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IntegenX Starts Early-Access Program for DNA ID System to Prep for 2012 Launch


By Ben Butkus

IntegenX this week announced an early-access program for its automated sample-to-answer DNA identification system and named UK-based Key Forensics Services as the first partner under the program as it gears up to commercially launch the platform early next year.

In addition, IntegenX noted this week that its system, called the RapidHit 200, recently underwent successful operational testing at a two-week emerging technology event held by the US Department of Defense, demonstrating its potential as a tool for conducting DNA-based identification on the battlefield.

Pleasanton, Calif.-based IntegenX develops and markets instruments, reagents, and systems for improving and automating DNA and RNA sample prep. The company's core technology, called microscale on-chip valves, or MOVe, is used to automate and miniaturize complex chemistries through pneumatics, enabling the company to integrate various laboratory workflows into complete sample-to-answer systems.

One of these systems is the RapidHit 200, a self-contained, automated system for human DNA identification in the field. The system delivers results from buccal swabs, blood, objects, and other human tissue samples in less than two hours, instead of the typical 12 to 15 hours it would take in a laboratory, according to the company.

The system can simultaneously process up to eight samples, including controls, with short tandem repeat analysis. The platform integrates all sample-handling steps through cell lysis, DNA extraction, PCR amplification, capillary electrophoresis-based separation, and laser-induced fluorescence detection.

In February, IntegenX inked a deal with Caliper Life Sciences to gain access to its microfluidics patent portfolio; and with SoftGenetics to gain access to its forensics data-analysis software. Both deals were intended to build out the capabilities and accelerate commercialization of the RapidHit 200.

RapidHit 200 was previously known as the Apollo 200, and then the Apollo 200 RapidHit, until the company decided to shorten the name to the RapidHit 200 based on customer feedback.

"The commercial name was the result of feedback from our commercial and DoD customers that RapidHit was more descriptive, easier to remember, and easier to distinguish from other kinds of products," Howard Goldstein, executive vice president of commercial affairs at IntegenX, wrote in an e-mail to PCR Insider this week.

Goldstein noted that the product was developed wholly within IntegenX with primary research funding from government grants and contracts and with commercial development funds from the company's shareholders.

Under its early-access program announced this week, IntegenX will provide global partners with advance product access and training. Early-access customers will also receive pre-production prototypes of the RapidHit 200, disposable reagents and cartridges, and application priority in the US and abroad, the company said.

IntegenX said that its first partner, Key Forensics Services, will optimize and use the RapidHit 200 for commercial forensic services in the UK. Key objectives of the partnership include validating the RapidHit 200 and introducing fast human identification services to police forces in England and Wales, the company said.

"KFS believes that the RapidHit 200 system will revolutionize the provision of DNA profiles, enabling samples to be profiled within two hours at police [stations] within the UK," Paul Hackett, KFS' managing director, said in a statement.

"The device has the potential to transform the way KFS conducts DNA analysis by delivering unprecedented improvements in turnaround times, producing DNA testing away from the laboratory such as at the scene of the crime, and reducing overall forensic supply chain costs," Hackett added.

IntegenX also said this week that it has received some initial validation of the RapidHit 200 system as part of a two-week DoD event in which engineers and technicians from several companies participated in tactical scenarios designed to evaluate functional integration of emerging technologies.

Goldstein said that he could not provide additional details on the event or its other participants. However, IntegenX said that during the testing, the RapidHit 200 "repeatedly delivered correct identifications in less than two hours during simulated operational scenarios" conducted by the DoD. IntegenX said it was the only company at the event to demonstrate rapid DNA-based human identification.

"Profiles were obtained from DNA isolated from both cheek swabs and objects used by participants, and familial relationships were correctly inferred from blinded tissue samples that were several years old," Goldstein said, adding that the platform demonstrated a 100 percent profile generation success rate.

IntegenX said that it is now accepting sales orders for the RapidHit 200, and that it will begin making the system available to early-access customers at the end of this year, with a full commercial launch planned for early 2012.

Other platforms from IntegenX featuring the MOVe technology include the Apollo 100, which automates sample prep for Sanger sequencing; and the Apollo 324 library-preparation system for next-gen sequencing.

IntegenX also said in October that it had been awarded a contract from the DoD worth up to $14.8 million to develop an integrated, sample-to-sequence system to rapidly detect and identify genetically engineered, medically relevant, and emerging pathogens from environmental samples (PCR Insider, 10/14/10).

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.