This article has been updated from a previous version to correct the spelling of InstantLabs' commercial partner Biolyph and clarify information about the Hunter platform.
By Ben Butkus
InstantLabs, a Reston, Va.-based firm founded in 2008 to commercialize a portable, point-of-need real-time PCR-based molecular testing platform, said this week that it has placed 20 beta versions of its instrument worldwide, primarily for food safety and product verification applications.
Eight of these placements, the company said, were to laboratories at various Middle East countries, where InstantLabs sees a rapidly developing market for food testing and infectious disease testing due to the area's large guest worker population, chairman and CEO Hans Kastensmith said this week.
In addition, InstantLabs is concurrently developing the first clinical diagnostic for the system — a molecular test for methicillin-resistant Staphylococcus aureus — which it expects to begin clinical trials for by the end of the summer, Kastensmith said.
InstantLabs came out of stealth mode in February 2010 by introducing the prototype of its flagship platform, the Hunter Accelerated PCR system, developed by University of Waterloo microfluidics and nanofluidics researcher Dongqing Li (PCR Insider 2/25/10).
The fully automated system features microfluidics-based sample prep, disposable testing chips with microliter-scale wells, miniaturized thermal cycling technology, and analysis software. According to the company's website, the system was originally designed to reduce the cost of molecular testing by as much as 15 percent and slash sample size and required reagents by 80 percent compared to current commercial platforms, although the company is in the process of updating those figures, a company spokesperson said.
The company spent the better part of 2010 placing alpha versions of the Hunter platform with various laboratories and, after aggregating user feedback, it made necessary adjustments and manufactured 30 beta units, 20 of which the company has placed with various testing partners, and 10 of which InstantLabs retained for further internal testing and refinement, Kastensmith told PCR Insider this week.
InstantLabs said that the eight instrument placements in the Middle East included users at food and beverage companies, ministries of health, and reference labs in countries such as Qatar, Iraq, Jordan, Lebanon, and Kuwait. Specific testers include the Jordan Food and Drug Administration, the Jordanian Army Lab, the Lebanese Agricultural Research Institute, and the AZM Bio Research Lab in Tripoli.
The company noted, for instance, that Qatar imports more than 90 percent of its food and has a large guest worker population, making foodborne pathogen and infectious disease testing a high priority. Other applications include measuring toxins and bacteria levels in the water supply.
InstantLabs claims that the portability, ease of use, and fast turnaround time of the Hunter platform allows municipal authorities, public health entities, and food companies to conduct such testing in a fraction of the time it would take to send samples to central reference laboratories for testing.
"We also placed some in other places around the world, such as in Southeast Asia and South America, and a couple in the US," Kastensmith said. "Some of them were purchased, and others were just placed for field trials in the interest of customer feedback."
If all goes well with the beta-testing phase, InstantLabs hopes to execute a global commercial launch of its platform in the next few months, Kastensmith said, noting that the company plans to have its "first 200 commercial units coming off the line at the end of this month."
So far, customer feedback has led InstantLabs to make most changes to the platform in the area of the user interface, not the core real-time PCR technology, according to Kastensmith.
"There were specific things [customers wanted], like being able to hit a touch screen with rubber gloves on," Kastensmith said.
"The biggest thing that we were dealing with was the systematic approach of sample preparation and understanding what really exists in many of the areas where we want to place this type of machine. There is a lack of centrifuges; a lack of knowledge of PCR diagnostics."
Even more specifically, he said, sample prep proved to be difficult for relatively unskilled workers, "so we got to see firsthand where people stumbled in using and preparing samples for this type of a system, and went back to the drawing board on our sample prep applications and protocols," Kastensmith said. "We have now streamlined that so that the chemistry is extremely easy to use."
Part of achieving that goal was striking an agreement with Biolyph, a contract research and manufacturing organization, to package InstantLabs' test reagents in Biolyph's LyoSphere technology, which is used to freeze dry the reagents for long-term storage and easy sample prep.
"So we mix our primers, probes, and master mix all into that small [package] … and you drop your prepared sample in there; it reconstitutes, and you're off to the races," Kastensmith said. "We had to find a master mix that would lyophilize well, and we've done that. We take our chemistries, send it [to Biolyph], they put it in the lyospheres, package it up, and send it back. It can ship without refrigeration. We haven't finished our shelf-life studies yet, but it's got a solid shelf life with no refrigeration."
As InstantLabs' early-access customers vet the latest version of the platform, the company is also developing tests for clinical diagnostics, starting with MRSA.
"We're going to aggressively pursue MRSA at the point of use," Kastensmith said. "The idea is to place these machines directly in emergency rooms and screen patients for MRSA prior to admittance. Right now we're working on finalizing a clinical trial for MRSA at a major US hospital, which we hope to get finalized before August."
Last year, InstantLabs said that it also eventually hopes to develop multiple assay disposable cartridges, or MACs, for a plethora of infectious disease agents, including Escherichia coli, salmonella, flu, HIV, hepatitis, malaria, anthrax, West Nile virus, and tuberculosis; and said that it envisions customers using the Hunter platform to develop their own protocols and chemistry to test for other organisms of interest.
This week, Kastensmith said that InstantLabs has narrowed its short-term focus a bit in terms of test development, and has its eye particularly on tuberculosis and Dengue fever testing.
"Tuberculosis has become a fairly large issue, especially in the Middle East, and we're focusing on that guest worker population," Kastensmith said. "In Qatar, they do about 60,000 tests per month on individuals applying for work." The United Arab Emirates and Kuwait perform about twice as many tests; while Saudi Arabia performs about four times as many, "so that's become a target market for us," he added.
"The second really large thing we're looking at is Dengue fever," Kastensmith said. "India has a real problem with this; as do the tropics and a good portion of Latin America and Southeast Asia. So that's another focus."
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