Lumora and Promega said this week that they have signed an agreement for the use of Promega's Ultra-Glo luciferase in Lumora's bioluminescent assay in real time, or BART, molecular diagnostics technology.
The agreement provides Lumora with a "quality-controlled" and extremely heat-stable luciferase to couple with its flagship BART platform, and will better equip the company to pursue its goals of developing molecular diagnostic tests with commercial partners and disseminating the BART technology to external partners for development work, a company official said.
For Promega, the deal represents the first commercial molecular diagnostic application for its Ultra-Glo luciferase product.
Based in Cambridgeshire, UK, Lumora spun out of the Institute of Biotechnology at the University of Cambridge in 2002 to further develop BART, which couples firefly luciferase-based reporter technology with isothermal amplification techniques for various molecular testing applications.
The BART method 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 chosen to couple it with isothermal amplification methods, which are similarly simple and inexpensive when compared to PCR-based amplification.
While Lumora has licensed the BART technology to other commercial entities for applied markets — for example, 3M for food safety testing and Biogal Galed Labs for veterinary diagnostics — it has also shifted its internal focus toward developing molecular diagnostic tests using BART.
In this latter area, Lumora's most significant partnership to date is with the Foundation for Innovative New Diagnostics to develop a rapid, high-throughput malaria diagnostic for the developing world by combining BART with a loop-mediated isothermal amplification-based malaria assay developed by FIND and Japan's Eiken Chemical (PCR Insider, 4/18/2013).
From the outset, Lumora had been using a luciferase reporter technology developed at the University of Cambridge. However, the company eventually began using Promega's Ultra-Glo luciferase, and recently finalized a supply agreement for the enzyme.
"There are only two enzymes out there which can be used in the BART system, and one of them is … Ultra-Glo," Lumora CEO Laurence Tisi told PCR Insider this week. "We developed one using some IP [from] Cambridge University, but we pretty soon began using the Promega one because they're selling it as a quality controlled reagent. We ended up very quickly using the Ultra-Glo pretty much exclusively, and have been using it for a while."
Ultra-Glo recombinant luciferase is designed to withstand variations in temperature, concentration of ionic detergents, and reducing agents, and is a key component in all of Promega's "Glo" brand reporter assays.
The majority of these assays, such as Nano-Glo, Bright-Glo, ONE-Glo, and Dual-Glo are designed for the visualization of cellular events or in chemical screens in drug discovery. The supply agreement with Lumora marks the first time the enzyme will be used in the molecular diagnostic realm.
Tisi said that Ultra-Glo is "more stable and heat-tolerant" than alternatives. "They've done a great job engineering the luciferase to be extremely heat-tolerant," he said. "It is a good enzyme, reliably sourced, and we trust Promega to be a good supplier of the reagent."
Using the enzyme in the BART system represents the first of a "new generation" of bioluminescent assays that take advantage of the ability of Ultra-Glo to operate at temperatures in excess of 60 °C, he noted.
Matthew Cook, head of commercial sales at Promega, said in a statement that Lumora "has some excellent technologies in the molecular diagnostics space which, combined with Ultra-Glo, have the potential to open new markets."
With the supply agreement finalized Lumora hopes to move forward with making the BART technology more readily available to third parties for development work while still pursuing its own MDx applications internally.
"We're at the stage now where we're very keen for other researchers to use the BART technology," Tisi said. "Now there's the access to hardware … and to reagents for those that want to use this platform. There are multiple applications, not just in diagnostics, but also as a development tool. The relationship we're building with Promega is the first step in making this more available to the research community."
Another important step will be the company's attendance at the American Association for Clinical Chemistry meeting to be held next week in Houston.
"This is the first year that Lumora has been actively exhibiting at clinical conferences, which reflects a change in the management team and a more aggressive approach now to establish our clinical partners," Tisi said.