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Life Tech to Distribute LGC Forensic DNA Analysis System as Firms Eye Field-Based Testing Products

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Life Technologies said this week that it has become the exclusive worldwide distributor for LGC Forensics' recently launched ParaDNA platform, a portable DNA testing system designed to determine the quality of human DNA more quickly and efficiently than existing methods.

For Life Tech, the agreement helps address a gap in its overall forensics product portfolio and move one step closer to providing a "total solution" for DNA-based testing to law enforcement officials and crime labs, the company said. Meantime, for LGC, the deal allows it to take advantage of Life Tech's sizable and well-established distribution network in the forensics space in order to sell more ParaDNA systems in Europe and the US, and eventually worldwide.

In addition, officials from both Life Tech and LGC said that ParaDNA is a preview of sorts of fully integrated sample-to-answer DNA forensics testing systems currently under development at each company.

According to the companies, ParaDNA is an easy-to-use, high-speed DNA testing system that allows rapid onsite identification of samples suitable to submit for more detailed analyses, such as STR analyses, in more centralized laboratories. The system is expected to help reduce laboratory backlogs and turnaround times for processing so investigators can focus their attention on samples most likely to generate a genetic profile.

"We're trying to determine whether there is human DNA present in a sample collected in a crime scene," Mark Dearden, business unit director for ParaDNA at LGC Forensics, told PCR Insider this week. "There are a lot of samples collected around a crime scene that don't generate useful information when they go into the lab for analysis. And so the crucial thing we’re trying to do is speed up that decision-making process on whether that sample is going to be useful and should it be processed in the lab."

Nadia Altomare, head of the human identification business for Life Tech, told PCR Insider that ParaDNA "allows us to get more probative and investigative information upfront, to ensure that the downstream part of the workflow is as productive and cost-effective and efficient as possible."

More specifically, prior to conducting a full DNA analysis, ParaDNA can quickly and easily reveal three pieces of information: which samples contain human DNA; which are most likely to provide a DNA result or a useful profile; and the gender of the DNA contributor, Altomare said.

"It's going to inform the submission policy and put more of an objective process in place," she said. "Every lab has its own submission policy that they agree to with local law enforcement … and you might have a lab whose policy is five pieces of evidence from a particular crime scene. This allows you to ensure that the best five pieces of evidence are submitted for that case to that crime lab."

The underlying technology that enables ParaDNA is PCR in combination with LGC's proprietary HyBeacons probes. Originally developed for genetic screening, HyBeacons are sequence-specific hybridization probes containing two fluorophores per probe that create a robust fluorescent signal. HyBeacons are not hydrolyzed during PCR amplification, and positive confirmation of the amplicon is available by way of high-definition melt curve analysis.

"We run a PCR, and then we assess the melt curves, which basically are evident because of the probe technology," Dearden said.

In 2009, LGC licensed the HyBeacons technology to Evogen along with sub-licensing rights for specific markets. Last month, Evogen said that it had granted rights to Focus Diagnostics, a subsidiary of Quest Diagnostics, to incorporate HyBeacons probes into molecular diagnostics products and services (PCR Insider, 3/14/2013).

Deardon said this week that LGC is currently the only company using HyBeacons for forensic DNA testing applications.

He added that LGC only recently launched ParaDNA after conducting pilot testing of the platform with various UK law enforcement agencies, meaning that the distribution agreement with Life Tech also essentially marks the full commercial availability of the product.

For Life Tech, ParaDNA brings the company — already a dominant player in the forensic DNA testing market — one step closer to providing what Altomare called a "total solution."

"It really gets us into a new customer segment — law enforcement — in more specific and tangible ways," Altomare said. "In the case of ParaDNA, we are looking to bridge the communication — what we see as gaps and unmet needs — between law enforcement and the crime lab DNA analysts."

Life Tech's products for forensic and human identification applications include the 3500 Series Genetic Analyzer and 7500 Real-Time PCR system for human identification; the AutoMate Express forensic DNA extraction system; AmpFℓSTR PCR human identification kits; Quantifiler DNA quantification kits; PrepFiler forensic DNA extraction kits; and GeneMapper ID software. In September, the company launched the next generation of its STR analysis kits for human identification and forensic applications, the GlobalFiler and GlobalFiler Express (PCR Insider, 9/20/2012).

"We have a variety of instruments for detection," Altomare said. "The intent is to continue the entire workflow, and there are several parts to that, of course – you would extract DNA, quantify it, amplify it, and go to the detection and analysis after. That entire workflow would stay intact. This is just … ensuring that you put the best evidence samples through that workflow."

Another current gap in Life Tech's forensic testing portfolio is a rapid, potentially field-based, sample-to-answer DNA testing system along the lines of those recently commercialized by IntegenX and by partners NetBio and GE Healthcare (PCR Insider, 10/4/2012), as well as a system being developed by ZyGem (PCR Insider, 12/15/2011).

But Life Tech may soon address that gap.

"Clearly [ParaDNA] is a rapid solution, and certainly within the industry there is a paradigm change as it relates to having a sample-to-answer solution in a decentralized way through law enforcement, and this is one of many products that we look to launch in the marketplace over time … where a profile can be produced in the field," Altomare said.

She added that Life Tech is "working on several solutions" for this purpose. "On the market right now there are solutions for more rapid and portable platforms, but for reference samples only. And more importantly, from a market-adoption standpoint, the costs are pretty high. It costs about $40 to process a sample in the crime lab, and the [sample-to-answer] solutions in the marketplace today are about $350 a sample. And the instruments are in the $300,000 range. We're looking to produce a solution from a reference and a casework perspective that's low-cost, and very quick."

LGC Forensics is also developing more portable products for DNA testing. First, the company is developing a more condensed version of the ParaDNA platform.

That platform, he said, "is effectively taking the existing unit, which is powered with a separate laptop, and condensing that down with an on-board PC and battery power. It is the same sort of size that meets [US Transportation Security Administration] carry-on baggage standards, about 17 kilograms in weight. It's a compact platform that could be transported to the scene of a crime or a disaster and used there to provide information and intelligence … about the quality of the samples they're collecting at those scenes for subsequent confirmation in the lab."

In addition, according to the LGC Forensics website, it is working on "a portable, battery-operated system … for use at crime scenes, enabling samples to be processed on the spot. This field instrument will deliver DNA profiles that can be speculatively searched against a DNA database in about an hour."

Further detailing this effort, Deardon said that current sample-to-answer systems "are primarily aimed at what we would call single … reference samples. They will operate in a police station or custody suite. Our system is effectively going to be for assessment of crime scene samples."

He added that this testing platform "has been tested in a number of different circumstances at prototype level so far, and we anticipate that it will be available in the summer, towards beginning of autumn."

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