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ExcitePCR Aims to Launch Two Versions of POC MDx Platform Over Next Two Years


NEW YORK (GenomeWeb) – ExcitePCR has been developing a real-time, point-of-care technology called FireflyDX that diagnoses diseases using a wide variety of sample types and requires as little as 10 minutes for sample preparation time.

The company is currently developing two devices based on the technology: the FireflyDX-Portable, which fits in a backpack and is planned for commercial release in summer 2018; and the FireflyDX-Handheld, which is planned for a commercial launch in 2019, ExcitePCR CMSO David Politis said. He added that the technology will detect pathogens in situations where real-time results can prevent infectious diseases from rapidly spreading.

Tracing its origin back to 2004, ExcitePCR originally began as Microfluidic Systems, one of seven companies awarded contracts by the US Department of Homeland Security (DHS) to develop a solution to automatically detect airborne pathogens. The firm received over $35 million in DHS funding before PositiveID acquired Microfluidic Systems in 2011 with the intent of developing portable real-time biohazard detection systems. Then, earlier this year PositiveID formed ExcitePCR as a subsidiary to further develop and commercialize the Firefly technology.

Politis explained that compared to some other POC devices, which can weigh 50 to 70 lbs and require the use of a separate personal computing device, the Firefly device will weigh less than 10 lbs and won't require an external computer to perform its functions. A RFID chip in the disposable cartridge notifies the device which assays it contains, allowing the device's firmware to know which sample preparation and thermal cycling protocols it needs to perform.

The company's technology has the ability to "use any sample to test for the presence of a bio-hazard or pathogen – a stool sample, urine, blood, serum sputum, swabs, it really doesn't matter," Politis said. "As long as you put it in a testable format, we can test it."

Researchers collect the sample, insert it into the company's cartridge, seal it off, insert the cartridge into the device, and press one button, finishing their responsibilities. The Firefly device then performs the rest of the operation, including the sample preparation and PCR analysis.

"Sample prep is still one of the biggest issues as far as time, [as] it's just a time sink," said Politis. "If you can go and swab someone's throat ... do a blood [draw], drop it in a cartridge … push it closed and press a button, then there really is no sample prep, sample prep goes away since it's done internally," he added. "To our understanding, no one is doing on-board sample preparation within [a point-of-care] system, which allows us to go from sample capture to test results within 30 minutes or less."

The company intends to have cartridges that work with all of its devices and that are easily interchangeable from device to device. The company's first cartridges will allow users the ability to simultaneously detect four different pathogens while maintaining the high levels of accuracy delivered by laboratory PCR solutions, according to the firm, and the devices will be able to detect targets in less than half an hour.  

ExcitePCR's Firefly devices are currently in the late-alpha, early-beta stage. While it has not set the final price for Firefly, Politis believes that the company will market the devices at around $30,000. According to Politis, the company aims to keep the price for its individual cartridges relatively cheap, or "at least on a competitive basis with the rest of the industry."  

Though Politis said that ExcitePCR is unable to disclose most of its early adopters at this time, he revealed that the firm has partnered with Maryland-based firm GenArraytion to develop assays on its FireflyDX prototype for the past two years. GenArraytion CEO and Cofounder Paul Schaudies is also a member of ExcitePCR's Advisory Board.   

GenArraytion's Multiflex assays offer a broad range of real-time PCR assays for four different pathogens: mosquito-borne pathogens, tick-borne pathogens, hospital-associated pathogens, and biothreat agents. With over 20 targets in each panel, GenArraytion's technology will allow FireflyDX users to customize assays to suit their needs.

"We think [FireflyDX] is something the [sample-to-answer] market really needs, as [it's] easy to use, lightweight, and low power," GenArraytion COO Doreen Robinson said.

In initial trials using FireflyDX benchtop prototype technology, GenArraytion's Multiflex assays detected trace amounts of diseases including the Zika virus, Ebolavirus, Yersinia pestis, Plasmodium vivax, Burkholderia mallei, and Francisella tularensis in 30 minutes or less.

"The value we think we can bring to the collaboration is when [the devices] launch in very short order ... they have a test menu of upwards of 100 infectious disease tests right off the bat,"  Robinson said.  

While ExcitePCR is working with GenArraytion to produce assays for its device, Politis emphasized that the company's technology is agnostic from an assay standpoint.

"We currently have a partnership in place with GenArraytion … but the reality is that if we have a client who likes to use assays from another provider, we don't care… we want to make sure it's easy for them," he added.  

Politis foresees the FireflyDX technology being used in a variety of targeted markets including human infectious diseases and noninfectious diseases, and in hospitals and other point of care settings.

According to Politis, the FireflyDX's simple design allows it to be used in the field by non-professionals and non-technicians. The device's 15- to 16-hour battery life allows first responders to detect biothreat agents, from crowded metropolitan centers to rural areas, without electricity.

ExcitePCR also envisions participation in the agricultural market where FireflyDX could potentially improve food and animal safety through detection of diseased animals and tainted produce, Politis said.