s Bioagent Autonomous Networked Detector (BAND) program for several years. The company is the only one of three firms under BAND with a system that was contracted to move into a field testing. The company’s systems are networked and running in those testes Allen Northrup, MFSI’s CEO, tells TR2.
“For us the technology has left the station and is going quite well,” Northup says. “So we think we are in a very strong position.”
Going into the Gen-3 program Northrup says he’s not sure yet whether MSFI will take a prime contractor role or not. On BAND, the company is teamed with Hamilton Sundstrand, a division of United Technologies Corp. [UTX], which provides systems and expertise for transition to production and operational support, and Applied Biosystems, which provides the assays used to detect harmful pathogens. Applied Biosystems’ polymerase chain reaction assays are used in Northrop Grumman’s Bio-hazard Detection System that screens for anthrax as U.S. Postal facilities.
IQuum and U.S. Genomics, the other two companies in BAND, were not awarded work to move into field testing. U.S. Genomics, whose technology is deemed a higher risk approach, is doing laboratory testing under BAND although its system is “one or two iterations” away from being ready for field testing, David Hoey, vice president for business development at U.S. Genomics, tells TR2. In the lab the system is doing automated detection with “sample in, answer out,” he says.
U.S. Genomics’ BAND money will run out at the end of FY ’09. The company has received funding from a private investment firm to develop its technology for work on infectious diseases in humans and possibly pursue other opportunities in bio-defense with the federal government, Hoey says. DHS S&T recently announced it plans a program called Next Generation Sample Preparation and U.S. Genomics plans to pursue this as well, he says. However, the company still wants to find money to continue testing its BAND system, which while not based on the more mature PCR technology, has the potential to detect for a wide range of bio-threats, including “over-the-horizon” threats, Hoey says.
Multiple Solutions?
While there likely will be two or more companies that compete in the Gen-3 “fly-off” next year, Hooks says ultimately more than one system may be what’s needed to meet the Gen- 3 requirements for deployment.
“We don’t look to a single solution necessarily providing all the needs that the country has,” Hooks says. “There may be multiple options we can put together in a more comprehensive network and so I’d like as many options so that I can evaluate the ingenuity and innovativeness that the companies can bring to the table.”
The operational test period that will help pave the way for Phase Two of the Gen-3 program had been expected to get underway this summer but Hooks says the challenging nature of the technology–putting a lab inside a box and networking it–calls for a more deliberate approach. Key to that approach is the partnership OHA has with state and local officials on BioWatch.
“And it became clear that I needed to have a comprehensive effective test plan that included them [state and locals] as well as [the DHS] Center for Disaster Preparedness and others so that they have a level of comfort with the system to successfully work through this process. The state and local officials are the ones who operate this system on a daily basis. And the message I received from them is ‘Bob, I want confidence in this system. You’re putting me in a decision to make decisions, I want confidence.’ And I fully support that. I want to be able to look all of our city officials in the eye and say, ‘If my family were in your city I would be using this system.’ And so with that kind of approach that requires me to step back and ensure are we doing everything that the nation needs to ensure that we are getting the most effective equipment out there in the field.”