After six years of development, a technology firm says it has created what has been a holy grail for the Department of Homeland Security’s BioWatch program: a laboratory in a box.
PositiveID, a Delray Beach, Fla.-based company said its M-BAND — microfluidic bio-agent autonomous networked detector — has the ability to collect and detect a variety of airborne pathogens and toxins in a self-contained unit and transmit the results to smartphones, or other devices, every three hours.
The current BioWatch program depends on collection devices positioned in almost two dozen cities or at special events. Its filters grab pathogens and toxins from the air. The sample must be gathered on site by technicians and then taken to a laboratory to be examined. The results can take anywhere from 24 to 36 hours.
The long-standing goal for the third-generation BioWatch3 program has been to do all the processing at the site, send the results to a headquarters and, therefore greatly reduce the logistical burden and cost of the program.
Lyle Probst, PositiveID’s president, said the M-BAND can deliver results every three hours and therefore greatly reduce the amount of time and money needed compared to BioWatch’s previous two generations.
Now that the work is complete, the question is whether the program is going to move forward.
A September 2012 Government Accountability Office report recommended that DHS “articulates a clear approach with a series of measurable steps and initiatives to enhance the nation’s biosurveillance capability.”
DHS is currently in the process of producing an analysis of alternatives report on the program, which Probst expected to be completed in February, although its results may not be released to the public.
An amendment in the 2011 Homeland Security authorization bill required that strict criteria be met before any new biodetection system goes forward. The amendment also provided guidelines for improving the functionality of the currently deployed system.
PositiveID received $30 million in funding from DHS’ science and technology directorate to develop the system. It was a tough technological challenge, and it took the company six years to reach its goal, Probst said.
“It is a whole lab in a box, essentially,” he said.
There are two potentially dangerous classifications of bio-hazards: pathogens and toxins. They require different processes.
Pathogens are living organisms, and toxins are nonliving. M-BAND has modules that can be separately swapped out or maintained for each of them.
Among the toughest problems the company had to solve was how to collect and purify the pathogen samples without damaging them, he said.
The device collects everything up to 10 microns in size. M-BAND was tested for one year in the Boston subway, which was rife with brake dust from the trains, he said.
“We are able to rinse all of that away and hold onto the organisms that we are looking for,” he said.
The pathogens are then grown inside the module to where there is a large enough sample of their nucleic acid, better known as RNA or DNA. The genetic sequence is automatically examined to see if it is one of the dangerous pathogens such as anthrax, plague or even non-weaponized influenza.
The box can currently detect six different organisms comprising 16 unique signatures. A technician may want to look at two to four different signatures to ensure that it is positively what he is looking for. Anthrax, for example, has both dangerous and harmless strains. The device should be able to determine if there is truly cause for alarm, he said.
M-BAND has the capacity to detect up to 10 to 15 different pathogens, if required. It also has the ability to detect three different toxins such as ricin, with the room to expand to four, if needed, Probst said.
The M-BAND works on six-hour cycles, he said.
“With results every three hours, you can take action … for affected areas, even before people start showing symptoms,” he said.
The re-agents that test for the presence of bio-hazards must be replaced every 30 days. Modules that are broken and need to be serviced at a depot can be swapped out in 15 minutes, he said.
The cost savings come in the greatly reduced logistical tail, he said. The machines can be programmed to run for only a few hours a day if that is all that is required, he added.
PositiveID is awaiting what comes out of the analysis of alternatives to see how DHS will proceed. Documents show that the department is interested in purchasing up to 2,500 units, he said.
Meanwhile, PositiveID has partnered with The Boeing Co. to market M-BAND domestically. A potential customer is the Defense Department’s joint program executive office for chemical and biological defense, Probst said. It has also inserted some of the technology into a handheld device, the Firefly, for the civilian healthcare market.
Credit: M-BAND (PositiveID photo)