GenomeWeb Breaking News: PositiveIDs (PSID) ExcitePCR Subsidiary Aims
to Launch Two Versions of POC MDx Platform Over Next Two Years
GenomeWeb.com Releases Breaking News on ExcitePCR Technology
That Detects Pathogens In Real-Time Results Preventing Infectious
Diseases From Rapidly Spreading.
NEW YORK 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 CMO 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 Positive ID 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.
About PositiveID Corporation
PositiveID Corporation is a holding company focused on life
sciences, diagnostics, mobile laboratories, and medical devices.
PositiveIDs ExcitePCR subsidiary is developing the FireflyDX family
of pathogen detection systems, portable devices offering rapid
sample-to-result detection in less than 30 minutes using real-time
polymerase chain reaction chemistry. PositiveIDs E-N-G Mobile
Systems subsidiary is a leader in the mobile technology vehicle
market, with a focus on the laboratory market and homeland
security. PositiveIDs Thermomedics subsidiary markets the
FDA-cleared Caregiver non-contact thermometer for clinical use. For
more information on PositiveID, please visit
http://www.psidcorp.com, or connect with PositiveID on Twitter,
Facebook or LinkedIn.
On August 24, 2017, PositiveID Corporation and its wholly-owned
subsidiary PositiveID Diagnostics, Inc. (collectively, the Seller),
entered into an Asset Purchase Agreement (APA) with ExcitePCR
Corporation. Pursuant to the APA, at closing, the Seller will sell
and deliver to ExcitePCR all assets used in connection with the
operation of the FireflyDX technology. For more information on the
APA, please read PositiveIDs Form 8-K filed on August 28, 2017,
which can be found
here.
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