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PositiveID Developing Handheld Version of Cassette-based MDx Platform

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Pursuing what it sees as a burgeoning interest from investors and potential partners in increasingly smaller molecular diagnostic platforms, PositiveID has begun developing a battery-operated, handheld version of Dragonfly, its benchtop, cassette-based molecular testing system, the company said this week.

PositiveID is betting that the field-deployable system, dubbed Firefly Dx, will attract development partners in applied markets, such as biodefense, biodetection, and environmental monitoring, and that this interest will pave the road for clinical applications such as infectious disease testing in resource-limited parts of the world.

The development activities around Dragonfly and Firefly Dx take place mainly through PositiveID subsidiary MicroFluidic Systems, which PositiveID acquired in 2012 in a deal worth up to $8.2 million (PCR Insider, 5/19/2011). PositiveID, based in Delray Beach, Fla., had specialized in security identification tools but dabbled in the healthcare arena, offering products such as implantable RFID microchips for patient identification and an implantable glucose monitor for diabetics.

MFS, meantime, was founded in 2001 by Allen Northrup, who previously co-founded Cepheid and was its chief technical officer and vice president of research. The company originally used funding from the US Department of Homeland Security to develop a product called the Microfluidics-based Bioagent Autonomous Networked Detector, or M-BAND, an airborne biothreat-detection system about the size of a large refrigerator.

MFS then developed Dragonfly, a benchtop version of M-BAND that processes test cartridges pre-loaded with specific real-time PCR-based molecular diagnostic assays. When PositiveID acquired MFS, it took over development of the Dragonfly system, integrating its own technologies such as the RFID chips for easy assay identification and tracking.

In March 2012, MFS won a key patent covering its microfluidic-based sample processing cartridge, and company officials told PCR Insider that the firm was aiming to commercialize Dragonfly within two years as a push-button, sample-to-answer, CLIA-waived device for applied markets and eventually clinical diagnostics (PCR Insider, 3/29/2013).

However, this week, Lyle Probst, president of Positive ID's MFS subsidiary, told PCR Insider that for the time being the company was putting Dragonfly's development on the backburner and focusing its efforts on the new handheld version, Firefly Dx.

"We've continued developing [Dragonfly], but as we were looking at it, and looking at the needs of the market, we realized we should focus on taking this down even smaller into the handheld device with all the same capabilities," Probst said. "We started with a design exercise [to explore whether] we could make all this fit into something that's hand-held … and make it work on a battery and be field-deployable. And the answer was 'yes.' So we've formally made it an internal R&D project, whereas over the last two or three months it was a concept."

Probst added that PositiveID was primarily motivated by what it sees as an industry trend toward smaller, easier-to-use molecular diagnostic platforms.

"In talking with government parties [and] potential commercial partners about development of Dragonfly … we've found that … given the economic state that we're in, there is not a lot of funding for the benchtop-type instruments, and there is much more interest in something that is handheld and portable that you can take out in the field and into resource-limited areas," Probst said.

Firefly Dx will retain much of the same functionality as Dragonfly, and in fact, both systems will be able to run the same microfluidic test cartridges. However, Firefly Dx will be handheld and operated by a removable and rechargeable battery pack.

Firefly Dx also features a "new type of PCR module" that is different than the company used in past instrument, Probst said. He declined to describe this PCR module in detail, as the company is in the process of patenting it, but he noted that "by shrinking that down we saved a lot of room and also reduced the power consumption. One of the things with running a handheld device is that you don't have a lot of power available when running off a battery pack." The company anticipates that Firefly Dx, like Dragonfly, will run TaqMan-based real-time PCR assays.

Probst said that Firefly Dx should be able to run around 10 or a dozen samples before being recharged. The company believes that the system will be able to provide test results from raw sample in 15 to 30 minutes and is designing it to be compatible with a variety of sample types, including whole blood, buccal and nasopharyngeal swabs, urine, and environmental field samples.

"There's just one button to run it," he said. "You load the sample into the cartridge, and all the functionality to process the sample is contained in the cartridge. You load that into the handheld Firefly unit … and the RFID tag is programmed [with] assay information. The system reads that chip, knows the protocol to run it, and all the user does is press start. So it doesn't require a highly trained person, and it can go in resource-limited areas."

Finally, to facilitate data transfer from the field, the company is installing Bluetooth functionality so Firefly Dx can be coupled with a smartphone or tablet, which can then connect with a central lab or the cloud to disseminate testing results.

Probst said the company is seeing initial interest in the new system from many of the same applied markets that it was targeting with Dragonfly — i.e. biodefense and biodetection — but also from new markets such as environmental testing.

And, it is easy for the company to conceptually make the leap to field-based clinical diagnostics, but harder to actually pursue such an application, he said.

"There is a lot happening in that field, and molecular diagnostics is a long path to go down," Probst said. "But we did design the instrument with a CLIA waiver [and 510(k) approval] in mind so that we could help it go through the [US Food and Drug Administration] process a little more quickly.

One specific clinical application area the company sees is molecular testing of influenza, particularly in resource-limited areas where outbreaks of new strains of the virus continue to occur. "This could be used to go out in the field, remote areas, where you can't really take a big instrument."

Probst said that PositiveID hopes to begin field-based testing of Dragonfly Dx in 2014, "probably by the second quarter." Before that, though, the company hopes to have an operational prototype to demonstrate to potential partners before the end of this year.

In April, PositiveID, which trades on the over-the-counter bulletin board, said that its board approved a 1-for-25 reverse stock split, reducing the number of PositiveID shares to about 15 million. The move was intended to enhance the appeal of its common stock to the financial community in the hopes of raising additional funds to develop its molecular diagnostic technologies.

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