BD Diagnostics (Baltimore) reported that the FDA has granted clearance for a robotic system called the BD Viper System that can essentially mimic the laboratory movements of a lab technologist for in vitro infectious disease molecular diagnostic testing.

Its parent company, BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey), said the BD Viper System is an approach to laboratory automation using an industrial class of robotics known as Selective Compliance Assembly Robot Arm (SCARA). That classification indicates that the robot is multi-jointed, similar to the human arm, the company said.

Ric Hughen, director of market for molecular diagnostics for BD, told Diagnostics & Imaging Week that the system "attacks lab automation from a pick-and-place standpoint similar to what a technologist does with a hand pipetter."

He added: "They pick something up with a pipetter and they move it to another location and dispense it, and you've not been able to do that historically, because the equipment was either inaccurate or unreliable or both."

The reason such "1950s-type technology" was unreliable was because it relied on pumps, reagent tubing and syringes — all components that are eliminated with the Viper system.

The BD Viper System automates previously manual and semi-automated steps of the BD ProbeTec System, first marketed in 1998, which is the only commercially available real-time DNA amplification assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Viper also is approved for Legionella, another pathogen.

Currently, about 1,100 laboratories worldwide use this system, and within the U.S. "in excess of 700" use the system, Hughen said.

"Incubations, amplification and detection all occur on the BD Viper System, with repetitive pipetting labor delegated to the robot," the company said.

The Viper System uses the "proven chemistry" of Strand Displacement Amplification (SDA), making SDA a "leading" technology in the area of amplified testing for Chlamydia and gonorrhea.

"The isothermal, real-time amplification and detection offered by SDA has greatly simplified complex molecular testing, making this technology more accessible to clinical laboratories," the company said.

However, the Viper system will only be marketed to the top 200 labs, which are considered medium- to high-volume labs, of the 1,100 that currently use the ProbeTec System.

"Viper is a medium-high to high processor, and it would be inappropriate for some of those in the low- and low mid-volume [capacity]," Hughen said.

He described a high-volume lab as one that completes 50,000 to 70,000 tests per year, whereas a medium-volume lab might conduct 25,000 to 50,000 tests annually.

The Viper System features one core robot that has approximately a "280-degree circular pipetting ability," Hughen said.

"When we originally were designing this unknown piece of equipment years ago, we actually took the existing generation of pipetters — Hamilton pipetters, Tecan pipetters — and some of the equipment out of robotics shops in Japan," he said.

What the company found was that if you bolt a ballpoint pen to such a robotic device and program it to pipette to the same spot over and over for a month, there is "huge drift."

"If you do that same experiment with a SCARA robot, you get that one spot and it doesn't drift for months on end," he said. "It's just absolutely bulletproof."

BD also said that such a robot, which allows high throughput, also helps address the critical shortage of technologists in laboratories. By minimizing hands-on time, the technologist can take advantage of load-and-go workflow, letting the robot do the processing work.

Robin Felder, PhD, director of the Medical Automation Research Center at the University of Virginia (Charlottesville), where the focus is the study of robotics, agreed that the Viper System, which he has seen, is unprecedented.

"It is unprecedented in an elegant combination of a good molecular diagnostics chemistry with a high-precision robot requiring minimal maintenance," he told D&IW.

The minimal maintenance part is key, because Felder said the reason most robotics systems fail is that they are not as "robust." He said the Viper System, in his opinion, "sets a new standard for robustness in molecular diagnostics automation and a standard in versatility, allowing a wide range of tests to be put on a single platform.

However, Felder also said he doesn't see Viper as the "penultimate diagnostics automation system," because it is just "far too large."

He said, "We are in a flux state now in the molecular diagnostics arena, and this is an excellent intermediate technology that will have a fairly long lifetime before the next generation comes along."

There are other examples of robust robotics systems, such as a system by Protedyne (Windsor, Connecticut). However, it does not have the molecular diagnostics component, Felder said. Instead, he said, Protedyne will program a particular company's diagnostic method onto its robot.

As for automation in the laboratory, Felder said the move toward robotics in that arena is "inevitable."

"We have a crisis in having an insufficient number of laboratory technologists moving into the field and an aging current medical technologist pool soon to be retiring," he said. "Automation is the only way to fill that gap in. And we have an increasing need for productivity in laboratories particularly because of the onset of molecular diagnostic testing."