PositiveID’s handheld device makes rapid biological testing user-friendly

PositiveID's Firefly DX device | PositiveID Corp.

PositiveID Corp. is developing a device that’s poised to revolutionize the growing sector within medical equipment known as molecular diagnostics and testing equipment, a multi-billion-dollar market focused on real-time or quantitative PCR (polymerase chain reaction) pathogen detection.

Now in development, PositiveID’s Firefly Dx is designed to provide any emergency responder with real-time, accurate diagnostic results in a handheld device that will be able to pump out the needed information within minutes, rather than sending off samples to a lab and waiting 24-48 hours for results.

“This device doesn’t require a highly specialized technician,” Lyle Probst, president of PositiveID, told BioPrepWatch. “You don’t have to know anything except how to run the device so it’s very user-friendly.”

The Delray Beach, Fla.-based biological detection systems developer plans to provide rapid biological testing to America’s homeland defense industry, enabling it to be better able to fight drug-resistant superbugs, disease outbreaks, and threats from biological weapons.

“PositiveID’s technology in this space is potentially game-changing,” said Parker Mitchell of Regal Consulting LLC. “The ability to use the right drug for the right disease is often the difference between life and death.

“In addition, with endemics like SARS or Ebola,” Mitchell said, “detection can prevent the disease from spreading on a much larger scale. It allows organizations like the National Institutes of Health to more quickly make decisions and respond to threats.”

Specifically, the company’s Firefly Dx – being developed at PositiveID’s Pleasanton, Calif., lab -- is a handheald device having two parts, Probst said -- the portion that runs the test and the disposable cartridge, “which is key to how the system works.”

“The cartridge has a pack that’s preprogrammed for whatever test you’re looking for; each cartridge is specific to the test being run,” he said. “The processing steps are in the cartridge. You put the sample in, you get the results out.”

For example, once the cartridge and the sample are inserted into the handheld device, Probst said that results are available within 15-20 minutes, depending on what test is being run. “A spore like anthrax could take a little longer,” he said.

Funding for development of Firefly Dx is through the U.S. Department of Homeland Security. In early May, PositiveID announced that it’s able to test for E. coli using the PCR chip in the Firefly Dx handheld prototype, which detected the pathogen in less than 20 minutes. And then in late May, the company’s system successfully detected the influenza Type A virus. The Firefly Dx has the capability to screen for and detect multiple strains of the influenza virus simultaneously with a single test. Other strains currently being tested include Influenza B, H1 and H3 strains.

In addition to Firefly Dx being used by first-line responders, the device will be useful to test for diseases in well water supplies; at farms and food processing facilities; and in hospitals, doctor’s offices and clinics. And Probst said the company also plans to make Firefly Dx available to the U.S. military.

“We want to provide a next-generation product that’s cheaper, easier to use, and more effective,” Probst said.

When will Firefly Dx be commercially available? “Hard to say,” Probst said.”It really depends on the application and the market.”

Organizations in this story

National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892

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