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IntegenX Launches Next-Generation Rapid Forensic DNA Platform

The RapidHit ID instrument.

NEW YORK (GenomeWeb) — IntegenX, a manufacturer of short tandem repeat PCR-based rapid DNA profiling platforms, has launched a next-generation instrument.

Called RapidHit ID, the platform processes a single buccal swab in about 70 minutes with little hands on time and no laboratory expertise required.

The new instrument is ultimately designed to enable decentralized DNA testing of suspects in places like booking stations and police precincts, and the cost of running samples on it will be about one quarter that of the firm's first-generation platform, the RapidHit System.

IntegenX debuted the new platform at the International Society for Forensic Genetics annual meeting in Krakow, Poland this week.

The company also presented a small study of the platform, performed by Bruce Budowle at the University of North Texas, who the firm noted is one of the top scientists in the field of forensic genomics.

That validation concluded that RapidHit ID is "able to genotype reference buccal swabs in 70 minutes in a fashion that is comparable to standard benchtop methods," using either of two popular Thermo Fisher Scientific chemistries, GlobalFiler Express or the NGM kit.

RapidHit ID is "one quarter the size of our first-generation instrument and the cartridge is dramatically simplified," IntegenX CEO Robert Schueren told GenomeWeb from the ISFG meeting.

"Each time you run the unit you run a single-use cartridge that has just the STR [chemistry] and enzymes on it … you don't need [to add] the buffers, the gel, and the lysing reagent each time," he explained.

Instead, those reaction components are housed in a larger disposable element that slides into the instrument, which Schueren likened to a "printer-toner cartridge." This cartridge contains enough reagents for 250 individual analyses and also holds waste.

The larger disposable cartridge also contains the capillary board, the air filter for the instrument, and the o-rings, "so every time the user changes that out, they essentially do all the maintenance for the instrument," Schueren said.

Schueren noted that to the best of his knowledge, the system may be the first commercial nucleic acid amplification platform with a disposable capillary electrophoresis component.

"We've even taken some common Sanger sequencing reagents and samples, put them through that system, and gotten very good data," he added.

Pleasanton, California-based IntegenX will continue to manufacture the original RapidHit system, which could suit users requiring the higher throughput of up to seven samples at a time.

Like all rapid DNA systems, RapidHit ID generates DNA profiles that are compatible with national DNA databases, such as the FBI's Combined DNA Index System, also known as CODIS.

Rapid DNA profiling may some day allow officers to match arrestee samples to FBI databases while they are still in the booking station, eliminating routine sample processing from the crime labs and freeing them to work on more complex evidentiary samples.

But uptake of this technology has been hindered by a number of factors.

The US Congress is currently weighing House Resolution 320, an amendment to the DNA Act of 1994 to permit DNA testing to be done in "booking stations, jails, prisons, [and] detention centers," in addition to the laboratory settings that are currently allowed.

In the meantime, use of rapid DNA technology is limited by the wording of the law, requiring tests to be run in certified forensics laboratories.

Interestingly, the list of co-sponsors of H.R. 320 has now grown to nine congresspeople and it has bipartisan support.

Cost had also been considered a factor in uptake of rapid DNA technologies, as Peter Vallone, a researcher at the National Institute of Standards and Technology, recently told GenomeWeb.

Schueren said that the new platform will reduce costs in two ways.

The capital cost of the instrument itself is substantially lower — about $149,000 compared to around $250,000 for the first-generation instrument.

"At launch, we are comfortable with the design and the economics behind the design that for commitments to volume we can be even more aggressive," Schueren noted.

The first-generation instrument also requires processing a number of samples simultaneously to be most cost-effective, so users have to balance speed with per-sample costs. The cartridge was previously quoted at $1,000 to $1,500 to run five to seven samples.

The RapidHit ID sample cartridge, meanwhile, is much simpler than the first-generation cartridge — it is a single piece of injection-molded plastic — and that enables a $150 per-test list price.

The consumable cartridges can be stored at room temperature for six months.

The new platform is about 25 cm wide, 55 cm tall, and 41 cm deep, and weighs about 20 kg. The firm also expanded the software on the instrument and the networking infrastructure.

The instrument has a large touch screen and is completely "user installable — plug it in, turn it on, [and] it's ready in 20 seconds," Schueren said. "There's on-screen videos to teach the person how to use it, there's an on-screen user manual, and there's live chat."

The instrument has three modes of access authentication: a camera on the top for face recognition, an integrated fingerprint reader, and a touchpad on the screen for password entry.

Once a password is entered, the camera is repurposed to read the barcode of the buccal swab, and after that it asks the user to put the swab in the single-use cartridge and insert the cartridge into the machine. In 70 minutes it will prompt the user to remove the cartridge, Schueren said.

"So, you never actually touch the instrument — there's no door to open — and the profiles themselves are transmitted to a centralized location and we don't allow the instrument to display any forensic results," he said.

If the profile matches one previously flagged, the centralized location can then send an alert.

IntegenX told GenomeWeb in June that it had placed more than 140 of the original RapidHit Systems, about two thirds of which were in international markets.

The firm announced last week that a first-generation system was recently used in the UK to reveal that a suspect arrested on a minor crime matched the DNA profile from a previously unsolved sexual assault case. That person was then prevented from being released on bail.

The result was obtained in a UK forensic laboratory on the second day after it had adopted the RapidHit technology, Schueren noted.

"I worked my whole career in diagnostics, primarily in oncology," he said, adding, "I had a strong feeling when I was asked to lead IntegenX that [the technology] provides a big social benefit and we can make a difference."