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Lumora-FIND Malaria Screening Test May be Tip of Iceberg in MDx Development Partnership

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UK-based molecular diagnostics developer Lumora has partnered with the Foundation for Innovative New Diagnostics to develop a rapid, high-throughput malaria diagnostic assay to screen patients in the developing world.

The partnership will combine Lumora's bioluminescent assay in real-time, or BART, technology and expertise with a malaria assay developed by FIND and Japan's Eiken Chemical that is based on loop-mediated isothermal amplification, or LAMP.

The combination of these technologies, along with an inexpensive and easy-to-use instrumentation platform, is expected to yield a malaria assay that can be broadly deployed in resource-poor areas of the world to screen individuals for Plasmodia, the parasite that causes malaria.

In addition, the collaboration between Lumora and FIND is expected to eventually encompass other infectious disease targets, including an assay for HIV viral load, and is an important step in Lumora's efforts to gain a foothold for its BART technology in clinical markets, Hayden Jeffreys, commercial director at Lumora, told PCR Insider this week.

BART is a reporter system that can detect natural byproducts of nucleic acid amplification in real time and in a closed-tube environment without the use of additional reagents or expensive hardware. Due to the simplicity and low cost of the technique, Lumora has focused on coupling it with isothermal amplification methods, such as LAMP, which are similarly simple and inexpensive when compared to PCR-based amplification.

"In most cases, if pyrophosphate is generated [as it is in LAMP] BART can be sort of plugged in to become the reporter system, so you don't need to use … fluorescence as the endpoint," Jeffreys said. "You have this closed tube, real-time assay, which gives you a number of advantages, the biggest one of course being that you're not doing very precise thermal cycling, you've got a stable temperature. Isothermals straightaway give you a reduction in the complexity of the machinery required."

The company originally focused on using BART for molecular diagnostics, but briefly explored its use in food-testing applications. To that end, in 2006 it licensed isothermal amplification technology from BioMérieux to combine with BART for food safety assays.

However, in 2011 Lumora made a conscious effort to shift back to clinical diagnostics, and in that same year it licensed the BART technology to 3M, which is currently coupling it with LAMP in molecular food-testing assays (PCR Insider, 9/1/2011).

"Our real focus now … is to take the company into the clinical area," Jeffreys said. "We feel that is really where the technology can be applied. We're not looking to go head to head with Roche and Abbott and all the big guys in the central labs, but we're really looking to penetrate where PCR hasn't been able to because of its less-robust nature and expense."

Lumora's deal with 3M has actually been a boon for this move in more than one way, as Jeffreys said that it has served as proof of principle that the BART technology can enable molecular diagnostics to be performed "in really crappy conditions, like a food microbiology lab where it's humid and dirty and you've got non-specialists running those tests," Jeffreys said. "That's really the advantage we bring to the table here for people like FIND. You can see this being used in a lower-skilled lab, and being used in screening."

In December 2011 Lumora scientists published a paper specifically demonstrating how BART could be used with LAMP, and said that it would likely develop most of its future assays by combining the two techniques — noting that potential commercial partners would need to license the LAMP technology from Eiken should they work with Lumora to commercialize tests based on the combined methods (PCR Insider, 1/5/2012)

Enter FIND, which in September 2011 said that it had begun clinical field trials for a LAMP-based assay for African sleeping sickness developed in collaboration with Eiken — a partnership that also extends to diseases such as malaria and tuberculosis (PCR Insider, 9/15/2011).

As such, the pieces were in place for a partnership between Lumora and FIND to try to commercialize a test for at least one of these infectious diseases — initially malaria, under the deal announced this week.

"FIND is moving from almost single-test utility to a screening program with us, and our technology allows you to screen multiple patient samples very quickly," Jeffreys said. "They've brought some technology to the partnership, and we've brought in the BART technology and some other bits and pieces. It's more than just a funding relationship — they've actually brought some valuable technology that, when combined with ours, provides this very powerful ability to screen very large numbers of patient samples."

Germany's Federal Ministry of Education and Research, BMBF, is providing an unspecified amount of funding for the Lumora-FIND project. In March 2012 BMBF announced it was granting €7.5 million (just under $10 million at the time) to FIND to support the ongoing development of molecular technologies to diagnose a variety of diseases affecting people in primarily developing nations.

Jeffreys said that if all goes as planned, the partners will have a commercial-ready product in about six months. At that point, Lumora and FIND would likely seek a third-party molecular diagnostics company to help manufacture and market the assay, he added.

"Lumora doesn't have a sales and marketing organization, and we don't do manufacturing," he said. "We're a development organization, up to pilot manufacturing, and we transfer that to a third party for commercialization."

The company has, however, developed a prototype instrument for the malaria assay consisting of a simple photodiode-based luminometer and heating block. "If you look at the nuts and bolts of the instrument, excluding a pretty case, you're only talking about $400," Jeffreys said. "The instruments are very low-cost, very robust, and they don't need to be calibrated. It means that these things can be used in places where you simply couldn't take PCR or a pyrosequencer."

Should the malaria test partnership prove fruitful, Lumora and FIND have other assays in the pipeline, including an HIV viral load test based on the same technology that Lumora has been developing.

"This is part of a rolling program that we are developing with [FIND], and … there are quite a few assays that will come through this system," Jeffreys said. "Our ambition at Lumora is to make BART a cornerstone of these sorts of diagnostics."

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