By Ben Butkus
Nascent medical diagnostics firm InstantLabs has developed a lightweight, portable, fully automated PCR system that it claims will reduce the cost of laboratory testing by as much as 15 percent and sample size and required reagents by 80 percent compared to currently marketed platforms.
InstantLabs, based in Washington, DC, plans to roll the first units off the assembly line by the end of March and place them at various gatekeeper organizations for the food safety industry globally in hopes of obtaining the necessary seals of approval to begin selling the system this summer, CEO Hans Kastensmith told PCR Insider this week.
The company is also currently negotiating with various core PCR patent holders such as Life Technologies and Roche to obtain freedom to operate, and hopes to submit its platform for regulatory approval for human diagnostic use by the end of this year, Kastensmith said.
The platform, called the Hunter Accelerated PCR system, is based on technology developed by Dongqing Li, a professor of engineering and Canada Research Chair in microfluidics and nanofluidics at the University of Waterloo in Canada.
Li, who specializes in lab-on-a-chip technologies, began developing the device in the late 1990s as a professor at the University of Toronto.
While employed as a professor of mechanical engineering at Vanderbilt University in the middle of the last decade, Li filed for a patent on his system, and last year was awarded US Patent No. 7,569,382, "Disposable reaction module and detection system."
By time the patent was awarded, Li had moved back to Canada to take his current position at Waterloo, and had exclusively licensed the rights to the patent to InstantLabs, which became aware of his work through a personal contact at the company, Li told PCR Insider this week.
"They found the technology interesting and started the company up around it," Li said. "They have since been developing new generations of a handheld device."
As described in the '382 patent, Li's original technology comprises a disposable glass/plastic chip with individual microliter-scale wells, a miniature heating and cooling module, and a multiplex fluorescence detection system. The patent also describes methods for performing PCR reactions using the system.
Li also developed microfluidics systems for sample preparation and manipulation; and software for analyzing the PCR reactions, according to InstantLabs' Kastensmith.
Li has published several papers describing specific diagnostic applications for the technology. The most recent, published online ahead of print earlier this month in the Journal of Biotechnology, describes how Li and colleagues at Vanderbilt used an early version of the system to detect unpurified methicillin-resistant Staphylococcus aureus DNA using minimal sample preparation.
"Vanderbilt's hospital wants to apply this technology to MRSA surveillance," Li said. "This paper showed the application of the system to MRSA detection."
Since InstantLabs licensed the technology, it has modified it somewhat to create a self-contained, portable, fully automated system for commercialization into specific markets, first and foremost the food safety industry.
"Li's technology contained multiple wells on the chip and uses electrokinetics and microfluidics for the actual process on the chip," Kastensmith said. "For Hunter, it's actually a static well, and we're doing everything with chemistry. There are more complex things we may get into, like forensics, where we'll need to use microfluidics … to move fluids from one well to another.
"The large part of his technology we adopted was to miniaturize the entire affair and make the software do the work," Kastensmith added. "Our focus right now is on micro systems, and on sample preparation. Whether we completely use microfluidics, or we use a combination of chemistry and microfluidics, will depend on the application."
The current "all-in-one" system that InstantLabs will market will use so-called multiple assay disposable cartridges, or MACs — disposable chips that can test six individual samples for a single analyte or six analytes from a single sample.
The Hunter PCR module has dimensions of about 16 by 12 by 10 inches and weighs around 15 pounds. It is capable of rapid heating and cooling with change rates of greater than 5º C per second; is controlled via touch screen; and is network-enabled so multiple modules can be viewed and controlled from a central computer workstation.
But the key feature, according to Kastensmith, is the minimal sample preparation required by Hunter users.
"A big key in the industry is not so much what or how you detect — you can use lots of different technologies for detection," he said. "It's being able to deal with raw sample being placed right on our chip and not having to go through the sample prep process. It's much simpler to take a very small sample of material, whether it's blood or a nasal swab; or slurry from a food production line; and to put that directly on the chip, put the chip in the machine, and press go. That's it."
InstantLabs is currently preparing provisional patent applications that will cover some additional engineering advances made at the company that allow inexpensive and compact thermal cycling to perform PCR reactions, Kastensmith said.
Then the company's next order of business is to place 25 of the Hunter units "into the food safety regulatory or 'seal of approval' bodies'" in the US, South America, India, and Southeast Asia, among other countries and regions by the end of March, Kastensmith said.
"We probably won't begin selling until June or July. There are some licensing issues we have to deal with — [Life Technologies'] Applied Biosystems and Roche and so forth," he added, referring to the core PCR IP estates owned by those entities.
InstantLabs also plans to license chemistry for various diagnostic assays in anticipation of initiating the US Food and Drug Administration regulatory process for medical devices by the end of this year, Kastensmith said.
The company hopes to supply pre-loaded MAC chips for testing more than 20 infectious agents including E. coli, salmonella, flu, HIV, hepatitis, malaria, MRSA, anthrax, West Nile virus, and tuberculosis; and said that the platform will allow customers to develop their own protocols and chemistry to test for other organisms of interest.
Should InstantLabs win regulatory approval for its device, it plans to target markets in developing nations and other regions of the world that might have limited access to core PCR facilities for diagnostic testing, "and I think there is a big market in the US, too," said Kastensmith. "If you look at different industries, such as food testing, veterinary, military, and diagnostics, there is room for this type of device."
So far, InstantLabs has raised about $5 million in three rounds of private equity funding, Kastensmith said. Li remains involved with the company as a board member and scientific advisor, and owns stock in the firm.
"We actually took this from Dr. Li and moved this from basically a science project from the university to a commercial product within what will be about a 24-month period," Kastensmith said. "So we did this very efficiently."