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Rapid DNA Forensic Testing Systems from IntegenX, NetBio/GE Healthcare Hit Market

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This article has been updated from a previous version to provide information regarding the name of ZyGem's DNA testing platform.

Rapid DNA testing may soon be the industry standard in law enforcement and human identification as a pair of commercial automated sample-to-answer DNA analysis systems launched this week.

In particular, the platforms — the RapidHIT 200 from IntegenX and the DNAscan from partners NetBio and GE Healthcare — are expected to help cash-strapped law-enforcement agencies more efficiently allocate their resources, as well as have a substantial impact on the way both violent crimes and non-violent crimes, such as property theft, are solved.

Both platforms made their commercial debut at the International Association of Chiefs of Police Conference and Law Enforcement Education and Technology Exposition, held in San Diego this week.

The products have more similarities than differences: both feature consumable cartridges that accept buccal swab samples and are subsequently inserted into a benchtop instrument that automates all aspects of cell lysis, DNA purification, amplification of short tandem repeat regions, and miniaturized capillary electrophoresis detection, and produces a DNA profile in around 90 minutes.

However, representatives from both companies this week highlighted subtle differences that they believe will distinguish their products.

RapidHIT 200

IntegenX, based in Pleasanton, Calif., will look to differentiate its platform based on its "reliability and robustness," president and CEO Stevan Jovanovich told PCR Insider.

"We've taken this out to a [US] Department of Defense exercise … and taken it to different places in the country and run it at shows," Jovanovich said. "And we've run about 3,000 samples over the last couple of months [internally]. We've done that early data collection, and know it performs … really well, and it's now in the hands of a number of users. These are primarily US government types, and they're doing their own evaluation of the system."

The RapidHIT 200 platform features bead-based cell lysis and DNA purification, followed by industry-standard amplification using a Promega Powerplex 16HS kit, which produces data that is compatible with CODIS in the US; or a Promega ESI kit for compatibility with the European STR analysis format. IntegenX in August 2011 inked a reagent supply agreement with Promega for the RapidHIT 200 (PCR Insider, 8/4/2011).

Each RapidHIT 200 assay uses two cartridges that accept buccal swabs: a sample cartridge and control cartridge. The control cartridge has three slots for a positive control, negative control, and allelic ladder, and one slot for a sample; while the sample cartridge features four slots for samples; thus, the platform can run up to five samples at once.

The cartridges contain all analysis reagents and need to be refrigerated, and have a shelf life of 60 days, although the company is currently developing a reformulation that will be stable at room temperature for six months or more, according to a spokesperson.

The cartridges are optimized for buccal swab samples, although Jovanovich said that the company has successfully run other samples types, such as blood, on the system. "We will at some point release cartridges that are tuned specifically for [other samples], but our standard buccal swab cartridge works pretty well," he said.

The cartridges are then placed into the RapidHIT 200 instrument, which performs amplification and features eight electrophoresis capillaries and a detection scheme that uses a laser and CCD camera.

"We made it so we don't have an air chamber; we actually put the capillaries on a printed circuit board where we control the heat on the board, rather than in an oven," Jovanovich said. "And our optics … can be shipped around the world without needing alignment. It's pretty normal technology, we just made it smaller and fit it into our instrument and then integrated it with the sample prep, which is all done in the cartridge."

Jovanovich noted that many IntegenX employees previously were involved with the development of the Amersham/GE Healthcare MegaBACE sequencer or the Applied Biosystems/Life Technologies PRISM 3700 Genetic Analyzers — know-how that the company applied in its miniaturized CE design. Along those lines, in May IntegenX acquired SV Corp, which was a subsidiary of GE Healthcare Biosciences, primarily in order to access SV Corp's intellectual property in the area of CE, separation, sample prep, and separation matrices (PCR Insider, 5/2/2012).

IntegenX also secured $40 million in Series C financing in December to accelerate RapidHIT 200's commercialization (PCR Insider, 12/15/2011); and the company launched the platform in Europe in August (PCR Insider, 8/23/2012).

One of the early users and first paying customers of the IntegenX platform is the Palm Bay, Fla., police department. Doug Muldoon, chief of the department, told PCR Insider this week that one of the hallmarks of the RapidHIT 200 is its simplicity.

"It's simple, that's the only way to put it," he said. "Basically things fit in one way. You can't put the cartridge in the wrong spot, it doesn't work, so you put the [sample] in, push the button and say go, and then you get your results. You couldn't make it any simpler unless it was all voice-activated."

Muldoon said that the platform is "going to be huge for us, and everybody in law enforcement," particularly because it will expedite the department's forensic DNA testing, which currently operates out of a central lab and can be backlogged due to a heavy amount of casework and limited resources.

"Our clearance rates have gone up tremendously, and it's taken care of the issues that drive our business," Muldoon said. "With finances as they are, the reality is we're having to do more with less in terms of manpower, and I think the fact that we work smarter versus harder is helping tremendously with the bottom line. Law enforcement is a business, and one of the things we have to look at is how we can … do things innovatively, using technology. It's exciting for us because we're on the cutting edge of law enforcement, and a lot of law enforcement agencies are kind of hesitant to put their heads out there and try something. This is one program where it's nice to know we've had input and guidance to make it work."

Jovanovich said that the RapidHIT 200 instrument costs about $245,000 in the US, while the two-cartridge package including all necessary assay reagents cost about $1,750.

DNAscan

NetBio, short for Network Biosystems, has been developing its platform for the past few years both for the molecular diagnostics field and the human identification space.

The company had been prepping its system for commercial launch this year, and at some point received a boost when it teamed with GE Healthcare to finalize development of the product (PCR Insider, 8/2/2012).

The deal also paired NetBio's instrument platform and analysis software with GE's global sales channels and existing forensics analysis products, including the EasiCollect sample collection product sold by its subsidiary Whatman.

It is this combination of expertise and capabilities that NetBio and GE Healthcare believe will set their product apart from others on the market, Mike Benevento, general manager of global services for GE Healthcare, told PCR Insider this week.

"A differentiator in an applied market like law enforcement [is] I think we have a great partnership between a company like NetBio with outstanding engineering and microfluidics, and a really great software platform that it developed … and GE, which has global reach and can provide sales, service, and technical support worldwide, and has a great reputation for quality," he said.

The DNAscan product also processes five samples at a time, although the scheme has a "slightly different design" than the IntegenX system, Benevento said.

"There is one cartridge, so it's very easy to use, and the system can be set up in roughly 15 minutes," he said. "It's a ruggedized design, so it's designed for use in a very active environment like a police station or booking office. And in less than an hour you can get someone trained to use the system – it's swab into the biochip, biochip into the unit, and then it's really walk away from there."

Another difference, he noted, is that the DNAscan biochip is stabilized such that it can be stored at room temperature. "So there is no need for refrigeration, which is a really big convenience factor," Benevento said.

Regarding the technological nuts and bolts, the system comprises three main components: the biochip, which accepts buccal swabs and blood samples; the instrument, which is a "little larger than a desktop printer," Benevento said; and the "Expert System" software for data interpretation.

"The biochip … locks into place, so it minimizes the possibility of cross contamination," Benevento said. "The swabs … are all RFID tagged … which maintains the chain of custody from the time you take the sample all the way through to the sample being processed and the data being analyzed. The entire process is contained in the biochip — the DNA purification/amplification, and the capillary electrophoresis all happen in the biochip, and it is a single-use cartridge … so no portion is reused, which really minimizes the chance of any cross contamination."

The DNAscan platform also uses industry-standard Promega STR analysis kits, and the company has an undisclosed sample preparation method that is enabled primarily by innovative microfluidics, Benevento added.

GE Healthcare began taking orders for the platform in the US this week, and expects to ship the first platforms to customers "late this year or early next year," Benevento said. The company plans to launch the platform internationally in 2013.

Richard Selden, NetBio's executive chairman and chief scientific officer, told PCR Insider in an email that DNAscan is currently "being tested by stakeholders in the Department of Defense, Department of Homeland Security, and Department of Justice;" and that five instruments are currently being tested in the field.

Benevento said that the instrument will cost about $250,000 and that GE is "targeting about a $300-per-sample cost" in terms of consumables, which would work out to about $1,500 per cartridge if each one can process up to five samples.

Expediting DNA Testing

Representatives from both companies lauded the launch of the platforms as ushering in a new era of rapid DNA testing in forensics and law enforcement.

"Rapid DNA technology is really going to dramatically expand how DNA can be used in practice by simplifying it and making it more accessible to police officers," Benevento said. "Right now capacity constraints in the crime lab really limit the use of DNA, which is the most reliable biometric for violent crimes. There is definitely an opportunity to improve public safety by decentralizing DNA testing."

Benevento also noted that due to capacity constraints in modern law enforcement forensics labs, "there are only so many samples that can be processed by the crime labs. Providing a platform where reference samples can be analyzed in a distributed fashion can ultimately expand the use of DNA to property crimes, which is the bulk of total crimes committed, and offer local law enforcement agencies the same benefits of DNA that they use only with violent crimes today."

Palm Bay Police's Muldoon echoed this idea, noting that "what's driving our business — and a lot of people don't realize that law enforcement is a business — is not murders and rapes … but property crimes, and things associated with that."

"Pretty much around the country … property crime issues are huge," he added. "This will allow us to attack those a lot [more quickly], because we can quickly identify suspects, and also rule out suspects, which is good, because at times we're focusing in on someone because of other circumstances, and we can clear them from the crimes we're looking at. It will help us expedite that."

IntegenX, NetBio, and GE Healthcare will compete primarily with each other for the time being, but should expect additional competition soon.

ZyGem and Lockheed Martin have been developing a rapid DNA forensic analysis product since at least 2011 (PCR Insider, 12/15/2011).

Based on infrared PCR technology developed in the laboratory of University of Virginia researcher and ZyGem CSO James Landers, the system will also feature proprietary lysis and DNA extraction technology and CE analysis.

In December, a company spokesperson said that ZyGem was targeting a full commercial launch of its system by the end of this year. However, the spokesperson said in an email this week that the company plans to commercially launch its system in 2013.

"ZyGem is currently completing the final development and validation of the system," the spokesperson said. "Features include a 90 minute sample-to-answer cycle, fully self-contained cartridges that eliminate risks of cross contamination, and a compact device size smaller than competitor units."

According to the spokesperson, Lockheed Martin will sell the platform under the name IntrepID S2A-90 primarily to customers in North America and the federal government; while co-marketing partner Morpho will sell the platform under the name Morpho FACT to police customers worldwide.

In addition, a group from the Center for Applied NanoBioscience and Medicine at the University of Arizona is developing a fully integrated, microfluidic forensic device for rapid multiplex PCR-based DNA analysis. However, it is currently seeking commercial partners to help move the platform to market after the group's previous primary collaborator, the UK Forensic Science Service, dissolved earlier this year (PCR Insider, 9/13/2012).

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