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Luminex Gears Up to Introduce Its First microRNA Products Through Co-Development Deal with Exiqon

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In a bid to establish a foothold in the growing microRNA marketplace, Luminex said this week that it has signed a deal with Exiqon to develop products combining their key technologies for miRNA detection.
 
The products will marry Luminex’s xMAP bioassay technology with Exiqon’s Locked Nucleic Acids and will be the first miRNA offerings from Luminex, which took its first steps in the field earlier this year when it signed a non-exclusive intellectual property-licensing deal with the Massachusetts Institute of Technology (see RNAi News, 3/2/2006).
 
Under the terms of the new deal, the companies will co-develop the products. Exiqon will handle manufacturing, while Luminex will be responsible for commercialization.
 
Patrick Balthrop, president and CEO of Luminex, told RNAi News this week that while details of the company’s commercialization strategy for the miRNA detection products have not been disclosed, “we intend to access the market through our partners.
 
“One of the benefits that Luminex has commercially is that we have a number of partners that are worldwide in scope and give us significant reach into the marketplace — companies like PerkinElmer, Bio-Rad’s life science group, [and] Qiagen,” he said. “It is our intent to reach into the marketplace by taking advantage of those existing partnership agreements and distribution agreements.”
 
Additional terms of the deal, including the financials, were not disclosed.
 
Product Specs
 
According to Balthrop, the miRNA products under development will be capable of detecting the roughly 328 human mature miRNAs in the Wellcome Trust Sanger Institute’s miRBase, version 8.0. “It will also incorporate the relevant number of microRNAs for mouse and rat — that number is around 130,” he added.
 
The products will involve binding Exiqon’s LNAs — a class of nucleic acid analogs in which the ribose ring is locked by a methylene bridge connecting the 2'-O atom with the 4'-O atom in order to boost affinity and stability — to the surface of Luminex’s xMAP microspheres, or beads, which carry fluorescent dyes for various color combinations.
 
The LNAs capture specific miRNAs in a sample and bind them to the beads, which “are combined in one reaction well at one time,” Balthrop explained. The beads are then analyzed by flow cytometry, with the different colors corresponding to specific miRNAs present in the sample.
 
“The users [are expected to] be the scientific and medical researchers who are typically characterizing tissue sample to determine what microRNAs might be active and which are not,” he said.
 
“The way they do that today is … using a two-dimensional array product,” Balthrop said. “The disadvantage [with this method] is that frequently those two-dimensional arrays are constructed in such a way that the customer is … paying for … microRNAs they don’t use. For example, [these arrays] … will almost always have all the relevant microRNAs on the chip, but if you’re [only] testing mouse samples or human samples, by definition there are ones on the chip that you don’t need.”
 
Luminex’s planned miRNA products, in contrast, will include both comprehensive detection tools — one for all the human miRNAs in the Sanger database and one for all the mouse and rat miRNAs — as well as a second-generation line that will be customizable.
 
The company also anticipates that its miRNA detection products will gain traction in the market by offering improved specificity, largely as a result of the LNAs.
 
“MicroRNAs … are about 25 [nucleotides] in length,” Balthrop said. “The difference between one microRNA and another microRNA might very well be only one of those [nucleotides], and it might be near the end of the chain. If all of those sequences are exposed at one time without a Locked Nucleic Acid format, you get a lot of cross talk and a lack of specificity.
 
“The ability to multiplex in combination with the Locked Nucleic Acid methodology provides what we expect to be a level of specificity that will be best-in-class,” he added.
 


“One of the benefits that Luminex has commercially is that we have a number of partners that are worldwide in scope and give us significant reach into the marketplace. … It is our intent to reach into the marketplace by taking advantage of those existing partnership agreements and distribution agreements.”

Luminex anticipates that the initial two products developed under the deal with Exiqon — the comprehensive human and mouse/rat miRNA detection tools — will roll out by the end of the year. The company anticipates launching follow-on products as the miRNA field matures.

 
“The microRNA field is moving very fast, so we have plans in place to modify the product as called for based on whatever the science indicates is called for,” Balthrop said. “In other words, if the Sanger database changes over time, we will change the product to reflect that.”
 
Luminex also sees possibilities for miRNA products beyond basic research — namely diagnostics.
 
When the company signed its deal with MIT, it picked up the rights to the institute’s miRNA IP for both life science research and clinical diagnostics.
 
Additionally, last year researchers from the Broad Institute, MIT, the Dana-Farber Cancer Institute, St. Jude's Children's Research Hospital, and Harvard Medical School published research showing that Luminex’s xMAP beads could be used to classify human cancers by their miRNA expression profiles (see RNAi News, 5/17/2005).
 
“Luminex will follow the science,” Balthrop said. “In other words, as the scientific and medical researchers do their work, and if the hypothesis … that microRNAs play a specific role in various types of cancers and infectious diseases … is confirmed … and turns into a diagnostic opportunity, we’re very well-positioned to take advantage of that opportunity.”
That said, he noted that “we anticipate most of the [miRNA] activity in the next [few] years will be in the scientific and medical research category, rather than the diagnostics category.”

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